Caregiver Speaks: A Technologically Mediated Storytelling Intervention for Family Caregivers of Individuals With Alzheimer's Disease and Other Dementias
Phase: NA
Conditions: Alzheimer Disease
Sponsor: Washington University School of Medicine

Caregiver Speaks Protocol 
August 7, 2023 
NCT04103580 

Page 1 of 17 
SOCIAL/BEHAVIORAL/EDUCATIONAL RESEARCH PROTOCOL  
UNIVERSITY OF MISSOURI 
 
Project Title: Caregiver Speaks: A Technologically Mediated Storytelling Intervention for 
Family Caregivers of Individuals with Alzheimer’s Disease and Other Dementias 
IRB Number: 2016062 
Version Number:   11 
Version Date:   8.7.2023 
Principal Investigator: Abigail Rolbiecki, PhD, MPH, MSW & Debra Parker-Oliver, PhD, 
MSW 
Funding Source: National Institute on Aging (NIA) 
 
 
 
 
Over 15 million Americans living with Alzheimer’s disease and other dementias (AD/D) receive 
daily care from family caregivers (unpaid individuals, typically but not always related, who 
assume responsibility for daily care and decision-making).1 Caring for a person living with 
dementia (PLWD) greatly alters caregivers’ daily lives, often resulting in depression and anxiety 
as they labor throughout the illness trajectory.2-4 Caregiving challenges typically increase as the 
patient nears death.5-7 Family caregivers of PLWD often lack support during their most active 
caregiving and into bereavement. This situation intensifies both caregiving-related distress and 
caregivers’ grief.8 
 
Caregivers’ pre-bereavement experience is associated with how well they adapt to their post-loss 
lives.7,9 Caregivers who experience pre-bereavement depression, anxiety, and inadequate social 
support are likely to experience more intense grief and distress after their loved one dies.10,11 
Thus, interventions that reduce caregivers’ pre-bereavement depression and anxiety may 
improve the caregiving experience and bereavement journey.6 
 
Hospice is one of the few healthcare services that follow caregivers into bereavement. Although 
Medicare Conditions of Participation require hospice agencies to deliver bereavement services, 
no standards exist to prescribe how these services are delivered.12 Furthermore, many hospice 
agencies lack resources to provide comprehensive services to all bereaved caregivers.12 Current 
efforts for supporting hospice caregivers of PLWD show little efficacy at reducing pre- and post-
loss depression and anxiety during caregiving and into bereavement.7 We propose a randomized 
controlled trial (RCT) of a technologically-mediated, storytelling intervention, Caregiver Speaks. 
Caregiver Speaks empowers caregivers’ self-expression, moderated by increased social support, 
to make meaning of the caregiving and bereavement experiences, thus reducing depression and 
anxiety. 
 
Park and Folkman’s meaning-making coping model13 posits that an individual’s ability to make 
sense of, and find benefit in, an adverse life situation (e.g., caregiving and bereavement) will be 
enhanced by social support, resulting in reduced depression, anxiety, and grief intensity.13,14 
Caregiver Speaks will employ photo-elicitation – using photos to elicit caregivers’ thoughts and 
feelings about their experiences – and a private Facebook (FB) group to enable them to capture 
and share their stories with one another in a supportive online environment. The overarching 
goal of this application is to determine the efficacy of Caregiver Speaks in reducing depression 
I. 
Research Objectives/Background 

Page 2 of 17 
and anxiety among hospice family caregivers of people with end-stage AD/D. Our specific aims, 
qualitative research questions, and quantitative hypotheses are as follows: 
 
Specific Aim 1: Determine the efficacy of the Caregiver Speaks intervention in reducing 
depression and anxiety among hospice family caregivers of PLWD. 
Research Question (RQ) 1: What is the effect of the Caregiver Speaks intervention on 
caregivers’ depression, anxiety (outcomes of interest)? 
Hypothesis (H) 1a: Family caregivers receiving the intervention will report lower levels 
of depression and anxiety (outcomes of interest), which is facilitated by higher social 
support (mediating variable) than those in the control group during active caregiving.  
H1b: Family caregivers receiving the intervention will report lower levels of depression 
and anxiety (outcomes of interest), which is facilitated by higher social support 
(mediating variable) than those in the control group during bereavement. 
H1c: Among the intervention group, family caregivers with higher baseline depression 
scores will experience a larger reduction in depression compared to those with less 
depression at baseline. 
Specific Aim 2: Examine the effect of the Caregiver Speaks intervention on grief intensity 
among bereaved hospice family caregivers of PLWD. 
H2: Bereaved family caregivers receiving the intervention will report lower grief 
intensity (outcome of interest) than those in the control group. 
Specific Aim 3: Describe how caregivers make meaning of their caregiving and bereavement 
experiences. 
RQ 2: In what ways do active caregivers find meaning as reflected in their FB posts? 
RQ 3: In what ways do bereaved caregivers find meaning as reflected in their FB posts? 
RQ 4: In what ways does social validation in an online group facilitate meaning making? 
A two-arm multi-site RCT with a mixed-methods analysis will examine the efficacy of a 
photo-elicitation intervention to reduce caregiver anxiety and depression (Aim 1-2). 
Qualitative methods will provide insight into how the intervention works to enhance 
meaning-making and improve caregiver outcomes (Aim 3). 
 
Sub-Study: 
RQ: How are sibling relationships shaped by caring for a parent with dementia? 
RQ2: How are sibling relationships shaped by parental death and bereavement in the 
context of dementia? 
 
 
 
 
Participants will be hospice family caregivers of PLWD. In the U.S., hospice serves most 
individuals in their home, which may include nursing homes and other long term care 
environments, therefore our sample includes these locations. Moreover, we understand that other 
illnesses often exist alongside an AD/D diagnosis and will account for this in our analysis. 
 
