Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention
Phase: NA
Conditions: Chronic Grief, Dementia Family Caregivers
Sponsor: Rush University Medical Center

Protocol Template, Version 3.0
Clinical Interventional Study 
Protocol 
ORA: 18041811-IRB01   Date IRB Approved: 6/24/2019   Amendment Date: 5/4/2020

Protocol Template, Version 3.0
Dementia Caregiver Chronic Grief Management: A Live Online 
Video Intervention (CGMI-V)
A randomized, longitudinal 144-subject clinical trial of a live online, group-based video 
intervention addressing dementia caregivers’ chronic grief management within the first two years 
post long-term care placement of a family member with dementia.
Principal Investigator:
Olimpia Paun, PhD, PMHCNS-BC, FGSA
Associate Professor, Rush University College of Nursing
 Supported by:
The National Institute on Aging
Grant #1R01AG056393-01A1  
 
(Any modification to the protocol should be annotated on the coversheet or in an appendix.  The 
annotation should note the exact words that are changed, the location in the protocol, the date 
the modification was approved by the Executive Committee, and the date it became effective.) 
Version 2 
April 15, 2020
ORA: 18041811-IRB01   Date IRB Approved: 6/24/2019   Amendment Date: 5/4/2020

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TABLE OF CONTENTS
Page
PRÉCIS..........................................................................................................................................iv
Study Title..................................................................................Error! Bookmark not defined.
Objectives ...................................................................................................................................iv
Design and Outcomes.................................................................................................................iv
Interventions and Duration .........................................................................................................iv
Sample Size and Population .......................................................................................................iv
STUDY TEAM ROSTER .............................................................................................................1
Principal Investigator: Olimpia Paun, PhD, PMHCNS-BC, FGSA ............................................1
Co-Investigators: Sarah Ailey, PhD, APHN, Carol J. Farran, DNSc, FAAN, Louis Fogg, PhD, 
Ben R. Inventor, PhD, RN, GNP, Arlene Miller, PhD, RN, FAAN ............1
PARTICIPATING STUDY SITES ................................................Error! Bookmark not defined.
1
Study objectives .....................................................................................................................3
1.1
Primary Objective............................................................................................................3
1.2
Secondary Objectives ......................................................................................................3
2
BACKGROUND AND RATIONALE .................................................................................3
2.1
Background on Condition, Disease, or Other Primary Study Focus ...............................3
2.2
Study Rationale................................................................................................................4
3
STUDY DESIGN ...................................................................................................................8
4
SELECTION AND ENROLLMENT OF PARTICIPANTS...........................................10
4.1
Inclusion Criteria ...........................................................................................................10
4.2
Exclusion Criteria ..........................................................................................................11
4.3
Study Enrollment Procedures ........................................................................................11
5
STUDY INTERVENTIONS ...............................................................................................12
5.1
Interventions, Administration, and Duration.................................................................12
5.2
Handling of Study Interventions....................................................................................14
5.3
Concomitant Interventions.............................................................................................14
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5.3.1
Allowed Interventions ...............................................................................................14
5.3.2
Required Interventions...............................................................................................14
5.3.3
Prohibited Interventions.............................................................................................14
5.4
Adherence Assessment ..................................................................................................14
6
STUDY PROCEDURES .....................................................................................................14
6.1
Schedule of Evaluations ................................................................................................15
6.2
Description of Evaluations ............................................................................................16
6.2.1
Screening Evaluation.................................................................................................16
6.2.2
Enrollment, Baseline, and/or Randomization ............Error! Bookmark not defined.
6.2.3
Follow-up Visits ........................................................................................................17
6.2.4
Completion/Final Evaluation.....................................................................................18
7
SAFETY ASSESSMENTS..................................................................................................18
7.1
Specification of Safety Parameters................................................................................19
7.2
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters.....19
7.3
Adverse Events and Serious Adverse Events ................................................................19
7.4
Reporting Procedures.....................................................................................................20
7.5
Follow-up for Adverse Events.......................................................................................21
7.6
Safety Monitoring..........................................................................................................21
8
INTERVENTION DISCONTINUATION ........................................................................21
9
STATISTICAL CONSIDERATIONS...............................................................................21
9.1
General Design Issues....................................................................................................21
9.2
Sample Size and Randomization ...................................................................................24
9.2.1
Treatment Assignment Procedures............................................................................24
9.3
Interim analyses and Stopping Rules.............................................................................25
9.4
Outcomes .......................................................................................................................25
9.4.1
Primary outcome........................................................................................................25
9.4.2
Secondary outcomes ..................................................................................................26
9.5
Data Analyses ................................................................................................................26
10
DATA COLLECTION AND QUALITY ASSURANCE.................................................28
10.1
Data Collection Forms...................................................................................................28
10.2
Data Management..........................................................................................................28
10.3
Quality Assurance..........................................................................................................28
10.3.1
Training..................................................................................................................28
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10.3.2
Quality Control Committee ...................................................................................29
10.3.3
Metrics ...................................................................................................................29
10.3.4
Protocol Deviations ...............................................................................................29
10.3.5
Monitoring .............................................................................................................29
11
PARTICIPANT RIGHTS AND CONFIDENTIALITY..................................................30
11.1
Institutional Review Board (IRB) Review ....................................................................30
11.2
Informed Consent Forms ...............................................................................................30
11.3
Participant Confidentiality.............................................................................................30
11.4
Study Discontinuation ...................................................................................................31
12
ETHICAL CONSIDERATIONS .......................................................................................31
13
COMMITTEES ...................................................................................................................33
14
PUBLICATION OF RESEARCH FINDINGS.................................................................33
15
REFERENCES ....................................................................................................................33
16
SUPPLEMENTS/APPENDICES .......................................................................................35
I. Procedures Schedule
II. Informed Consent Form Template
III. Other 
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PRÉCIS 
 Dementia Caregiver Chronic Grief Management: A Live Online Video Intervention 
(CGMI-V)
A randomized, longitudinal 144-subject clinical trial of a live online, group-based video
intervention addressing dementia caregivers’ chronic grief management within the first two 
years post long-term care placement of a family member with dementia.
Objectives 
The primary objective of this Stage I clinical trial is to determine whether the 8-week 
CGMI-V has an effect on dementia family caregivers’ chronic grief. Secondary 
objectives are to determine whether the CGMI-V has an effect on dementia family 
caregivers’: (1) symptoms of depression and anxiety, (2) positive states of mind, (3) 
satisfaction with care provided in the long-term care facility and (4) conflict with staff. 
In addition, we will explore mechanisms of intervention impact on caregiver outcomes.
Design and Outcomes  
The study is a Stage I longitudinal randomized clinical trial to test the effects if the 
CGMI-V on caregivers’ chronic grief, mental health (symptoms of depression and 
anxiety; positive states of mind) and facility-related (satisfaction with care and conflict 
with facility staff) outcomes. 144 Alzheimer’s disease or a related dementia (ADRD) 
caregivers whose family members are in long-term care facilities will be randomly 
assigned to either CGMI-V or a Minimal Treatment (MT) control condition. For both 
conditions, data will be collected at baseline (pre-intervention), 8 weeks (immediately 
post-intervention) for intervention effects, and 24 weeks post baseline for maintenance 
effects.
Interventions and Duration 
Caregivers in the CGMI-V condition will participate in eight weekly professionally led, 
real-time, live-streaming online video group sessions. Those caregivers in the MT 
control condition will receive written information materials about late-stage ADRD at 
baseline. For both conditions, caregivers are expected to be in the study for a total of 24 
weeks. 
Sample Size and Population 
A total of 144 ADRD family caregivers will be randomized to either CGMI-V condition 
(N = 72) or Minimal Treatment (MT) (N = 72). Caregivers will be males and females of 
any race or ethnic background, 21 years of age and over, whose family members are 
diagnosed with ADRD and have been residing in long-term care for under one year.
ORA: 18041811-IRB01   Date IRB Approved: 6/24/2019   Amendment Date: 5/4/2020

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STUDY TEAM ROSTER 
Principal Investigator: Olimpia Paun, PhD, PMHCNS-BC, FGSA
Rush University College of Nursing, 600 S. Paulina, #1080, 
Chicago, IL, 60612
Telephone: 312.942.6996
Fax: 312.942.6226 
e-mail: olimpia_paun@rush.edu
Key roles: assumes scientific responsibility for entire project, 
monitors budget management, oversees study operations, 
supervises all study personnel, coordinates activities of the 
research team, and collaborates with Co-Investigators on 
dissemination of study findings.
Co-Investigators:       Sarah Ailey, PhD, APHN
Rush University College of Nursing, 600 S. Paulina, #1080, 
Chicago, IL, 60612
Telephone: 312.942.3383
Fax: 312.942.6226 
e-mail address: Sarah_H_Ailey@rush.edu
Main responsibilities/Key roles: provides initial and ongoing 
training for the interventionists and data collectors, attends 
monthly meetings with PI and data collectors to address issues 
that arise in administering study instruments, provides ongoing 
fidelity checks, collaborates in the preparation of papers for 
presentation/publication.
Masako Mayahara, PhD, RN, FPCN, CHPN
Rush University College of Nursing, 600 S. Paulina, #1080, 
Chicago, IL, 60612
Telephone: 312.942.3183
Fax: 312.942.6226
e-mail address: Masako_Mayahara@rush.edu
Key roles: assures consistent implementation of study design, 
focuses key analysis on assessment of primary outcome 
measures, and collaborates in the preparation of papers for 
presentation and publication.
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Louis Fogg, PhD
Rush University College of Nursing, 600 S. Paulina, #1080, 
Chicago, IL, 60612
Telephone: 312.942.6239
Fax: 312.942.6226
e-mail address: Louis_Fogg@rush.edu
Key roles: sets up the sampling frame, develops the coding 
manual, trains the data manager, oversees data coding and 
computer entry quality, tracks subject attrition, cleans/reduces 
data set, transforms data as needed, programs for specific 
statistical procedures, analyzes/interprets statistical output, and 
collaborates in preparation of papers for presentation and 
publication.
                                 Ben Inventor, PhD, RN, GNP
Rush University College of Nursing, 600 S. Paulina, #1080, 
Chicago, IL, 60612
Telephone: 312. 942.
Fax: 312.942.6226
e-mail address: ben_r_inventor@rush.edu
Key roles: assists in recruitment, especially in that of African 
American participants, provides ongoing fidelity checks, and 
collaborates in the preparation of papers for presentation and 
publication.
Arlene Miller, PhD, RN, FAAN
Rush University College of Nursing, 600 S. Paulina, #1080, 
Chicago, IL, 60612
Telephone: 312.943.4731
Fax: 312.942.6226 
e-mail address: Arlene_Miller@rush.edu
Key roles: provides focused training for interventionists/data 
collectors in strategies on how to respond to high levels of 
grief, depression, and verbalized suicidal/homicidal ideation, 
attends bi-monthly team meetings with the PI and 
interventionists, and collaborates in the preparation of papers 
for presentation and publication.
PARTICIPATING STUDY SITES 
Rush University College of Nursing in Chicago, Illinois is the only study site.
ORA: 18041811-IRB01   Date IRB Approved: 6/24/2019   Amendment Date: 5/4/2020