The setting will consist of five hospice agencies in the U.S. These hospice agencies will serve a 
diverse population, including rural, urban and suburban areas.  
II. 
Recruitment Process 

Page 3 of 17 
 
We will randomly assign hospice family caregivers to either an intervention group (Caregiver 
Speaks plus usual care) or control group (usual care). The random assignment will last from 
active caregiving through bereavement. Upon enrollment in hospice, a hospice staff member will 
give eligible caregivers a brochure explaining the study. If family caregivers express interest, the 
staff member will request their verbal permission for a member of our research team to contact 
them via phone. We have successfully used this recruitment strategy in a prior study.15 
Prior to study onset, the central Data Manager (RK) will computer-generate a sequence of 
random group assignments (intervention, usual care) for each hospice site to ensure equal 
distribution of groups across study sites. Sequences will be generated in randomly chosen blocks 
of 6, 8, and 10 to prevent any study personnel from being able to forecast group assignment. The 
randomization schedule for each site will be uploaded into the REDCap database for the study. 
Upon consent, the next available randomization assignment for the site will be assigned to the 
patient; all caregivers for that patient will receive the same randomized group to avoid 
contamination between groups. 
 
During this orientation call, caregivers assigned to the Caregiver Speaks intervention will then 
receive assistance in setting up Facebook, information regarding privacy concerns for photo 
taking, and instruction regarding their participation in the intervention from the research staff. 
Caregivers in the usual care group will receive instruction on how to complete the measures in 
the REDCap survey. 
 
 
 
Hospice admission staff will screen eligible participants in compliance with privacy and 
confidentiality regulations, and briefly explain the study. If an eligible participant is interested 
and gives consent for a research staff person to contact them, an online orientation session will 
be scheduled (by the research staff) in order to go over the study in detail, and obtain verbal 
consent to participate in research activities, and will occur via zoom. During this meeting, an 
informed consent form will be read aloud to the participant, and they will be given contact 
numbers for additional information as well as contact information for the University of Missouri 
Institutional Review Board (IRB). The consent form emphasizes that caregivers can discontinue 
their participation at any time, and that refusal to participate will not affect their relationship to 
the hospice agency or the quality of care they receive. The consent form is attached to a follow-
up email with the link to complete the baseline measures via REDCap. The baseline survey will 
not open with the following statement: If you are randomized into the intervention group, 
participation will require ongoing Facebook use. By checking, ‘yes, I agree to participate’ below, 
you are acknowledging that Facebook use is part of the intervention activities. You will have 
many opportunities to ask questions about study involvement, and more specific instructions will 
be provided to you after you provide consent. If you check, ‘No, I do not want to participate’, the 
survey will end, and you will no longer be included as a consent in the Caregiver Speaks study.  
 
REDCap Referral and Consent Database Changes as of 9/7/2021:  
 
III. 
Consent Process 

Page 4 of 17 
• 
Indicator (yes/no) will be added to the consent form that denotes whether or not the 
intervention ‘teach back’ was included during the consent process.  
• 
Caregivers will be asked about other family members who might be interested in 
participating in the study, a notes field will be included so that this information can be 
added.  
• 
Indicator (yes/no) will be added to the referral form to indicate if the Medical Record 
(MRN) for the patient was thoroughly searched. A notes field will also be added so that 
additional MRN info can be noted.  
• 
Indicator (yes/no) added to account for caregivers who initially consent, but subsequently 
are removed as consents because they did not fill out the baseline and ignored staff 
contact or opted out of participating wen. If ‘yes’ is indicated, a notes field is triggered so 
that the reason for removal can be added as well.  
 
REDCap Referral and Consent Changes as of 6/16/2022:  
 
• 
When making the initial recruitment call, two questions will be added as a digital literacy 
screening. If the referral scores 6 or lower on either of the digital literacy screening 
questions, an alternate recruitment script will be utilized emphasizing the technological 
assistance the research team can provide to participants. 
• 
Digital literacy screening questions: 
• 
On a scale of 1-10 with 1 being poor and 10 being excellent, how do you rate your 
overall skills with technological devices such as cell phones, computers? 
• 
On a scale of 1-10 with 1 being poor and 10 being excellent, how do you rate your 
overall skills with social media applications such as Facebook? 
 
 
 
Participants must 1) be a designated family caregiver (i.e., a family member or friend providing 
unpaid care) of a PLWD who is enrolled in hospice care, 2) be at least 18 years old, 3) be 
involved in decisions related to their loved one’s hospice care, 4) have access to a digital camera 
or other photo-taking device such as a cell phone, 5) be willing to photograph images they feel 
capture their caregiving and bereavement experiences, 6) be willing to set up a Facebook account 
and join the private Facebook group, and 7) have access to e-mail for REDCap survey data 
collection. Family caregivers without an internet-enabled device will be given a smart phone and 
data plan restricted to Facebook use for the duration of their participation in the study. 
 
 
1. The anticipated enrollment number is 468 subjects (or 234 for intervention group and 234 
for control).  
2. The PHQ-9 is widely used, has good internal consistency, is well validated, and is 
commonly used to inquire about the degree to which an individual has experienced 
depressed mood over the past two weeks.16 Our power calculations based on our 
preliminary work hold the following assumptions: 1) attrition rate of 30% 2) 80% power 
IV. 
Inclusion/Exclusion Criteria 
V. 
Number of Subjects 

Page 5 of 17 
3) a two-sided alternative for group differences at the 0.05 level of significance for a 
change in PHQ-9 scores (average of 4 points, variance of 5.5). 
 