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1
STUDY OBJECTIVES
1.1
Primary Objective
The primary objective of this Stage I clinical trial is to determine whether the 8-week 
CGMI-V has an effect on dementia family caregivers’ chronic grief. We hypothesize that 
caregivers in the CGMI-V condition compared to those in the MT control condition will 
report decreased chronic grief levels.
1.2
Secondary Objectives 
Secondary objectives are to determine whether the CGMI-V has an effect on dementia 
family caregivers’: (1) symptoms of depression and anxiety, (2) positive states of mind, (3) 
satisfaction with care provided in the long-term care facility and (4) conflict with staff. 
We hypothesize that:
•
Caregivers in the CGMI-V compared to those in the MT control condition will 
report decreased symptoms of depression and anxiety and increased positive states 
of mind.
•
Caregivers in the CGMI-V compared to those in the MT control condition will 
report increased satisfaction with care provided in the long-term care facility and 
decreased conflict with facility staff.  
In addition, we will explore mechanisms of intervention impact on caregiver outcomes. We 
hypothesize that CGMI-V works by changing the exacerbators of chronic grief: lack of 
knowledge about late-stage ADRD, sense of loss, guilt, and caregiver role captivity.
2
BACKGROUND AND RATIONALE 
2.1
Background on Condition, Disease, or Other Primary Study Focus
In 2017, an estimated 16 million family caregivers provided approximately 18.4 billion 
hours of unpaid care to relatives with Alzheimer disease and related dementias (ADRD), 
valued at US $232.1 billion.1 As the disease progresses, close to 75% of persons with 
ADRD are eventually being placed in long-term care facilities (LTCFs), where they reside 
for on average 2 years prior to death. The caregiving process from home care through long-
term placement spans on average 5 to 10 years, which comes with a high price for 
caregivers’ physical and mental health.1 Compared to age-matched non-caregivers, ADRD 
family caregivers made twice as many personal emergency room visits and three times as 
many physician office visits over an 18-month period.2 In 2017, the prevalence of 
depression in ADRD family caregivers was up to 40%, a much higher level compared to 
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age-matched non caregivers.  Overall, in 2017, the physical and emotional impact of ADRD 
caregiving resulted in an estimated US$11 billion in family caregiver health care costs in the 
United States.1 
Evidence suggests that, after long-term care placement, ADRD family caregivers experience 
new feelings of loss, guilt, and role captivity (e.g., feeling trapped in the caregiver role).3 
These feelings can exacerbate caregivers’ ongoing symptoms of chronic grief, depression, 
and anxiety, and place them at increased risk for suicide.3-10 These symptoms, in turn, may 
contribute to caregiver conflict with LTCF staff and dissatisfaction with care.11,12 With the 
growing number of caregivers who place family members with ADRD in LTCFs, it is 
imperative to develop interventions that address their mental health needs, including chronic 
grief.
2.2
Study Rationale
The Stress Process Model13 has been the predominant paradigm used for interventions with 
ADRD family caregivers. Interventions based on this model emphasize caregiver 
knowledge, communication, and conflict resolution, problem-solving, end-of-life care 
planning, and coping. Accordingly, improvements were found in each of these targeted 
domains. Overall, though, fewer studies found significant improvement in caregiver mental 
health outcomes, such as symptoms of depression and anxiety, and burden.14 We speculate 
that this may be due to lack of attention to ADRD family caregivers’ reactions to loss and 
grief. In general, grief is considered a normal reaction to loss (i.e., loss of loved one, 
relationship, role, status). However, in ADRD caregiving, grief often becomes chronic 
because losses accumulate over time.10,15-17 Grief intensity reaches high levels during the 
last two years of caregiving before death, when most persons with ADRD are in long-term 
care.18 Further, Givens and colleagues19 found that caregivers with high grief levels prior 
to the care recipient’s death had even higher levels of grief seven months post death. Thus, 
it is essential not to wait and to treat grief prior to the care recipient’s death. Meuser and 
colleagues20,21 proposed that, in ADRD caregiving, chronic grief affects caregivers’ 
depressive symptoms, stress, and burden. These grief-related findings laid the foundation 
for a paradigmatic shift from the Stress Process model13 to a grief-centered paradigm and 
formed the basis for reframing new ADRD caregiving interventions. 
Research is increasing that examines caregiver chronic grief as a defining aspect of the 
ADRD caregiving experience that contributes to caregiver symptoms of depression and 
anxiety.22 To date, we know of two studies that tested the effects of grief interventions on 
ADRD caregiver outcomes; both were conducted by professionals before placement of the 
care recipient in long-term care. The first study23 consisted of a brief, 5-week psycho-
educational group intervention designed to address loss and grief in ADRD community-
based caregivers. In that study, caregiver grief increased from pre to post treatment.23 
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These findings suggest that the 5 weeks may have been too short for caregivers to process 
their grief. A longer grief intervention (5 months) was used by other investigators.24 That 
intervention included community-based ADRD spouse caregivers who received 
individualized sessions delivered weekly over 5 months with follow-up at 8 months post 
baseline. At five months, improvements were found in grief, symptoms of depression, and 
anxiety for all participants. At the eight-month post-baseline follow-up, the positive 
outcomes were sustained for all except those caregivers whose spouses had been placed in 
long-term care or had died. These findings suggest that ADRD caregivers needed to 
continue receiving a grief intervention even after they placed their family member in long-
term care to maintain improvements in grief and symptoms of depression and anxiety.24 
Therefore, we created an intervention that targets ADRD caregiver’s chronic grief after 
LTC placement based on a grief-centered paradigm that expands the existing Stress 
Process Model. 
We designed the Chronic Grief Management Intervention (CGMI) for ADRD 
Caregivers (PI: Paun, O.; Co-Is Farran, C.J., & Fogg, L). Funding: NINR-R21NR010577, 
2008-2011.25,26 as a 12-week group intervention to improve caregivers’ (1) knowledge of 
late-stage ADRD; (2) communication, conflict resolution, and chronic grief management 
skills; and (3) grief and mental health outcomes. We pilot-tested the effects of CGMI in a 
pre-test/multiple post-test design with random assignment of 16 long-term care facilities to 
either the 12-week CGMI or an attention control condition. Data were collected at 
baseline, 3 months (immediately post-intervention) and 6 months (post-baseline). The 
content was structured into three major components: (1) knowledge about late-stage 
ADRD, (2) communication and conflict resolution skills, and (3) chronic-grief-
management skills. Those in the attention control condition received two brief minimal-
support phone calls at weeks 6 and 18.  
Results: Of the total 151 referrals from 16 facilities, 114 ADRD caregivers were screened, 
and 93 were eligible and enrolled (n = 37 in CGMI; n = 56 in control). The average 
caregiver age was 60.69 (SD 10.64), while the average age for the care recipient was 83.38 
(SD 6.46). The caregivers were predominately Caucasian (87%). Caregivers and care 
recipients were predominantly female (88%, 74% respectively). Approximately two-thirds 
of caregivers were adult children. The average time since care recipients’ placement in 
long-term care was 7.10 months (SD 6.80).26 Overall retention was 89% (n = 34 in CGMI; 
n = 49 in control). Reasons for dropout were death of the care recipient, caregiver medical 
problems, and lack of time. A total of 8 distinct groups of caregivers received the CGMI. 
Attendance averaged 10.44 sessions out of 12 (SD 1.50, R 5-12). At 3 months, we found 
significant improvement in the intervention group in heartfelt sadness and longing (p = 
.027) and promising effect sizes (ES) in the intervention group scores with a decrease in 
heartfelt sadness and longing (0.49), loss of relationship (0.33), and guilt (0.29). At the 6-
month follow-up, we found a significant drop in guilt (p = .029) in the intervention group 
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and sustained ES in caregivers’ scores on heartfelt sadness and longing (0.38), loss of 
relationship (0.30), and guilt (0.49). At the 3- and 6-month follow-ups, caregivers reported 
feeling highly satisfied with the information learned in the group discussions (92%) and 
with the interventionists’ approach (100%). A number of caregivers suggested that there be 
fewer sessions due to the burden of time. Further, key staff informants (directors of 
nursing, unit managers, and administrators) at all 16 long-term care facilities (LTCFs) 
reported back to recruiters that there were caregivers who expressed interest in the 
intervention but were constrained due to distance and travel to attend weekly meetings at 
the facilities. 
Relevance for the proposed study: CGMI results supported feasibility for recruitment, 
retention, and attendance. Retention for the CGMI condition was more than 90%. Increase 
in caregiver knowledge, improvement in heartfelt sadness and longing, and decrease in 
guilt at 3 months, with sustained effects in further decreased guilt at 6 months, are 
promising results. The fact that guilt continued to decrease in the intervention group 3 
months after intervention completion is significant because guilt is one of the grief-
associated feelings that can exacerbate conflict with LTCF staff and reduce satisfaction 
with care. Based on the established feasibility, effects, and caregiver and key informant 
feedback, we adapted CGMI in several ways. First, we reduced the 12 weeks of 
intervention delivery to 8 weeks, maintaining the content in core target areas of the 
intervention as follows: (1) we condensed the content on knowledge to that most relevant 
to late-stage ADRD from three to two sessions, (2) we condensed the content on 
communication/conflict resolution skill and hands-on care to the most relevant LTC 
situations from three to two sessions, and (3) we maintained the focus on grief processing 
and grief management skills in a  more condensed format from six to four sessions. 
Second, the intervention was adapted to be delivered via a professionally led, live-
streaming video, online group format to accommodate distance participation. 
Chronic Grief Management – A Live-Streaming Video Online Intervention (CGMI-
V) (PI: Paun, O.; Co-I Cothran, F; Rush University College of Nursing Research Fund, 
2016-2017)27. The purposes of this study were: (1) to determine the feasibility 
(recruitment, retention, attendance) of delivering the adapted 8-week CGMI-V in a 
professionally led, live-streaming video online group format and (2) to explore ADRD 
caregivers’ group experience using online video-based technology. Methods: This was a 
single-group study with data collection at baseline (caregiver/care recipient demographics) 
and at 8 weeks (caregiver brief survey and focus group). Prior to intervention 
implementation, each caregiver received a study-provided iPad with a password-protected 
link to Adobe Connect. Individual orientation training in the use of the software and 
equipment was provided by a technology assistant. The manualized intervention was 
delivered over 8 weeks in 60-minute real-time, online video sessions by the PI. The 
technology assistant was present either in-person or remotely at each session to provide 
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assistance to the interventionist and study participants as needed. Recruitment, retention, 
and attendance were tracked in a Microsoft Access data base. Post intervention, 
participants completed a 5-item survey and rated on a scale from 0 = not at all to 4 = very 
much how much they learned from the intervention content (knowledge, communication 
and conflict resolution skills, grief management skills) and the extent of their use of the 
new knowledge and skills. In addition, a post-intervention focus group that was taped and 
transcribed covered: (1) participants’ experience with the technology (ease of use, 
technical problems, and orientation to online platform and iPad devices) and (2) 
participants’ experience with the live-streaming video online group format (ability to relate 
to each other emotionally, the group’s effect on emotional outcomes). 
Results: Five ADRD family caregivers responded to a notice placed in a LTCF newsletter. 
The four female and one male caregivers were all Caucasian, and so were their care 
recipients. Only one caregiver was older than 75 years. Three were adult children of the 
care recipients, one was a spouse, and one was a niece. All caregivers attended at least 5 or 
more sessions, with 3 of 5 attending all eight sessions. Three caregivers were able to attend 
and not miss sessions when they were traveling away from home. In the post-intervention 
focus group, caregivers (n = 5) reported no major problems with navigating the WebEx 
platform and the iPad technology. They found the individualized orientation and ongoing 
support by the technology assistant contributed to successful handling of the technology. 
The most frequent technological problem was an echo, which was addressed at the 
beginning of each session by fine tuning each caregiver's study-provided headset and iPad 
volume and microphone levels. Frozen images occasionally became a problem when 
caregivers were traveling, due to weaker local Wi-Fi capacity. However, those caregivers 
were able to continue the session without interruption using the audio function. 
Importantly, caregivers reported that the online environment did not interfere with their 
ability to relate to each other emotionally, especially because they could see each other via 
WebEx live-streaming video. Participants indicated that the group size was ideal for the 
online group interaction and thought that a group larger than 6 would make it more 
difficult to relate to each other. Consistent with findings in our previous CGMI study, 
caregivers reported that the intervention helped decrease their sense of guilt and isolation. 
This was further supported by post-intervention survey results: the highest agreement rate 
between participants was that the group discussions helped them process their loss and 
grief associated with long-term care placement 3.6/4 (0.55)27. 
Relevance for the proposed study: this pilot found the use of an online platform and iPad 
technology feasible for the group-based online delivery of the CGMI-V in a professionally 
led, synchronous video format. ADRD caregivers reported no major technological 
difficulties and were able to relate to each other in an online environment.
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3
STUDY DESIGN
This study is a Stage I longitudinal randomized clinical trial. ADRD caregivers whose 
family members are residing in long-term care facilities (LTCFs) will be recruited, 
screened for inclusion criteria, and randomly assigned to either CGMI-V or a Minimal 
Treatment (MT) control condition. Caregivers in the CGMI-V will participate in eight 
weekly, professionally led, real-time, live streaming video online group sessions. Those 
caregivers in the MT condition will receive written information materials about late stage 
ADRD at baseline. For both conditions, data will be collected at baseline (pre-
intervention), 8 weeks (immediately post-intervention) for intervention effects, and at 24 
weeks post-baseline for maintenance effects.
Primary Outcome: Controlling for background variables, establish effect sizes of the 
CGMI-V condition and Minimal Treatment (MT) control condition on changes in caregiver 
chronic grief. We hypothesize that caregivers in the CGMI-V condition compared to those 
in the MT control condition, will report decreased chronic grief levels.
Secondary Mental Health Outcomes: Controlling for background variables, establish effect 
sizes of the CGMI-V and Minimal Treatment (MT) control condition on changes in 
caregiver symptoms of depression and anxiety and on positive states of mind. We 
hypothesize that caregivers in the CGMI-V condition compared to those in the MT control 
group will report (2.1) decreased symptoms of depression and anxiety and (2.2) increased 
positive mental states. 
Secondary Facility-related Outcomes: Controlling for background variables, establish 
effect sizes of the CGMI-V condition and the Minimal Treatment (MT) control condition 
on changes in caregiver satisfaction with care provided in the facility and conflict with 
staff. We hypothesize that caregivers in the CGMI-V condition compared to those in the 
MT control condition will report (3.1) increased satisfaction with care provided in the 
facility and (3.2) decreased conflict with staff. 
Mechanism of Intervention Outcome: Explore mechanisms of intervention impact on 
caregiver outcomes. We hypothesize that CGMI-V works by changing the exacerbators of 
chronic grief: lack of knowledge, sense of loss, guilt, and role captivity.
Study population and location: We will recruit a sample of 144 ADRD caregivers who have 
a family member residing in dementia care or memory care units in long-term care facilities 
located in the Chicago metropolitan area. We have well-established collaborating 
relationships with 35 long-term care facilities that will give us access to a diverse pool of 
approximately 1,000 ADRD family caregivers. Caregivers will be randomly assigned to 
either the CGMI-V condition (n=72) or the MT control condition (n=72). Caregivers will 
receive the CGMI-V intervention at home or another location of their choosing, using iPads 
with an online platform (WebEx). Caregivers in the MT condition will receive written 
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information about late stage ADRD at baseline. Each individual caregiver is expected to be 
in the study for a total of 24 weeks from enrollment to follow-up.
Study implementation: The study will be implemented in six waves. Beginning in Month 5 
of the study, we will start recruiting and enrolling 24 caregivers for Wave 1, who will be 
randomly assigned to either the CGMI-V condition (n = 12; 6/group) or MT control 
condition (n = 12). After these 24 caregivers have been enrolled, the study team will start 
recruiting and enrolling an additional 24 caregivers for Wave 2. There will be a total of six 
waves. Each wave will have 8 weeks to recruit, screen, enroll, randomize to condition, and 
complete baseline data collection, followed by 8 weeks to implement the intervention 
condition, and data collection immediately post-intervention and 24 weeks from baseline 
follow-up. Once enrollment is completed for a wave, recruitment will start for the following 
wave. This pattern will be the same for all six waves. This will result in 144 caregivers 
being enrolled, 72 for the CGMI-V condition, and 72 for the MT control condition. Figure 1 
illustrates the progression of the study waves through the study timeline. 
Intervention: For the CGMI-V intervention condition, study materials (participant manual, 
technology instructions) will be sent to participants electronically. We will mail hard copies 
of the manual and technology instructions to those caregivers who prefer to have them 
printed out. The iPad tablet and the earbuds with microphone will be mailed to participants 
prior to the first session. As needed, caregivers will receive an individualized over-the-
phone orientation (20-30 minutes) in the operation of the equipment from the technology 
assistant. Each session will start with a brief technology check-up and review of ground 
rules including maintaining confidentiality. 
Each CGMI-V group session will be conducted by one interventionist who has therapeutic 
group leading experience. For treatment fidelity purposes, the study interventionists will be 
trained in the delivery of the group intervention and the iPad and online technology. Each 
group will have not more than six participants. The intervention consists of approximately 
60-minute sessions delivered weekly for eight consecutive weeks and will follow the 
standardized CGMI-V intervention manual (Appendix A). 
Figure 1. Ordering of Administering Treatment Conditions
Study
Week
4
8
12
16
20
24
28
32
36
40
44
48
52
56
60
64
68
72
76
80
84
88
92
96 100 104 108 112 116 120 124 128 132
n=12
n=12
n=12
n=12
n=12
n=12
n=12
REC = Recruitment
n=12
CGMI-V = Chronic Grief Management Intervention Video
n=12
MT = Minimal Treatment
n=12
n=12
n=12
REC
CGMI-V
Follow-up
REC
MT
Follow-up
REC
CGMI-V
Follow-up
REC
MT
Follow-up
REC
CGMI-V
Follow-up
REC
MT
Follow-up
Wave 5
Wave 6
Follow-up
Follow-up
REC
CGMI-V
Follow-up
REC
MT
Follow-up
REC
CGMI-V
Follow-up
REC
MT
Follow-up
Wave 3
Wave 4
Wave 1
Wave 2
REC
REC
CGMI-V
MT
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The purpose of the CGMI-V is to improve ADRD caregivers’ (1) knowledge about late-
stage ADRD; (2) communication and conflict resolution skills, and (3) skills managing 
their loss and chronic grief.  Sessions 1-2 address caregiver knowledge about late-stage 
ADRD, and the resources available to dementia families in the LTCF and the community at 
large.3,28 Sessions 3-4 address caregiver skill in communication and conflict resolution and 
hands-on care in the context of LTCF.3,15-17,28-30 Sessions 5-8 address caregiver loss and 
grief management skills using discussion guides tailored to specific grief management 
topics.31-37 The participant manual outlines each session’s content and includes questions to 
facilitate discussion. Additional materials are provided for knowledge and skill topics. 
These are fact sheets about late-stage ADRD that are published by the Alzheimer’s 