 
 
Group 1: Usual care. Participants in this group will receive standard hospice care and 
bereavement support according to the policy of each hospice agency. We considered using an 
attention match control but chose “usual care” instead, as prior research demonstrated that using 
attention match control in a behavioral randomized trial is problematic,17 especially for outcomes 
such as depression (our primary outcome of interest) and anxiety. This literature advocates that 
controlling for attention is not necessary and counterproductive in some behavioral intervention 
trials.17 Once assigned to an arm, the participant remains in that arm for the entire study, from 
active caregiving through bereavement. We will not randomize a second time at bereavement. 
Control group participants will complete study measures electronically through the REDCap 
system at the same intervals as the intervention group. 
 
Group 2: Caregiver Speaks intervention group. Participants in this group will receive usual 
care plus the Caregiver Speaks intervention. They will participate in a Facebook group to share 
their photos and personal stories. During the initial zoom meeting, a research staff person will 1) 
train caregivers how to set-up and use Facebook, if needed, 2) discuss elements of their story and 
identify artifacts they may wish to feature in their photo-elicitation process, and 3) enroll them in 
the pre-bereavement caregiver private Facebook group. Caregivers will participate in this group 
until the PLWD dies, at which time they will transition (one month) into a bereavement focused 
group. The bereavement group will include the same components, but the focus of the photos 
and conversation will be on bereavement. Table 1 provides a summary of the study and 
intervention participation, as well as the data collection schedule. We will provide caregivers a 
printed reference guide for using Facebook, including group rules and common Facebook terms, 
based on materials we have used extensively in our preliminary work.18 
 
In an effort to increase retention of participants, the interventionist will now add a follow-
up/technical assistance phone call with each NEW intervention participant after they have 
completed one full week of the intervention to assess the following: 
a. whether or not there are barriers to accessing/using Facebook.  
b. whether or not caregivers are able to share photos. 
c. whether or not they know how to set up their notifications to alert them of new posts in the 
group.  
d. whether or not they understand what to share in the group. 
Table 1 Summary of Study/Intervention Participation for Caregiver Speaks  
Time 
Study/Intervention Procedures 
Recruitment and 
Randomization 
Flyer given to interested participants by hospice admissions staff, 
consent given for research staff to contact participant. In addition 
to that we will send recruitment information packets to some 
referrals by mail. We will send declines as referrals to another 
study. Encode (1R01AG069936). Initially consented participants 
will be given a brief explanation of study-by-study staff and asked 
VI. 
Study Procedures/Study Design 

Page 6 of 17 
 
The Facebook group will possess the highest privacy level Facebook offers (secret group). Only 
consented users can search for secret groups; internet searches cannot find them. Membership in 
a secret Facebook group requires an invitation by a group administrator. Hospice family 
caregiver participants will be encouraged to log in at least once a week to read content, post 
photos, and share their stories with other caregivers. 
 
PI Rolbiecki (expert in storytelling and photo-elicitation) and Co-I Teti (photo-elicitation expert) 
will train and supervise a research team member to serve as the primary Facebook moderator. 
The moderator will monitor the interactions and discussions among participants daily. Drs. 
Rolbiecki and Teti and two additional staff will support the facilitation when needed. Based on 
our pilot work and effectiveness trial (R24HS022140) of photo-elicitation storytelling and 
Facebook groups, one full-time facilitator will be responsible for up to 100 group members at a 
time. 
 
Our preliminary work demonstrated that Facebook group members participated more when the 
moderator asked them to post pictures that captured their experiences, asked questions about the 
photos, and engaged other members in discussion about the photos. Therefore, the moderator 
will ask active caregivers to post photos representing their caregiving experiences, their 
caregiving process, and their meaning structures (e.g., this is what my family dynamic looks like 
now, while actively caring for my ill family member; this is how my life changed when I 
assumed the caregiving role; these are the types of things we do as a family now that I am 
actively caregiving) as related to the month’s theme. The moderator will encourage active 
discussion and posting, weekly (related to the theme). In the bereavement group, the same 
moderator will ask members to share photos capturing their experiences with death and loss and 
their post-loss meaning structures (e.g., this is how my family dynamic has changed since the 
loss; I am now able to do these things again post-loss; this is how my life changed post-loss). 
The photo-elicitation process is described below.  
for verbal consent to participate. Randomization occurs. Zoom 
meeting (orientation) scheduled. 
Zoom (orientation) meeting  Instructions given to intervention group for Facebook and photo-
elicitation procedures 
Monthly (pre-bereaved 
caregiver Facebook group) 
Research staff will provide ongoing facilitation and encourage 
discussion of photos and caregiver experiences based on monthly 
themes. Research staff will encourage participants to post weekly. 
1-month bereavement 
transition 
Once bereaved, caregivers will have one month to transition into 
the bereavement group. Research staff will 1) walk them through 
the steps of joining the bereavement group, 2) give instructions, 
and 3) conduct a brief, semi-structured, qualitative interview. 
Monthly (bereaved 
caregiver Facebook group) 
Research staff will facilitate discussion of photos based on 
monthly themes. This will continue up to ~180 days (6 months) 
after the death of their loved one. Research staff will encourage 
participants to post weekly. 
Study exit 
Termination and follow-up: participants will terminate from the 
group, and will complete 180-day survey and follow-up interview. 

Page 7 of 17 
 
Caregivers who express a need for additional psychological support will be referred to a hospice 
social worker (before their family member dies) or hospice bereavement counselor (during 
bereavement). Although we have found Facebook to be an effective platform where members 
deliver stories and engage with others with similar experiences, important ethical issues are 
inherent with this approach. This group is designed for research purposes only. Any caregivers 
who demonstrate crisis or express intent to harm themselves or others will be dealt with 
respectfully by the qualified research staff person monitoring the group. Supportive materials 
(e.g., suicide crisis hotline phone numbers, national information regarding dementia caregiver 
support) will be made available to any caregiver who expresses interest or demonstrates a need. 
 