Association, a guide with resources for ADRD family caregivers published by the Family 
Caregiver Alliance, and a chapter on hospice services (Appendix A). 
Control condition. Caregivers in the control condition will receive Minimal Treatment 
(MT) consisting of written information about late-stage ADRD (Alzheimer’s Association) at 
baseline. The Project Director will mail caregivers in the MT control condition all written 
information materials. 
4
SELECTION AND ENROLLMENT OF PARTICIPANTS 
We will recruit a sample of 144 ADRD caregivers who have a family member residing in 
dementia care or memory care units in long-term care facilities located in the Chicago 
metropolitan area. We have well-established collaborating relationships with 35 long-term 
care facilities that will give us access to a diverse pool of approximately 1,000 ADRD 
family caregivers.
4.1
Inclusion Criteria 
Participants must meet all inclusion criteria listed below in order to participate in this study.
•
21 years of age or older
•
Identified as family member, fictive kin (self-identified family member) or 
partner of care recipient at any time post permanent placement of care in 
LTCF
•
Care recipient has a documented ADRD diagnosis and resides in any type of 
unit in a long-term care facility
•
Possessing self-reported basic computer literacy and in-home internet access
•
Able to speak, read, and write English
•
Not currently attending another ADRD caregiver grief management group
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•
 Experiencing high to moderate levels of grief per screening with the Marwit-
Meuser Caregiver Grief Inventory-Short Form (scores 25 or above), and/or 
experiencing high levels of depressive symptoms per screening with PHQ9 
(scores 10 or above)
•
Caregivers whose care recipients die during the course of the intervention will 
remain in the study
4.2
Exclusion Criteria 
All candidates meeting any of the exclusion criteria listed below will be excluded from 
study participation.
•
Younger than 21 years of age
•
Care recipient does not have a documented diagnosis of ADRD;
•
Self-reports a lack of basic computer skills and no internet access.
•
Unable to speak, read, and write English
•
Currently attending an ADRD caregiver grief management group
•
Experiencing low levels of grief per screening with the Marwit-Meuser 
Caregiver Grief Inventory-Short Form (scores below 25), and/or experiencing 
low levels of depressive symptoms per screening with PHQ9 (scores below 
10)
4.3
Study Enrollment Procedures 
Recruitment. Successful recruitment strategies used in our prior studies25-27 will be used. 
These include: (1) a notice describing the study placed in the providers’ monthly newsletters 
distributed to family caregivers at each facility; (2) study flyers and interest forms posted 
around the LTCFs (e.g., front desk, family lounge); (3) individualized letters mailed by the 
facilities’ business office introducing the project to family caregivers of ADRD residents; 
and (4) oral presentations about the project to staff and family caregivers during “family 
night” events. All written and oral communication will use lay language to describe study 
purpose, eligibility criteria, intervention, and data collection methods. All written materials 
will include information about participants’ time commitment and study contact information 
(e-mail address and phone number) that caregivers may use if interested. Interested 
participants will call or e-mail the study office or fill out the interest form, agreeing to be 
contacted by study staff. Completed interest forms will be left in the facility’s front office or 
e-mailed directly to the study e-mail address. 
Consenting. After they contact the study office, caregivers will be scheduled to undergo 
eligibility screening. The Project Director will describe the screening process and the 
instruments used to screen and will ask and document caregivers’ verbal consent to be 
screened for eligibility. Once eligibility is determined, participant caregivers will be 
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informed of the next steps for enrollment in the study. Study staff will use a Web-based 
tracking system, Microsoft Access, to document individual reasons for ineligibility and 
reasons for declining participation in caregivers who met eligibility criteria. Caregivers who 
meet the inclusion criteria will be sent paper or electronic copies of the study informed 
consent form for examination. Within the next 24-48 hours, a telephone appointment with 
the PI or the Project Director will be scheduled to answer any questions caregivers may have 
about the study prior to obtaining informed consent. If agreeable to join the study and 
depending on how they preferred to receive the informed consent forms, caregivers will 
return the signed documents either electronically (e-signature) or in paid, study self-
addressed envelopes. 
Randomization. The study will be implemented in six waves. Beginning in Month 5 of the 
study, we will start recruiting and enrolling 24 eligible caregivers for Wave 1, who will be 
randomly assigned to either the CGMI-V condition (n = 12; 6/group) or MT control 
condition (n = 12) using a randomization software for clinical trials. After these 24 
caregivers have been enrolled, the study team will start recruiting an additional 24 
caregivers for Wave 2. There will be a total of six waves. Each wave will have 8 weeks to 
recruit, screen, and complete baseline data collection, followed by 8 weeks to implement the 
intervention condition, and 24 weeks from baseline follow-up. Once enrollment is 
completed for a wave, recruitment and randomization will start for the following wave. This 
pattern will be the same for all six waves. This will result in 144 caregivers being enrolled, 
72 for the CGMI-V condition, and 72 for the MT control condition (Figure 1). 
5
STUDY INTERVENTIONS 
5.1
Interventions, Administration, and Duration 
The intervention consists of approximately 60-minute sessions delivered weekly for eight 
consecutive weeks and will follow the standardized CGMI-V intervention manual 
(Appendix A). The purpose of the CGMI-V is to improve ADRD caregivers’ (1) knowledge 
about late-stage ADRD; (2) communication and conflict resolution skills, and (3) skills 
managing their loss and chronic grief.  Sessions 1-2 address caregiver knowledge about 
late-stage ADRD, and the resources available to dementia families in the LTCF and the 
community at large.3,28 Sessions 3-4 address caregiver skill in communication and conflict 
resolution and hands-on care in the context of LTCF.3,15-17,28-30 Sessions 5-8 address 
caregiver loss and grief management skills using discussion guides tailored to specific grief 
management topics.31-37 The participant manual outlines each session’s content and 
includes questions to facilitate discussion. Additional materials are provided for knowledge 
and skill topics. These are fact sheets about late-stage ADRD that are published by the 
Alzheimer’s Association, a guide with resources for ADRD family caregivers published by 
the Family Caregiver Alliance, and a chapter on hospice services (Appendix A). Table 1 
illustrates target areas, session title and content, and resources used in each session.
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Control condition. Caregivers in the control condition will receive Minimal Treatment 
(MT) consisting of written information about late-stage ADRD (Alzheimer’s Association) at 
baseline. The Project Director will mail caregivers in the MT control condition all written 
information materials. 
5.2
Handling of Study Interventions 
CGMI-V is a behavioral group-based intervention delivered by trained interventionists who 
have group leading experience. The interventionists will receive an eight-hour training on 
Table 1. CGMI-V Sessions, Target Areas, Content, and Resources
Session/
Week
Session Title
Target Areas
Content
Resources
1
Getting Started
Knowledge
Address ADRD late and 
end-stage changes: physical, 
cognitive, behavioral, 
emotional 
Signs and symptoms 
of late-stage ADRD 
Fact Sheet 
(Alzheimer’s 
Association)
2
What Do You 
Know About This 
Place and the 
Community?
Knowledge
Discuss LTCF philosophy 
of care, structure, 
regulations, policies, and 
personnel roles. Resources 
for the CG and the CR post 
placement in the facility and 
the community at large.
Resources for 
Persons with 
Alzheimer Disease; 
When to Seek 
Hospice Care 
(Reynolds, S.)
3
How Do I Get 
My Message 
Through?
Communication/Conflict-
Resolution Skills
Practice conflict-resolution 
techniques with LTCF staff, 
CR, other residents, and 
their family members
Communication 
(Alzheimer’s 
Association)
4
Doing for and 
Working with My 
Loved One
Hands-on Care Skills
Discuss hands-on care for 
CR and participation in 
LTCF activities
Resources and 
Information Kit-
Caregiver Tips 
(Family Caregiver 
Alliance)
5
Losses and 
Separation
Grief Management Skills
Recognize losses and 
process reaction to 
separation 
Discussion guide in 
participant manual
6
What Defined 
Our 
Relationship?
Grief Management Skills
Recollect and re-experience 
the relationship with the CR
Discussion guide in 
participant manual
7
How Do I Let Go 
and Readjust?
Grief Management Skills
Process relinquishing old 
attachments and 
assumptions; process 
readjusting to the new 
without forgetting the old
Discussion guide in 
participant manual
8
Life Goes On
Grief Management Skills
Discuss reinvesting in new 
attachments, goals; process 
group closure
Discussion guide in 
participant manual
ADRD = Alzheimer and related diseases; CG = caregiver; CR = care recipient; LTCF = LTCF facility
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intervention delivery and technology use (Appendix B).
5.3
Concomitant Interventions
5.3.1
Allowed Interventions
Participants in this group-based study may attend other informal ADRD caregiver 
support groups.
5.3.2
Required Interventions 
There are no concomitant required interventions for this study.
5.3.3
 Prohibited Interventions
Participants will be excluded if already attending an ADRD caregiver chronic grief 
management support group.
5.4
Adherence Assessment: 
We will use a Web-based tracking system, Microsoft Access, to assess the receipt of the 
dose consisting of eight group sessions. We will calculate attendance rates for each 
participant and record reasons for missing sessions. We will assess enactment of the 
CGMI-V intervention with specific items in an anonymous participant survey administered 
at 8 and 24 weeks (e.g., “Since our last assessment meeting, how often have you used: 
communication skills and conflict resolution techniques learned in the program when 
interacting with facility staff?”)
6
STUDY PROCEDURES
Study procedures are outlined on the following pages.
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6.1
Schedule of Evaluations
Assessment
Eligibility 
Screening
(phone/online 
interview)
Enrollment 
/Randomization 
Baseline 
(phone/online 
interview) 
8-weeks post baseline 
(phone/on
line interview
24-weeks post baseline 
(phone/on
line interview
Eligibility Screening Verbal 
Consent
X
 