Photos are the primary medium through which participants will engage with other group 
members, responding to the prompts described by the facilitator. Before their loved one dies, 
caregivers will be asked to take photographs that they feel best capture their daily caregiving and 
share them with other caregivers in the pre-bereavement Facebook group. The primary group 
moderator will ask caregivers to focus their photo-taking and discussion on their pre-loss 
meaning structures (including their pre-caregiving lives) and how this has changed over the 
course of the illness. For example, caregivers may capture their daily activities caring for their 
family member, their perceptions of themselves and their interpersonal relationships (including 
how these changed when they assumed the caregiver role), and how caregiving affects their 
views of the future and their world. Caregivers who enter the bereavement phase of the study 
will be asked to take photographs capturing their post-loss meaning structures (e.g., how their 
sense of self has changed in bereavement, re-examined priorities for life, relationships with the 
living and continued bonds with the dead, and how their views of the world and future have 
changed). Members will be asked to discuss these things with others in the bereavement group. 
 
See Table 2 (below) for data collection timing, measures (including psychometric properties), 
and our specific aims, which focus on key aspects of our conceptual model. Our planned data 
collection frequency mirrors procedures in our other clinical trials in hospice, allowing us to get 
measures closest to the patient’s death and also through a significant amount of time in 
bereavement. 
Table 2: Aims, Hypotheses, and Associated Measures 
Pre-bereavement measures collected at baseline, 14, 30, 90, and 150 days (follow-up data collection post 150 
days will occur every 6 weeks until participant transitions to bereavement). Post-death measures collected at 
transition, 14, 30, 90, 150 and 180 days. During study wind down, participants will complete their final data 
collection measure based on where they are at in the intervention (e.g., if a participant is on day 90 of 150, 
they will complete day 90 survey as their final measure). 
Specific Aim 
Hypotheses (H) and 
Research Questions (RQ) 
Instruments and 
Variables 
Description 
Aim 1: Determine the efficacy 
of the Caregiver Speaks 
intervention in reducing 
depression and anxiety among 
hospice family caregivers of 
PLWD. 
RQ1: What is the effect of the 
Caregiver Speaks intervention on 
caregivers’ depression, anxiety 
(outcomes of interest)? 
H1a: Family caregivers 
receiving the intervention will 
Primary Outcome: 
Depression Patient 
Health Questionnaire 
(PHQ-9) 
Secondary Outcome: 
Anxiety Generalized 
PHQ-9: a 9-item 
screening tool and 
severity measure 
for depressive 
mood.19 Internal 
Consistency: .8720 

Page 8 of 17 
report lower depression and 
anxiety (outcomes of interest), 
which is facilitated by higher 
social support (mediating 
variable) than those in the control 
group during active caregiving. 
H1b:  Family caregivers 
receiving the intervention will 
report lower depression and 
anxiety (outcomes of interest), 
which is facilitated by higher 
social support (mediating 
variable) than those in the control 
group during bereavement. 
H1c: the intervention group, 
family caregivers with higher 
baseline depression scores will 
experience a larger reduction in 
depression compared to those 
with less depression at baseline. 
Anxiety Disorder 
(GAD-7) 
 
Mediating 
Variables: Social 
Validation & 
Growth: Social 
Meaning in Life 
Events Scale –Social 
Validation SMILES-
SV  
 
 
Integration of 
Stressful Life 
Experiences Scale  
Short Form (ISLES-
SF) 
Caregiver Quality of 
Life Index (CQLI-R) 
 
GAD-7: a 7-item 
screening tool and 
severity measure 
for generalized 
anxiety. Internal 
Consistency: .8921 
 
SMILES-SV: a 9-
item tool for 
measuring social 
validation and 
meaning-making 
during stressful 
life events. 
Internal 
Reliability: .8422 
 
ISLES-SF: a 6-
item measure that 
assess meanings 
made of stress 
during 
bereavement.23 
 
CQLI-R: a 4-item 
scale that 
measures 
physical, social, 
emotional, and 
financial quality 
of life among 
active caregivers.  
Aim 2: Examine the effect of 
the Caregiver Speaks 
intervention on grief intensity 
among bereaved hospice family 
caregivers of PLWD 
H2: Bereaved family caregivers 
receiving the intervention will 
report lower grief intensity 
(outcome of interest) than those 
in the control group. 
Secondary Outcome: 
Grief Intensity Texas 
Revised Inventory of 
Grief (TRIG)-Present 
Scale 
TRIG-Present: a 
13-item scale 
measuring present 
grief among 
bereaved 
individuals. 
Internal 
Consistency: 
.8624,25 
Aim 3: Describe how caregivers 
make meaning of their 
caregiving and bereavement 
experiences  
RQ2: In what ways do active 
caregivers find meaning as 
reflected in their FB posts? 
Caregiver Photos, 
Discussion of Photos 
via Facebook Group, 
Post-intervention 
Qualitative data 
triangulation and 
mixed methods 
analysis. 

Page 9 of 17 
 
Data Analysis Plan:  
Statistical Assumptions. We will examine linearity and homoskedasticity by calculating and 
plotting residuals and Cook's distance for all models. Where data are missing, we will use the 
Last Observation Carried Forward (LOCF) missing data imputation technique, given that < 30% 
of data were missing for any particular subject in our prior work. If the proportion of missing 
data is higher, we will use regression based multiple imputation. Little’s MCAR test (missing 
completely at random) will be used to test that missingness is in no way related to the 
intervention. Because the sample size is relatively large, we expect that known and unknown 
confounders will be distributed evenly among the two randomized groups. Additional 
confounders will only be introduced as covariates if we find evidence of imbalance between 
groups at baseline. We acknowledge that this study is not powered to detect small interaction 
effects. 
 
We will test whether randomization created balanced groups by comparing baseline measures 
and demographic characteristics, using chi-square or t-test analysis for categorical or continuous 
variables, respectively. Variables that differ significantly between groups will be included in 
regression models as potential confounders. We will include time from study enrollment to the 
last observation as a covariate, as well as hospice agency. We will report estimates with 95% 
confidence intervals. To draw inferences from our study for the likely benefit to an equivalent 
population, where the intervention under trial is a model of service delivery, all analyses of 
outcomes will be by intention-to-treat. The intention-to-treat analysis, consistent with the 
objectives of a pragmatic trial, will minimize the influence of “informative missingness” of the 
data and preserve groups’ comparability. 
 
Statistical Analysis. H1a: Family caregivers receiving the intervention will report lower levels 
of depression and anxiety (outcomes of interest), which is facilitated by higher social support 
(mediating variable) than those in the control group during active caregiving. 
H1b: Family caregivers receiving the intervention will report lower levels of depression and 
anxiety (outcomes of interest), which is facilitated by higher social support (mediating variable) 
than those in the control group during bereavement. 
 
We will examine differences between longitudinal profiles of the two study groups for each of 
the outcomes (PHQ-9, GAD-7, and grief intensity). We will use linear mixed effect repeated 
measurement (MMRM) (see model below). This will allow us to draw inferences about how our 
outcome measures (PHQ-9, GAD-7 and grief intensity) change over time (slope =β_(1,T) and 
β_(1,C) ) between the two study groups. Mixed models are able to accommodate differing 
numbers of measurements at varying time intervals for participants. Additionally, we will 
examine how social support mediates our outcomes of interest (depression, anxiety, and grief 
intensity). As described above, we will also include covariates where indicated. 
RQ3: In what ways do bereaved 
caregivers find meaning as 
reflected in their FB posts? 
RQ4: In what ways does the 
social support in an online group 
facilitate meaning making? 
Interviews,  
SMILES-SV, ISLES-
SF, and Grief 
intensity scale 

Page 10 of 17 
 
Y_ij= β_(0,T)  + β_(1,T) t_ij+ b_oi+ e_ij      for Treatment group 
= β_(0,C)  + β_(1,C) t_ij+ b_oi+ e_ij      for Control group 
 
Where Y_ij represent the depression/anxiety score of the i^th subject at the j^th time, β_(1,T) 
and β_(1,C) represent the slopes for the treatment and control group respectively with intercepts 
that vary about the respective mean intercepts β_(0,T) and β_(0,C). 
 
H1c: Among the intervention group, family caregivers with higher baseline depression scores 
will experience a larger reduction in depression compared to those with less depression at 
baseline. 
 
A multiple linear regression model will be used as for H1a above to examine the modifying 
effect of baseline PWBS score. If the β_2 coefficient is negative and statistically significant, we 
will conclude that the effects of the Caregiver Speaks intervention are conditional on baseline 
perceptions after adjusting for duration of caregiving (time). 
Last post-baseline Anxiety/depression = β0 + β2 * [baseline anxiety/depression] + β3 * [time] 
 
H2: Bereaved family caregivers receiving the intervention will report lower grief intensity 
(outcome of interest) than those in the control group. 
A linear mixed effect model similar to those used for H1a and H1b will be used to examine H2, 
where the Y_ij will represent the grief intensity score for a subject of the i^th subject at the j^th 
time. 
 
Subgroup Analysis. We will analyze several subgroups to identify unique attributes that might 
influence outcomes. Our subgroups are 1) hospice agency, to reflect different organizational 
structures, 2) older age, gender, race & ethnicity, which might influence use or understanding of 
Facebook, 3) Caregiver relationship to and residence with the patient, which could affect the 
meaning and amount of burden and 4) Time from enrollment to last observation, which reflects 
intervention dose, and 5), co-morbidities in patients, which may impact caregiving outcomes. 
 
Qualitative Analysis. See Table 3 (below) for a detailed qualitative analysis plan. We will enter 
all photos, qualitative Facebook data, and transcribed interviews into qualitative coding software 
(Dedoose) for triangulation (use of multiple data sources to ensure a rich and robust dataset)26,27 
and thematic analysis.28 
 
 
Table 3 Qualitative Data Analysis Protocol 
Phase 1: Coding – We will rely on our preliminary work to inform data coding and categorization. We 
will begin with a coding frame based on prior research and the theoretical framework.29 Drs. Rolbiecki, 
Teti, and Washington will take part in analyzing the triangulated data (i.e., the Facebook discussions, 
photos, and interviews), including discussing and agreeing on the utterance meanings of each code. Once 
the final list of codes is complete and agreement on codes is met, each qualitative committee member will 
code separately and meet to discuss interpretations. The coding frame will be modified throughout 

Page 11 of 17 
analysis, and the committee will review data as they become available. As a way to guide the thematic 
analysis process, codes emerging from the data will be labeled by at least two members of this committee 
and discussed at weekly team meetings. Inter-relator reliability (i.e., a Kappa statistic) will be computed 
via the Dedoose qualitative coding software. When Kappa is .80, we will divide the data and code 
individually. 
Phase 2: Pattern Identification and Thematic Analysis – We will build on Phase 1 by reducing the 
codes until we can make meaning of the data and identify patterns. This reduction process will consist of 
grouping the codes into smaller themes, or constructs. We will create a cognitive map of the schema for 
each dataset (control and intervention). All codes will be further reduced and condensed until we reach a 
consensus on overarching themes that we feel tell the best story of the data and relate to our research 
questions. 
Phase 3: Trustworthiness – Along with data triangulation (which is also used to increase trustworthiness 
of qualitative data analysis)30, the qualitative data analysis committee will utilize 1) co-coding, 2) peer 
debriefing with weekly research team meetings, and 3) a strong audit trail linked in a database. 
 