 
 
 
Inclusion/Exclusion Criteria
X
 
 
 
 
Study Informed Consent Signed
X 
 
 
 
Caregiver/Care Recipient  Socio-
demographics 
 
X
 
 
Caregiver/Care Recipient 
Situational Characteristics
X
 
 
Caregiver Chronic Grief
X
X 
 X
Caregiver Depressive Symptoms
X
X 
X
Caregiver Anxiety Symptoms
X
X
X
Caregiver Positive States of Mind
X
X 
X
Conflict with Facility Staff
X
X
X
Satisfaction with Care 
 
X 
X 
X 
Caregiver Knowledge of ADRD
 
X 
X 
X 
Caregiver Sense of Loss
 
 
X
X
X
Caregiver Guilt
 
X
X
X
Caregiver Role Captivity
X
X
X
Caregiver Adherence to CGMI-V 
Survey (Satisfaction Survey)
X
X
Change in status survey (CG/CR)
X
X

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6.2
Description of Evaluations 
Study evaluations consist of: (1) eligibility screening for inclusion criteria, (2) Baseline 
assessment immediately after enrollment, (3) 8-weeks post-baseline, for intervention 
effects, and (4) 24-weeks post-baseline for maintenance effects.
6.2.1
Screening Evaluation
Consenting Procedure
The Project Director will schedule a phone or online screening interview with 
caregivers expressing an interest in the study. The Project Director will explain the 
screening process and the questionnaires used to ascertain participant eligibility and 
invite any caregiver questions. After all questions are addressed, verbal consent to 
screening will be documented after the screener explicitly asks the caregivers if they 
consent. 
Screening  
Caregivers who verbally consent will be screened using computer-assisted telephone 
interviewing (CATI) for the following inclusion criteria:
•
21 years of age or older
•
Identified as family member, fictive kin (self-identified family member) or 
partner of care recipient
•
Within the first two years of care recipient’s permanent placement in a long-
term care facility (LTCF)
•
Care recipient is a resident in a dementia or memory care unit in the LTCF, 
where a diagnosis of ADRD is mandatory
•
Possessing self-reported basic computer literacy and in-home internet access
•
Able to speak, read, and write English
•
Not currently attending another ADRD caregiver grief management group
•
 Experiencing high to moderate levels of grief per screening with the Marwit-
Meuser Caregiver Grief Inventory-Short Form38 (scores 25 or above), and/or 
experiencing high levels of depressive symptoms per screening with PHQ939 
(scores 10 or above)
Caregivers meeting all eligibility criteria will be sent a consent form including 
detailed information about the study. A phone or online meeting will be scheduled 
with the PI or the Project Director within the next 24-48 hours for discussion of study, 
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content of consent form, and to respond to any other questions. 
Enrollment 
Participants will be enrolled into the study once their signed study informed consents 
are being returned to study office. A baseline appointment will be scheduled within 
the next 24-48 hours.  
Baseline Assessments
Participants who are enrolled into the study, will be assessed at baseline using CATI, 
for the following outcomes:
•
Caregiver and care recipient socio demographics
•
Caregiver and care recipient situational characteristics
•
Caregiver grief
•
Caregiver depressive symptoms
•
Caregiver anxiety symptoms
•
Caregiver positive states of mind
•
Caregiver conflict with facility staff
•
Caregiver satisfaction with care in the facility
•
Caregiver knowledge of ADRD
•
Caregiver sense of loss
•
Caregiver guilt
•
Caregiver role captivity
Randomization
The study will be implemented in six waves. Beginning in Month 5 of the study, we 
will start recruiting and enrolling 24 caregivers for Wave 1, who will be randomly 
assigned to either the CGMI-V condition (n = 12; 6/group) or MT control condition (n = 
12). After these 24 caregivers have been enrolled, the study team will start recruiting 
and enrolling an additional 24 caregivers for Wave 2. There will be a total of six waves. 
Each wave will have 8 weeks to recruit, screen, enroll, randomize to condition, and 
complete baseline data collection, followed by CGMI-V implementation over 8 
consecutive weeks (Figure 1).
6.2.2
Follow-up Assessment: Immediately Post-intervention (8 weeks from baseline)
This study will not use follow-up visits. All follow-up evaluations will be performed 
using computer-assisted telephone interviewing (CATI). The following study 
outcomes will be measured within 24-48 hours from intervention completion for 
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intervention effects:
•
Caregiver grief
•
Caregiver depressive symptoms
•
Caregiver anxiety symptoms
•
Caregiver positive states of mind
•
Caregiver conflict with facility staff
•
Caregiver satisfaction with care in the facility
•
Caregiver knowledge of ADRD
•
Caregiver sense of loss
•
Caregiver guilt
•
Caregiver role captivity
•
Caregiver adherence to CGMI-V/Satisfaction Survey (intervention condition)
•
Changes in caregiver and care recipient status
6.2.3
Completion/Final Evaluation (24 weeks from baseline)
This study will not use a final visit. All Completion/Final evaluations will be 
performed using computer-assisted telephone interviewing (CATI). The following 
study outcomes will be measured at 24 weeks from baseline for maintenance effects:
•
Caregiver grief
•
Caregiver depressive symptoms
•
Caregiver anxiety symptoms
•
Caregiver positive states of mind
•
Caregiver conflict with facility staff
•
Caregiver satisfaction with care in the facility
•
Caregiver knowledge of ADRD
•
Caregiver sense of loss
•
Caregiver guilt
•
Caregiver role captivity
•
Caregiver adherence to CGMI-V /Satisfaction Survey (intervention condition)
•
Changes in caregiver and care recipient status
Based on our previous pilot studies25-27, we do not anticipate early termination of the 
CGMI-V study. We will document reasons for participant voluntary drop-out and will 
ask participants who may have dropped out prior to completing the 8 group-based 
CGMI-V sessions to participate in the 8 and 24-week follow-up assessments. 
7
SAFETY ASSESSMENTS 
Participant safety will be monitored once each individual is screened and enrolled in the 
study. CGMI-V is a low risk behavioral intervention designed to support ADRD 
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caregivers emotionally in the context of placement of a family member with ADRD in a 
long-term care facility. The proposed intervention poses minimal risk to participants. 
During screening and data collection for both conditions, there is potential risk for 
caregivers to disclose:
•
Depressive symptoms (high levels indicative of clinical depression)
•
Suicidal ideation
During the Chronic Grief Management Intervention-Video (CGMI-V) intervention 
implementation, emotional upset may occur especially during the last four sessions, 
when grief processing becomes the focus of the intervention. Caregivers may disclose 
high levels of: 
•
Depressive symptoms (high levels indicative of clinical depression)
•
Suicidal ideation
7.1
Specification of Safety Parameters
•
A score greater than16 points (indicative of risk for clinical depression) on the 
Center for Epidemiological Studies-Depression Scale (CES-D)40 
•
A score >1 on the PHQ 9 suicidal assessment item: “Thoughts that you would be 
better off dead or of hurting yourself” 
•
Verbalizing suicidal ideation during CGMI-V group session intervention 
implementation
7.2
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters
CGMI-V is a low risk behavioral intervention designed to support ADRD caregivers 
emotionally within the first two years of placement of a family member with ADRD in a 
long-term care facility. The proposed intervention poses minimal risk to participants. 
Identified safety parameters identified above in 7.1 will be assessed at: pre-enrollment 
screening, and the three data collection points (baseline and 8 and 24-weeks). 
Interventionists will implement suicide protocol in the event of reported suicidal ideation 
during group sessions.
7.3
Adverse Events and Serious Adverse Events 
An adverse event (AE) is generally defined as any unfavorable and unintended diagnosis, 
symptom, sign (including an abnormal laboratory finding), syndrome or disease which either 
occurs during the study, having been absent at baseline, or if present at baseline, appears to 
worsen. An example of an Adverse Event (AE) anticipated for this study would be, during 
data collection, a Center for Epidemiological Studies-Depression Scale (CES-D) score 
greater than16 points, indicative of risk for clinical depression. Whether or not this high 
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score is associated with study participation, we will monitor and report it as an AE, per 
protocol.
A serious adverse event (SAE) is generally defined as any untoward medical occurrence 
that results in death, is life threatening, requires inpatient hospitalization or prolongation of 
existing hospitalization, results in persistent or significant disability/incapacity, or is a 
congenital anomaly. An example of a Serious Adverse Event (SAE) anticipated for this 
study would be a participant’s endorsement of suicidal ideation when screened with the 
PHQ-9 or disclosing suicidal ideation in a group session. Whether or not associated with 
study participation, we will monitor and report suicidal ideation or intention as a SAE, per 
protocol adopted from the Office of the Human Research Protection Program’s Research 
Protocols and Risk of Suicide Guidelines (2012).
An Unanticipated Problem (UP) for this study would be any study participant incident, 
experience or outcomes that are unexpected in severity or frequency suggesting that 
participants are at greater risk of harm than anticipated. An example of an Unanticipated 
Problem (UP) for this study would be a participant becoming extremely upset with 
intervention content, to the point of dropping off from the study as a consequence. Whether 
or not associated with study participation, we will monitor and report per protocol. 
7.4
Reporting Procedures
The PI will use standardized NIA forms to report all adverse effects (AEs) and serious 
adverse effects (SAEs) (except death) in writing to the NIA Program Officer (PO), Safety 
Officer (SO) and Rush University IRB on a quarterly basis. 
Any Unanticipated SAEs not listed in the Data Safety Monitoring Plan related to the 
intervention will be reported by the PI on an expedited basis within 48 hours from 
determination of occurrence to the NIA PO, SO, and IRB, following–up with a written 
corrective plan with measures to prevent reoccurrence. 
The PI will report any participant death whether or not related to study participation and 
regardless of intervention condition to NIA PO, SO, and IRB on an expedited basis within 
24 hours from determination of occurrence. 
Unanticipated problems including other incidents, outcomes, or experiences that are not 
SAEs (e.g. data breach, confidentiality threat) will be reported by the PI using standardized 
forms to NIA PO, SO, and IRB within 48 hours, including a corrective plan and measures to 
prevent reoccurrence. .
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7.5
Follow-up for Adverse Events
Participants experiencing AEs will be referred for outpatient or inpatient treatment 
(depending on severity). Follow-up will span the 24-week duration of the study 
participation.
7.6
Safety Monitoring
The Principal Investigator (PI) will be responsible for ensuring participant and data safety 
on a daily basis. As a Stage I, single site, and minimal risk study, we will establish an 
internal committee to assist with data safety monitoring (DSM). In addition, an NIA-
approved Safety Officer (SO) will oversee the DSM, and will review data and adverse 
events twice per year and more frequently if necessary. The SO will act in an advisory 
capacity to the NIA Director and PO to monitor participant safety, evaluate the progress of 
the study, and to review procedures for maintaining the confidentiality of data, the quality 
of data collection, management, and analyses. 
8
INTERVENTION DISCONTINUATION 
CGMI-V is a Stage I, single site, minimal risk behavioral intervention study. There is no 
anticipated intervention discontinuation for this study. Study participants may withdraw 
voluntarily from participation in the study at any time and for any reason. We will continue 
to follow these participants, with their permission, at the 8 and 24 week assessment points. 
Participants in the CGMI-V condition who discontinue early will not be replaced, as this is a 
group-based intervention where “the dose” consists of eight consecutive weekly group 
sessions.
9
STATISTICAL CONSIDERATIONS 
9.1
General Design Issues 
CGMI-V is a Stage I longitudinal randomized clinical trial. ADRD caregivers whose 
family members are in long-term care facilities (LTCFs) will be recruited, screened for 
inclusion criteria, and randomly assigned to either CGMI-V or a Minimal Treatment (MT) 
control condition. Caregivers in the CGMI-V condition will participate in eight weekly 
professionally led, real-time, live-streaming video online group sessions. Those caregivers 
in the MT control condition will receive written information materials about late-stage 
ADRD at baseline. For both conditions, data will be collected at baseline (pre-
intervention), 8 weeks (immediately post-intervention) for intervention effects, and 24 
weeks post baseline for maintenance effects. The design for this study was chosen to avoid 
the type of group clustering or contamination that would be engendered by the use of a 
randomized cluster design. The study hypotheses are outlined below:
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Primary Hypothesis
Hypothesis 1: We hypothesize that caregivers in the CGMI-V condition compared to those 
in the MT control condition, will report decreased chronic grief levels.
Secondary Hypotheses
Hypothesis 2: We hypothesize that caregivers in the CGMI-V condition compared to those 
in the MT control group will report (2.1) decreased symptoms of depression and anxiety and 
(2.2) increased positive mental states. 
Hypothesis 3.1 and 3.2:  We hypothesize that caregivers in the CGMI-V condition compared 
to those in the MT control condition will report (3.1) increased satisfaction with care 
provided in the facility and (3.2) decreased conflict with staff. 
Mechanism of Intervention Hypothesis 
Hypothesis 4: We hypothesize that CGMI-V works by changing the exacerbators of chronic 
grief: lack of knowledge, sense of loss, guilt, and role captivity.
Primary Outcome Measures 
Caregiver Chronic Grief will be measured with the 50-item Marwit-Meuser Caregiver Grief 
Inventory (MM-CGI).6 This inventory has three subscales: (1) Personal Sacrifice Burden: 18 
items measuring individual losses experienced as a result of caregiving, (2) Heartfelt Sadness 
and Longing: 15 items measuring interpersonal emotional reactions in response to 
caregiving, and (3) Worry and Felt Isolation: 17 items measuring feelings of losing 
connections with, and support from, others. Items are rated on a 5-point scale (1 = strongly 
disagree to 5 = strongly agree), with a possible range of 50 to 250 points. Grief scores may 
be calculated by subscale and then added to formulate a total grief score. Total grief scores 
above 175 indicate high levels of caregiver grief, requiring formal intervention and support. 
Cronbach’s alpha subscale scores range from .90 to .96, indicating high internal consistency 
reliability for each subscale and for their combined total grief score. Test-retest Cronbach’s 
alpha scores range from .71 to .75, indicating stability of the measure over time in all three 
subscales.15 
Secondary Outcomes Measures
Depressive symptoms will be measured with the 20-item version of The Center for 
Epidemiological Studies Depression Scale (CES-D).40 Responses are based on a four-point 
frequency rating (0 = rarely or none of the time to 3 = all of the time), with a possible range 
of 0 to 60. A score above 16 indicates existence of depressive symptoms. Internal 
consistency reliability range r =.85 to .90, and test-retest reliability r = .45 to .70.40 
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Anxiety symptoms will be measured with the 20-item State-Anxiety subscale of the State-
Trait Anxiety Inventory (STAI).41 Responses are based on a scale of 1 to 4 (1 = almost never 
to 4 = almost always), with a possible range of 20-80, where higher scores indicate greater 
anxiety. Alpha coefficients for older adults range .90-.92, indicating high internal consistency 
reliability.41 
Positive States of Mind will be measured with the Positive States of Mind Scale (PSOMS)42 
to assess the extent to which caregivers were able to achieve six positive states of mind in the 
previous seven days. Other studies21 found that caregivers who scored high on the PSOMS 
also scored lower on the grief scale. The scale comprises six items that capture: (1) focused 
attention, (2) productivity, (3) responsible caregiving, (4) restful repose, (5) sensuous 
nonsexual pleasure, and (6) sharing. The responses range from 0 = unable to achieve to 3 = 
easy to achieve. Cronbach’s alpha coefficient was .77, indicating high internal consistency 
reliability. 
Conflict with facility staff will be measured with a subscale of the Family Perception of 
Caregiving Role (FPCR). The 61-item FPCR3,30 contains four subscales to measure 
dimensions of role stress: (1) loss of relationship aspects with care recipient, (2) guilt from 
perceived failure in caregiving, (3) captivity resulting from obligations of caregiving, and (4) 
conflict with facility staff related to caregiving. Responses are rated on a 7-point Likert scale 
(1 = strongly disagree to 7 = strongly agree), with a possible range of 61 to 427. Items are 
summed to form subscale scores and a total FPCR score. Cronbach’s alpha coefficients 
ranging from .70 to .84 indicate high internal consistency reliability for each subscale and for 
the total FPCR score. Test-retest reliability was .79 for FPCR total score.3,30 We will score 
the 10-item Conflict with Facility Staff subscale; its Cronbach’s alpha coefficient is .84. 
Satisfaction with care will be measured with the Family Perceptions of Care Tool (FPCT).3.30 
The 51-item FPCT contains four subscales that reflect caregivers’ perceived satisfaction 
with: (1) physical care provided to their family member in the facility, (2) activities for 
facility residents, (3) unit management, and (4) staff consideration for resident and family 
member. Responses are rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly 
agree), with a possible range of 51 to 357. Items are summed to form subscale scores and a 
total FPCT score. Cronbach’s alpha coefficients ranging from .85 to .97 indicate high internal 
consistency reliability for each subscale and for the total FPCT score. We will use all 51 
items to assess caregiver satisfaction with care received in the LTCF.3.30 
Exacerbators of Chronic Grief 
We will measure four exacerbators of ADRD caregiver chronic grief: (1) caregiver lack of 
knowledge about dementia, (2) caregiver perception of loss, (3) guilt, and (4) role captivity. 
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Knowledge of dementia/AD will be measured with the 22-item Family Knowledge of 
Alzheimer’s Test (FKAT).30 This instrument captures what a family caregiver knows about 
the disease process, how the care recipient is behaving, and how the LCTF is caring for him 
or her. Responses are based on a true/false scale, with a maximum score of 22 correct 
answers. Test-retest reliability was .82 (p < .05), KR 21 (n = 50) = .61. 
Loss will be measured with the 7-item Loss subscale of the FPCR3,30 (full description above). 
Cronbach’s alpha for this subscale was 0.73. 
Guilt will be measured with the 5-item Guilt subscale of the FPCR3,30 (full description 
above). Cronbach’s alpha for this subscale was 0.70. 
Role captivity will be measured with the 7-item Captivity subscale of the FPCR3,30 (full 
description above). Cronbach’s alpha for this subscale was 0.81. 
Background Measures
Caregiver and care recipient socio-demographics. To describe caregiver and care recipient 
baseline background data, we will collect standardized information. These survey questions 
are drawn from the initial population survey used by the East Boston site for the Established 
Populations for Epidemiologic Studies of the Elderly project (EPES).43 Situational 
characteristics. Three direct questions will be asked at baseline to assess: (1) number of years 
since the care recipient was diagnosed with ADRD, (2) time since placement in the LTCF, 
and (3) visiting pattern in the LTCF (times per week and number of hours per visit).
9.2
Sample Size and Randomization
Precision analysis. Because we are estimating an effect size, rather than a p value, we are 
primarily concerned with precision of estimation rather than power. The standard deviation 
associated with total grief as measured with the MM-CGI is around 35.78 raw units. Thus, 
a change of one SD represents a two-thirds of a unit change in the MM-CGI Likert Scale. If 
we obtain a sample of 64 participants per condition, our standard error of measurement 
(SEM) around this effect size estimate will be about 4.47 units, producing confidence 
intervals between -8.77 and +8.77 units. This will allow us to estimate a Cohen’s d within 
.25 SD units of the actual value, a reasonably robust estimate, 95% of the time. Adjusting 
for a 10% attrition rate, we will collect a total sample of 72 participants per condition (a 
total of 144 participants).57 
9.2.1
Treatment Assignment Procedures
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The study is a Stage I longitudinal randomized clinical trial. ADRD caregivers whose 
family members are in LCTFs will be recruited, screened for inclusion criteria, and 
randomly assigned to either CGMI-V or a Minimal Treatment (MT) control condition.  
Randomization will be stratified in six Waves of 24 participants each, to insure that 
there are exactly 12 participants in each condition. In Wave 1, we will randomly assign 
the first 24 enrolled participants to either the CGMI-V condition (n = 12; 6/group) or 
MT control condition (n = 12). The same process will continue for the next five Waves. 
Recruiters and data collectors will be blinded as to the random assignment of each 
participant. Once caregivers sign the consent to enroll in the study, the Project Director 
will use randomization software to assign each enrolled participant to CGMI-V or the 
MT condition. The Project Director will then inform the participants directly of their 
assignments and ask them to maintain confidentiality about their assignment at data 
collection points.
9.3
Interim analyses and Stopping Rules
There are no planned interim analyses, as this is a low risk, Stage 1 clinical trial. Interim 
analyses will only occur if there is a requirement from the Safety Officer in response to 
specific participant safety issues surrounding the study.  
9.4
Outcomes 
Multilevel modeling will be used to examine effect sizes associated with both the 
primary and secondary outcomes. All primary and secondary outcomes will be 
measured at Baseline, 8 weeks, and 24 weeks. 
9.4.1
Primary outcome: Chronic Grief  
Caregiver Chronic Grief will be measured with the 50-item Marwit-Meuser Caregiver 
Grief Inventory (MM-CGI).
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9.4.2
Secondary outcomes: 
Depressive Symptoms will be measured with the 20-item Center for Epidemiological 
Studies Depression Scale (CES-D). 
Anxiety Symptoms will be measured with the 20-item State-Anxiety subscale of the 
State-Trait Anxiety Inventory (STAI).
Positive States of Mind will be measured with the 6-item Positive States of Mind 
Scale (PSOMS).
Conflict with Facility Staff will be measured with the 10-item Conflict with Facility 
Staff subscale of the Family Perception of Caregiving Role (FPCR).
Satisfaction with Care will be measured with the 51-item Family Perceptions of Care 
Tool (FPCT).
9.5
Data Analyses 
We will track all study participants following CONSORT guidelines and enter all data 
into a REDCap database. SPSS for Windows (Version 22) and R (Version 3.1.1) will be 
used for data management and statistical analysis. A two-tailed 0.05 significance level 
will be used for all statistical tests except where noted below. All analyses will be 
performed on an intent-to-treat basis. Missing data will be imputed using the R mi 
package, a multiple imputation computer program based on the work of Rubin. 
Histograms will be obtained for these variables, and skew and kurtosis will be assessed 
to assess statistical normality. From previous research, we expect the error rates to have 
statistically normal distributions or distributions that can be transformed to normality 
using logarithmic and square root transformations. We will perform any necessary 