 
1.  
 
Potential Risks: Hospice family caregivers will incur minimal risk by participating in the study. 
Potential risks could include frustration or anxiety with malfunctioning or technically deficient 
equipment. Some individuals entering the study might not know how to use Facebook, which 
may cause some anxiety or frustration. Participants may feel nervous about sharing photos on 
Facebook and engaging with other hospice family caregivers via the private group. They may 
also feel uncomfortable discussing their caregiving experiences, as well as their bereavement 
experiences on this platform. As in most studies, despite efforts to protect confidentiality, 
potential exists for a privacy breach that could cause distress or embarrassment. All paper forms 
and computerized data will be stored in secure environments to minimize this possibility. 
Finally, the potential for frustration exists in that study personnel will have an initial phone 
meeting (orientation) at the beginning of the study as well as communicate with them by phone 
at the point they become bereaved. We will continue to minimize these risks by being 
considerate as we contact family by phone. We also assure participants, both verbally and in 
writing that they may withdraw from the study at any time. Finally, hospice staff will not release 
names of any potential participants to the research team without first obtaining consent that the 
research staff can contact them.  
The Facebook platform presents special considerations of risk and privacy. The consent form 
will make these issues known, and the protocol will require research staff to review participants’ 
privacy settings. We recommend the strictest settings. We will tell potential participants that, if 
they join the study, their name will be added to a “closed secret” Facebook page, giving them 
access to other hospice family caregivers of persons living with dementia (PLWD) enrolled in 
the study. Although the research team controls membership in this group, which is not available 
VII. 
Potential Risks 

Page 12 of 17 
to the general public, participants will be advised to protect their personal information and 
privacy with their individual privacy settings. Members of the Facebook group may contact one 
another through the Facebook website. However, the research team will not share participants’ 
personal contact information. To participate in the study, participants must join Facebook and 
have an account. They will be advised to read the Facebook privacy policy and set their 
Facebook privacy settings with the tightest controls. Our research staff will walk participants 
through the privacy settings to assist in understanding their meaning. However, participants will 
decide on their Facebook privacy settings. They will be told that the settings of other group 
members might affect the privacy of what they share. We also will inform participants of 
Facebook’s policy that it owns all materials placed on the Facebook website, and will advise 
them to read the policy when posting photos. Should participants feature non-consented 
individuals in their photos, they will be asked to obtain verbal consent from these individuals 
before posting the photo in the group. All photos of non-consented individuals will be blurred 
and de-identified. We will inform participants that, as members of the secret Facebook group, we 
will encourage them to discuss experiences, share caregiving advice, and access questions and 
concerns regarding similar issues with others enrolled in the study. Each week, the research staff 
will provide a new information posting and discussion prompt. We will tell participants that 
nothing is required of them and that they may log onto the site and read and respond (or not 
respond) to the discussion as they choose. Our research team will supply discussion information 
and review all comments and responses to determine members’ needs and the helpfulness of the 
Facebook page. Participants will be given a Rules of Conduct document outlining the ethical 
conduct expected of the Facebook participants. These rules proscribe giving medical advice to 
other caregivers or being critical of them. If a participant breaks the rules, the research staff can 
speak privately with them and, if necessary, after consultation with the Principal Investigators 
(Drs. Parker-Oliver and Rolbiecki) and research team, revoke their access to the page. The need 
for this never occurred in our pilot studies. While the Facebook group will not be physically 
monitored 24/7, all study staff will receive alerts (via Facebook) indicating when and what 
participant’s post. A designated monitoring schedule will be set-up and the Facebook group (and 
alerts) will be monitored by an actual research staff person between the hours of 7amCST and 
10pmCST. Any potential breaches of this code of conduct will be addressed, immediately, the 
following day. This protocol will be communicated to all participants. This Facebook group does 
not replace hospice services. Neither the research staff nor any member of the Facebook group 
will provide mental health services such as counseling. If the research staff becomes concerned 
about a caregiver’s mental well-being, they will contact the hospice social worker to assure the 
safety of the caregiver and others. 
 
Protection against Risk: Caregiver confidentiality and comfort with the technology are 
protected, for caregivers must agree to participate in the study’s Facebook page on their own 
account. Training staff to understand their role in recruiting participants, as well as preventing a 
breach of their confidentiality will address this concern. All paper forms and recordings will be 
kept in locked cabinets in locked offices within a locked suite. All computerized data will be 
stored on password-protected and encrypted computers and networks. Only study personnel with 
a specific need to use data will be granted permission to access it. Finally, all patient/family 
information taken from the home or hospice office will be identified not with names but with an 
arbitrary identification code. Hospice family caregivers will participate in recorded interviews, 

Page 13 of 17 
and all recordings will be transcribed and stripped of identifying information. All research data 
that leave the hospice office will be maintained in a locked file cabinet and secure computer in 
the PI’s office. If written consent is required, the research staff will collect all hard copies of 
consent forms and hand deliver them to the PI during supervision visits. 
 
 
 
The proposed project has the potential to improve hospice services by improving hospice support 
of caregivers from active caregiving and into bereavement. This project’s social media platform 
(Facebook) connects caregivers with other caregivers in a privately moderated group, fostering 
an environment in which they can obtain additional information and social support that improves 
both active caregiving and bereavement experiences.  
 