transformations using Tukey’s ladder of transformation before conducting statistical 
analysis. Because these trials are designed to estimate precise effect sizes rather than 
probability values, the results of each trial will be the effect size (comparing treatment 
and control groups) and confidence intervals around this estimate. 
Aim 1. Controlling for background variables, establish effect sizes of the CGMI-V 
condition and Minimal Treatment (MT) control condition on changes in a primary 
caregiver chronic grief outcome.
Multilevel linear models will be run for the CGMI-V and MT control conditions. 
Multilevel models are used to estimate autocorrelation across the three time points. We 
hypothesize that chronic grief will decrease more in the CGMI-V condition relative to 
the MT control condition. Caregiver sex, age, relationship to the care-receiver, as well 
as care recipient death or discharge from the facility, will be controlled for as covariates 
in the analysis. Sex and caregiver/care recipient relationship, as well as care recipient 
death or discharge from the facility, will be entered into the model as dummy-coded 
variables. We will examine the interaction effects (δ) to make certain that they are large 
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enough to justify a more robust clinical trial. While there is some likelihood of 
obtaining significant findings in this study, the primary purpose of this analysis is to 
estimate effect sizes.
Aim 2. Controlling for background variables, compare the effect sizes of the CGMI-V 
condition and MT control condition on changes in secondary caregiver mental health 
outcomes: depression symptoms and anxiety symptoms and positive states of mind. We 
hypothesize that one dependent measure (positive states of mind) will increase more 
and the other two (depression symptoms and anxiety symptoms) will decrease more in 
the CGMI-V group relative to the MT control condition. 
Apart from the dependent measures examined, this analysis will parallel that described 
in Aim 1. As in Aim 1, the primary goal of this analysis is to estimate effect sizes 
associated with the CGMI-V. 
Aim 3. Controlling for background variables, compare the effect sizes of the CGMI-V 
condition and MT control condition on secondary facility-related outcomes: caregiver 
satisfaction with care and conflict with staff in the LTCF. We hypothesize that caregiver 
satisfaction with care will increase and that conflict with staff in the LTCF will decrease 
in the CGMI-V condition relative to the MT control condition. 
Apart from the dependent measures examined, this analysis will also parallel that 
described in Aim 1. As in Aim 1, the primary goal of this analysis is to estimate effect 
sizes associated with the CGMI-V. 
Aim 4. Examine the mediating effects of chronic grief exacerbators on chronic grief, 
mental health, and facility-related outcomes. We hypothesize that improvement in 
chronic grief exacerbators will mediate the improvements in caregiver chronic grief, 
mental health, and facility-related outcomes. 
The focus of the proposed study is on change in chronic grief, mental health, and 
facility-related outcomes between measurement points and change in chronic grief 
exacerbators as a mediating variable. Thus, we propose to use residualized change 
scores (i.e., the difference between the observed score of a variable and the predicted 
score based on the baseline measure of that variable) throughout the analyses. These 
scores have the advantage of evaluating change between measurement points without 
concerns about regression toward the mean that are associated with standard change 
scores and have the advantage of reducing the number of variables in the model. In 
general, the analytic model will include covariates to control for background 
characteristics of the participants and time since baseline. The mediation effects of 
changes in chronic grief exacerbators (lack of knowledge, sense of loss, guilt, and role 
captivity) on three outcome measures (chronic grief, mental health, and facility-related 
outcomes) will be examined in three separate models. The regression mediation models 
described in MacKinnon76 will be used to estimate these effects. The null hypothesis is 
that changes in chronic grief exacerbators will not mediate any of the three outcome 
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measures. As mentioned in the first three aims, the primary goal of this analysis is to 
estimate the size of these mediation effects, rather than to obtain statistically significant 
differences. 
In accordance with NIH policy we will perform an analysis to estimate effect sizes 
associated with CGMI-V intervention between gender and racial/ethnic subgroups.
10
DATA COLLECTION AND QUALITY ASSURANCE
10.1 Data Collection Forms
Trained Research Assistants (RAs) blinded to treatment condition will use Computer-
assisted Telephone Interviewing (CATI) to complete all initial screening and data 
collection interviews. Study RAs will read each question and enter the response directly 
into the secure, web-based Research Electronic Data Capture (REDCap).
10.2 Data Management 
The Project Director will coordinate and closely monitor all day-to-day operations related 
to data collection and management.  The Project Director will schedule and track all data 
collection appointments, monitor, and document missed appointments. 
The study Data Manager will set up and manage data using CONSORT and the Microsoft 
Access tracking program, will set up data collection forms in REDCap, and will clean 
data.
The study Statistician will develop a coding manual, will oversee quality of data coding 
and computer entry, will track subject attrition, and will program for specific statistical 
procedures.
All outcomes measurement instruments will be set up as data collection forms in 
REDCap.
10.3 Quality Assurance 
10.3.1
Training
The PI and one co-I or the project Director will provide Research Assistants (RAs) 
who will collect data for this study with an initial manualized 8-hour training 
consisting of an overview of the study, a thorough review of the measurement 
instruments including role playing data collection using study instruments, and 
orientation to inputting data using REDCap (Appendix C). 
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RAs will be trained in being sensitive to participants’ needs during data collection 
and how to respond to participants who score high on the depression scale and/or 
indicate risk of suicide using a safety protocol. 
The PI and/or co-I/Project Director will hold regular monthly meetings with all RAs 
to address any issues related to data collection.
10.3.2 Metrics
To verify accuracy of test administration, the Project Director will compare three 
randomly selected samples of baseline assessments from each treatment condition, 
will discuss inconsistencies/missed items with the data collectors and will correct any 
potential differences in test administration. 
The study Data Manager will ensure that data is correctly inputted into REDCap and 
will provide immediate feedback to the PI if any irregularities are noticed.
10.3.3 Protocol Deviations
RAs will be trained to report any protocol deviations as they occur. The Project 
Director will document the protocol deviation and a meeting with the PI and the RA 
in question will be scheduled within 24-48 hours from occurrence to review the 
deviation and determine a plan of action for remediation.
10.3.4 Monitoring
The data will be examined yearly. The items to be monitored are: adverse events, 
attrition rate, reasons for dropping out of the study, and group session attendance 
rates. Ongoing attention will be given to participant recruitment, accrual and 
retention, follow-up, flow of data forms, protocol adherence, and quality of data. 
Special attention will be given to participant safety, including ongoing assessment of 
potential adverse effects and the magnitude of their impact on participants. The PI 
will assume major responsibility to perform the data and safety monitoring function 
on an ongoing basis. Data collectors (RAs) will be required to meet every month with 
the Project Director and the PI throughout the duration of the research project to 
address any ongoing instrument use and data collection issues. The Project Director 
will be present with each RA to the first assessment and will randomly select 3 
baseline assessments from each treatment condition to check for missed items and/or 
inconsistencies. The Data Safety Monitoring Committee will report to the PI within 
10 days of the meeting. If the DSMC recommends suspension of the study, the Rush 
IRB will be notified within 5 days from the determination. All data collection 
procedures will be reviewed every 4-6 months. All revisions/changes will be 
documented in the meeting minutes.
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11
PARTICIPANT RIGHTS AND CONFIDENTIALITY 
11.1 Institutional Review Board (IRB) Review
This protocol and the informed consent document (Appendix D) and any subsequent 
modifications will be reviewed and approved by the Rush University IRB committee 
responsible for oversight of the study.  
11.2 Informed Consent Forms
All written and oral communication will use lay language to describe study purpose, 
eligibility criteria, intervention, and data collection methods. All written materials will 
include information about participants’ time commitment and study contact information 
(e-mail address and phone number) that caregivers may use if interested. Interested 
participants will call or e-mail the study office or fill out the interest form, agreeing to be 
contacted by study staff. These forms will be left in the facility’s front office or e-mailed 
directly to the study e-mail address. After they contact the study office, caregivers who 
meet the inclusion criteria will be sent paper or electronic copies of the informed consent 
and HIPAA forms for examination. Within the next 24-48 hour, a telephone appointment 
with the PI or the Project Director will be scheduled to answer any questions caregivers 
may have about the study prior to obtaining informed consent. If agreeable to join the 
study, and depending on how they preferred to receive the forms, caregivers will return 
the signed documents either electronically (e-signature) or in paid, study self-addressed 
envelopes. Recruitment will be overseen by the PI and the Project Director. In facilities 
with African American residents, recruitment will be overseen by Dr. Inventor (Co-I), 
who has expertise in recruitment of participants of diverse backgrounds.
A signed consent form will be obtained from each participant. The consent form will 
describe the purpose of the study, the procedures to be followed, and the risks and 
benefits of participation. A copy will be given to each participant and this fact will be 
documented in the participant’s record. 
11.3 Participant Confidentiality 
To protect against privacy risks associated with the use of WebEx live streaming video to 
deliver the interventions we will take the following measures: 1) each caregiver will use a 
unique password-protected iPad to access WebEx, 2) each group of caregivers will use a 
unique password-protected link to access the online sessions for their individual group, 3) 
caregivers will be strongly encouraged to use the iPads strictly for study purposes and not 
share their passwords with anyone else, 4) iPads will be checked and reset with a new 
password when passed to a new set of caregivers, and 5) the recorded audio and video 
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sessions will remain password protected and only relevant study personnel (PI, Co-Is, 
interventionists) will have access to them for fidelity and quality control purposes.
Any data, forms, reports, recordings, and other records that leave the site will be 
identified only by a participant identification number (Participant ID/PID) to maintain 
confidentiality.  All written records will be kept in a locked file cabinet.  All computer 
entry and networking programs will be done using PIDs only. Information will not be 
released without written permission of the participant, except as necessary for monitoring 
by IRB, the NIA, and the OHRP.
11.4 Study Discontinuation 
The study may be discontinued at any time by the IRB, the NIA, the OHRP or other 
government agencies as part of their duties to ensure that research participants are 
protected. 
12
	