 
 
Subjects will be compensated $100 total. One payment of $50 will be made via a check at the 
transition period, and the second $50 payment after completion of their exit interview. During 
study wind down, all participants will receive their final payment on or around the time of their 
final survey. Meaning, if participants are on day 90 of 150 and they complete day 90 as their 
final survey, investigators will initiate final payment. All participants will receive the total 
amount of their compensation ($100) at the completion of their final survey, regardless of 
whether they have entered the bereavement phase. 
 
 
 
This project seeks to test the efficacy of the Caregiver Speaks intervention and explore how 
caregivers’ making meaning of their caregiving and bereavement experiences affects their grief 
intensity. To our knowledge, this is the first hospice intervention offered during active 
caregiving, following caregivers into bereavement that utilizes the innovative storytelling 
technique of photo-elicitation. The study will occur in geographically separate hospice programs 
across the Missouri and in Pennsylvania. The study will use block randomization, with block 
sizes randomly varying between 6 and 10 to randomize participants into control and Intervention 
groups, making group allocation difficult to discern. The Data Manager will prepare sequentially 
numbered, opaque envelopes using a computer to generate random numbers.  The total sample 
will be 468 hospice family caregivers of PLWD in Missouri and Pennsylvania. Participants will 
be at least 18 years of age, meet the study’s inclusion criteria and provide consent to participate. 
The sample will be referred by hospice admissions staff following a consent-to-contact 
discussion with the caregiver. Participants in the usual care group will receive traditional hospice 
care and will be asked questions from the instruments upon enrollment, and every 30 days up to 
180 days bereaved. We will conduct a follow-up transition interview with the family caregivers 
in for the intervention group only at 14-21 days following death of their loved one, then again at 
~100-110 days bereaved (for intervention group only). Participants in the Caregiver Speaks 
intervention group will receive the same measures in addition to the following: participation in a 
secret Facebook group and facilitated photo-elicitation storytelling intervention. As part of 
VIII. Anticipated Benefits 
IX. 
Compensation 
X. 
Data Safety Monitoring Plan 

Page 14 of 17 
overseeing the Facebook group’s psychosocial concerns, Co-investigator Dr. Washington will 
contact any participant reporting thoughts or actions of harming themselves or others via the 
Facebook discussion and initiate the participant safety plan.  
 
The Co-Principal Investigators (Drs. Parker-Oliver and Rolbiecki) and Data Manager (Dr. 
Kruse) will be responsible for monitoring the safety and efficacy of this trial, executing the Data 
and Safety Monitoring plan, and complying with the reporting requirements. The PIs will 
provide a summary of the report to the National Institute on Aging (NIA) annually as part of the 
progress report. The Data and Safety Monitoring report will include participants’ socio-
demographic characteristics, expected-versus-actual recruitment rates, retention rates, any 
quality assurance or regulatory issues that occurred during the past year, summary of Adverse 
Events and Serious Adverse Events, and any actions or changes regarding the protocol.  
 
We will use the Research Electronic Data Capture (REDCap) online database management 
system that the University of Missouri provides. In this secure network, we will store all study 
data, data collection instruments, schedule follow-up assessments, monitor enrollment, and 
manage secure storage. The University of Missouri School of Medicine Bioinformatics 
Department will provide database management technical support for the data-capture system. 
Data will be collected via an e-mailed link to all participants with instructions for them to 
complete the surveys. Based on entered data, the Data Manager will produce reports of apparent 
data discrepancies and missing data. Data concerns will be addressed through the Data/statistical 
team and reported to the Steering Committee. Larger concerns with the protocols may be 
forwarded to the full team or institutional committees depending on their severity. Intervention 
fidelity will be monitored monthly by Drs. Rolbiecki and Teti. Data quality will be monitored by 
random inspection of the completed forms by the Data Manager, and any problems detected will 
be discussed with the Steering Committee. 
 
During screening, study applicants will be assessed to determine their eligibility and safety of 
their participation in this study. We will use the University of Missouri Institutional Review 
Board (IRB) definition of serious adverse events. The IRB understands that this definition is 
unusual in hospice, where deaths are not considered an adverse event because all hospice 
patients are expected to die. Any adverse event, whether or not related to the study intervention, 
will be reported to the IRB  
 
All personnel involved with this study will receive appropriate IRB training, including for human 
subjects training and HIPAA. The PIs will maintain certification of this training.  
 
Responsibilities for data monitoring and safety are outlined below: 
 
• Co- Principal Investigators: The Co- PIs will supervise the study personnel. They 
will monitor the day-to-day implementation of the intervention and all data 
collection. They will be in regular contact with each hospice and readily available 
to identify safety concerns and solve problems. Adverse events that are reported 
to or observed by the Co-PIs will be reported to the Total Research Team, 
University of Missouri IRB, and Health Sciences Data Monitoring Safety Board 
as requested. 

Page 15 of 17 
• Steering Committee: The research team includes all faculty Co-Is and research 
staff. Research staff will report all observations, concerns or issues related to the 
safety of participants or the collection of data. The Co-PIs and Research 
Specialists will meet weekly to review the status of the intervention, identify 
problems in the study.  
• Each committee meets regularly and reports to the Steering committee any data or 
safety concerns. All members of the research team are responsible for assuring 
that any adverse events are reported to the University of Missouri IRB. 
 
 
 
As we have done in our past clinical trials, all IRB approvals are handled through one 
institutional IRB. This success has been contingent upon appropriate IRB training by all Co-Is 
and research staff credentialed through CITI IRB training with customized institutional modules. 
The IRB application will be submitted to the University of Missouri Institutional Review Board 
(MU IRB), which will serve as the single IRB with oversight of the study. Drs. Rolbiecki and 
Parker Oliver, Co- Principal Investigators, will be responsible for all communication between 
sites and will ensure appropriate IRB approvals are in place prior to the initiation of research 
activities. MU IRB will maintain records of authorization and of all pertinent communication. 
 
 
 
 
 
1. 
Alzheimer’s A. 2015 Alzheimer's disease facts and figures. Alzheimer's & dementia: the 
journal of the Alzheimer's Association. 2015;11(3):332. 
2. 
Pinquart M, Sörensen S. Differences between caregivers and noncaregivers in 
psychological health and physical health: a meta-analysis. Psychology and aging. 
2003;18(2):250. 
3. 
Pinquart M, Sörensen S. Associations of caregiver stressors and uplifts with subjective 
well-being and depressive mood: a meta-analytic comparison. Aging & mental health. 
2004;8(5):438-449. 
4. 
Sörensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? 
An updated meta-analysis. The gerontologist. 2002;42(3):356-372. 
5. 
Haley WE, Bergman EJ, Roth DL, McVie T, Gaugler JE, Mittelman MS. Long-term 
effects of bereavement and caregiver intervention on dementia caregiver depressive 
symptoms. Gerontologist. 2008;48(6):732-740. 
6. 
Schulz R, Boerner K, Shear K, Zhang S, Gitlin LN. Predictors of complicated grief 
among dementia caregivers: a prospective study of bereavement. Am J Geriatr 
Psychiatry. 2006;14(8):650-658. 
7. 
Schulz R, Hebert R, Boerner K. Bereavement after caregiving. Geriatrics. 2008;63(1):20. 
8. 
Godwin B, Waters H. ‘In solitary confinement’: Planning end-of-life well-being with 
people with advanced dementia, their family and professional carers. Mortality. 
2009;14(3):265-285. 
9. 
Stroebe M, Schut H, Stroebe W. Attachment in coping with bereavement: A theoretical 
integration. Review of General Psychology. 2005;9(1):48-66. 
XII. 
References 
XI. 
Multiple Sites 

Page 16 of 17 
10. 
Sanders S, Ott CH, Kelber ST, Noonan P. The experience of high levels of grief in 
caregivers of persons with Alzheimer's disease and related dementia. Death Stud. 
2008;32(6):495-523. 
11. 
Stroebe M, Schut H, Stroebe W. Attachment in Coping With Bereavement: A Theoretical 
Integration. Review of general psychology. 2005;9(1):48. 
12. 
Demmer C. A national survey of hospice bereavement services. OMEGA-Journal of 
Death and Dying. 2003;47(4):327-341. 
13. 
Park CL, Folkman S. Meaning in the context of stress and coping. Review of general 
psychology. 1997;1(2):115. 
14. 
Gillies J, Neimeyer RA. Loss, grief, and the search for significance: Toward a model of 
meaning reconstruction in bereavement. Journal of Constructivist Psychology. 
2006;19(1):31-65. 
15. 
Kruse RL, Parker Oliver D, Wittenberg-Lyles E, Demiris G. Conducting the ACTIVE 
randomized trial in hospice care: keys to success. Clinical Trials. 2013;10(1):160-169. 
16. 
Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. 
Psychiatr Ann. 2002;32(9):509-515. 
17. 
Freedland KE. Demanding attention: reconsidering the role of attention control groups in 
behavioral intervention research. Psychosom Med. 2013;75(2):100-102. 
18. 
Parker Oliver D, Washington K, Gage LA, Demiris G. The promise of secret Facebook 
groups for active family caregivers of hospice patients. Journal of palliative medicine. 
2014;17(11):1199-1200. 
19. 
Kroencke K, Spitzer R, Williams J. The PHQ-9: validity of a brief depression severity 
measure [Electronic version]. Journal of General Internal Medicine. 2001;16(9):606-613. 
20. 
Kocalevent R-D, Hinz A, Brähler E. Standardization of the depression screener patient 
health questionnaire (PHQ-9) in the general population. General hospital psychiatry. 
2013;35(5):551-555. 
21. 
Löwe B, Decker O, Müller S, et al. Validation and standardization of the Generalized 
Anxiety Disorder Screener (GAD-7) in the general population. Medical care. 
2008;46(3):266-274. 
22. 
Bellet BW, Holland JM, Neimeyer RA. The Social Meaning in Life Events Scale 
(SMILES): A preliminary psychometric evaluation in a bereaved sample. Death studies. 
2019;43(2):103-112. 
23. 
Holland JM, Currier JM, Neimeyer RA. Validation of the integration of stressful life 
experiences scale–short form in a bereaved sample. Death Studies. 2014;38(4):234-238. 
24. 
Crespo M, Piccini AT, Bernaldo-de-Quiros M. When the Care Ends: Emotional State of 
Spanish Bereaved Caregivers of Persons with Dementia. Span J Psychol. 2013;16. 
25. 
Faschingbauer TR, Devaul RA, Zisook S. Development of the Texas Inventory of Grief. 
The American journal of psychiatry. 1977. 
26. 
Carter N, Bryant-Lukosius D, DiCenso A, Blythe J, Neville AJ. The use of triangulation 
in qualitative research. Paper presented at: Oncology nursing forum2014. 
27. 
Patton MQ. Enhancing the quality and credibility of qualitative analysis. Health services 
research. 1999;34(5 Pt 2):1189. 
28. 
Braun V, Clarke V, Terry G. Thematic analysis. Qual Res Clin Health Psychol. 
2014;24:95-114. 
29. 
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative research in 
psychology. 2006;3(2):77-101. 

Page 17 of 17 
30. 
Korstjens I, Moser A. Series: Practical guidance to qualitative research. Part 4: 
Trustworthiness and publishing. European Journal of General Practice. 2018;24(1):120-
124.