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The following NIH ethical principles guide the CGMI-V study: (1) social and clinical 
value, (2) scientific validity, (3) fair subject selection, (4) favorable risk-benefit ratio, (5) 
independent review, (6) informed consent, and (7) respect for potential and enrolled 
subjects. In practice, we enact these principles in the following ways:
1) We seek to establish effect sizes for the CGMI-video intervention on chronic grief in 
caregivers of persons diagnosed with ADRD who were placed in long-term care facilities 
LTCFs). Chronic grief can contribute to mental health problems in family caregivers, 
such as anxiety, depression, and suicidality.5-8,22 Moreover, family caregiver grief and its 
exacerbators (lack of knowledge, sense of loss and guilt, and caregiver role captivity) can 
provoke dissatisfaction with care provided in the LTCFs and increase conflict with staff. 
3,11,12 Although placement exacerbates family caregivers’ grief, LTCF do not provide 
families with grief-focused support specific to this transition.12,24 Thus, there is a critical 
need for post-LTCF-placement grief interventions for ADRD caregivers whose family 
members are in LTCF.
2) We were unable to find any existing post-placement, online group interventions for 
ADRD caregivers. Therefore, we pilot-tested a professionally led, post-placement, live-
streaming video, online group intervention: the CGMI-Video. For the CGMI-V pilot, 
retention was high (100%), and caregivers expressed satisfaction with the method of 
delivery, leading us to develop CGMI-V in a Stage I randomized clinical trial. 
3) We will recruit participants who have a family member residing in one of 35 facilities 
located in the Chicago metropolitan area that have dementia care and/or memory care 
units owned by two for-profit LTCF providers. We have access to a pool of family 
caregivers of more than 1,000 residents diagnosed with ADRD. We have well-established 
collaborating relationships with these facilities, as we have recruited from them for our 
preliminary studies.
4) The intervention poses minimal risks to participants. The benefits of acquiring new 
knowledge about late-stage dementia and AD, practicing communication and conflict 
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resolution skills, along with processing loss and chronic grief, are very likely to outweigh 
potential risks. Risks during data collection are mitigated by enacting our study safety 
protocol, and risks related to the online video platform are mitigated by multiple layers of 
password protection.
5) This protocol and the informed consent document and any subsequent modifications 
will be reviewed and approved by the Rush University IRB committee responsible for 
oversight of the study. The PI will use standardized NIA forms to report all adverse 
effects (AEs) and serious adverse effects (SAEs) (except death) in writing to the NIA 
Program Officer (PO), Safety Officer (SO) and Rush University IRB on a quarterly 
basis. The PI will report any participant death whether or not related to study 
participation and regardless of intervention condition to NIA PO, SO, and IRB on an 
expedited basis within 24 hours from determination of occurrence. Unanticipated 
problems including other incidents, outcomes, or experiences that are not SAEs (e.g. data 
breach, confidentiality threat) will be reported by the PI using standardized forms to NIA 
PO, SO, and IRB within 48 hours, including a corrective plan and measures to prevent 
reoccurrence.
6) The study informed consent outlines the purpose of the study, provides information 
regarding rights of study participants, outlines study procedures, and communicates 
information concerning confidentiality and the voluntary nature of study participation. 
Participants will be informed that they may withdraw from the study at any time without 
jeopardizing theirs’ or their family members’ access to care in the facility where the study 
is being conducted.
7) We ensure respect for participants and potential participants by adhering to our 
informed consent outlines, following all data safety monitoring protocol, and protecting 
the confidentiality of participants and potential participants.
13
COMMITTEES
As a Stage I, single site, and minimal risk study, we will establish an internal committee to assist 
with data safety monitoring (DSM). Drs. Susan Buchholz and Lisa Barnes will serve as members 
independent of the study team. Dr. Buchholz is a Professor in the Department of Adult Health 
and Gerontological Nursing and has extensive clinical (Advanced Nurse Practitioner) and 
research experience with geriatric populations. Dr. Barnes is a Professor and Cognitive 
Neuropsychologist at the Rush University Medical College. Dr. Barnes has served on the DSM 
Internal Committee for our NIH-funded pilot study (R21NR010577) and is familiar with the PI’s 
work with ADRD caregiver grief. In addition, the following members of the research team will 
serve on the committee: Carol Farran, DNSc, FAAN, Louis Fogg, PhD (statistician), Arlene 
Miller, PhD, RN, Sarah Ailey, PhD, RN, and Olimpia Paun, PhD, PMHCNS-BC.
14
PUBLICATION OF RESEARCH FINDINGS
We will disseminate the findings from this study in scholarly oral presentations and 
written manuscripts and in the Long Term Care Facility community newsletters and oral 
presentations to family caregivers, administrators, and key stakeholders. If effective, this 
intervention will be translated into practice by training staff (i.e. social workers) to 
deliver the CGMI-V in their LTCF.
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Any presentation, abstract, or manuscript will be made available for review by the 
sponsor and the NIA prior to submission.
15
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SUPPLEMENTS/APPENDICES
APPENDIX A: INTERVENTION (CAREGIVER) MANUAL
APPENDIX B: INTERVENTIONIST MANUAL
APPENDIX C: RESEARCH ASSISTANT MANUAL
APPENDIX D: ICF
ORA: 18041811-IRB01   Date IRB Approved: 6/24/2019   Amendment Date: 5/4/2020