Pilot Study of Depression and Pain Perseverance Through Empowered Recovery (DAPPER) Intervention
Phase: NA
Conditions: Pain, Depressive Symptoms, Frailty, Aging
Sponsor: Johns Hopkins University

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
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 Depression and Pain Perseverance Through Empowered Recovery Intervention NCT04091347 
 
 
IRB Protocol  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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JHM IRB - eForm A – Protocol 
 
 
 
• Use the section headings to write the JHM IRB eForm A, inserting the appropriate material 
in each. If a section is not applicable, leave heading in and insert N/A. 
• When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at 
the top of JHM IRB eForm A. 
 
**************************************************************************************
************* 
 
1. 
Abstract 
Older African American women experience disproportionate rates of chronic conditions in comparison to 
other groups. Pain, depressive symptoms, and frailty often co-occur in African American women aging 
with chronic conditions and this combination can lead to disability and poor quality of life. Addressing pain 
and depressive symptoms may improve or delay the progression to frailty. To our knowledge there is little 
work being done in this population to address both pain and depression. The Depression and Pain 
Perseverance through Empowered Recovery (DAPPER) program is person directed and will consist of 8 
nurse visits during which the nurse assesses each participant for pain, depression, and frailty, then 
implements a manualized individually tailored intervention.  The data collection visits, and nurse visits will 
take virtually.  We propose a pilot trial that is a wait list randomized control pilot to test the acceptability 
and obtain a preliminary effect size for the intervention. We will recruit 64  (>age 50) African American 
women who report pain intensity of 3 or higher that interferes with their activities, depressive symptoms 
lasting more than two weeks, are pre frail or frail, and live in the community/are not institutionalized. The 
sample will be recruited through the PI’s previous study, community recruitment flyers distributed 
virtually, and word of mouth campaigns. Participants will be randomized into either the intervention or the 
wait list control group. Once the intervention group has completed their visits, the wait list control group 
will begin their visits.  All participants will be offered the same information and format of nurse visits. The 
nurses will systematically tailor the content of the visits to the participants’ risk profile and goals based on 
protocols. All participants will be assessed at the start of the study, at 12 weeks, and 24 weeks. The primary 
outcomes will be pain, depressive symptoms, and frailty status.  Other endpoints include goal attainment, 
stress (cytokines), self-report, self-efficacy, and communication with health care providers. We will also 
examine the acceptability of the intervention using intervention compliance and one-on-one qualitative 
interviews. This study will offer either virtual or in person visits based on the preference of the participants.  
  
 
2. 
Objectives  
 
The aims of this pilot project are to 1) test the Depression and Pain Perseverance through Empowered 
Recovery (DAPPER) program for feasibility and acceptability.  Specifically, we will 1) test the effect size 
of DAPPER on pain and depressive symptoms from baseline to 12 weeks (compare intervention to wait list 
control group) and then at 24 weeks to compare the intervention group to wait list control group once again, 
2) estimate preliminary effect sizes for DAPPER in reduction of frailty, and 3) measure effect sizes and 
feasibility of measuring cytokines.    
 
This study is being supported through funding from the Harold Amos Medical Faculty Program and the 
Johns Hopkins Older Adults Independence Pepper Center.  
 
 
 

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
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3. 
Background 
 
BACKGROUND AND SIGNIFICANCE  
 
African American women experience higher rates of comorbid conditions and related health consequences 
than other racial/ethnic groups.  1,2 Among the health consequences that African American women 
differentially face are pain, depressive symptoms, and frailty.  Pain, depressive symptoms, and frailty can 
occur in a multi-directional cycle. 
 
Pain and Depression  
Pain and depression frequently co-occur among older adults with comorbidities and can exacerbate one 
another; 3treatment is needed to avert frailty, disability, and mortality. 4, 5 In older adults it can be difficult 
to treat both pain and depressive symptoms.  Older adults are not only at high risk for side effects from 
pharmacological interventions but also often don’t experience full relief from them; 6 hence, it is vital that 
non-pharmacological mechanisms are developed to treat the pain-depression cycle among older adults.  
 
The intersection of race, gender, and age put older minority women at an increased risk of experiencing 
undertreated depressive symptoms and pain that can significantly diminish their quality of life. 7, 8 
Depressive symptoms among African Americans are more severe than other racial/ethnic groups.9 
Although half of adults with depressive symptoms undergo treatment, only 45% of African Americans with 
depressive symptoms undergo treatment.9 African Americans experience higher rates of pain10,11 and are 
prescribed pain medications less often than non-Hispanic Whites.7 Some antidepressant medications, 
opioids, and NSAIDS can improve depression and decrease pain among older adults/older African 
Americans; however, they may experience high rates of side effects from these medications.12Hence, non-
pharmacological pain interventions can be combined with pharmacological interventions13to help alleviate 
pain and depressive symptoms in older African American women.  
 
Frailty and Pain  
African American women experience higher rates of disability and frailty than non-Hispanic Whites or 
African American men. 2,14,15 Among many potential mechanisms underlying this disparity, pain is a factor 
that is amenable to interventions.  16-18 Frailty increases the perils of experiencing chronic pain; 17,19,20 
whereas, chronic pain can contribute to frailty by increasing a risk of decreased activity and gait speed.  21-23 
Pain has been identified as a modifiable factor that may improve frailty, if addressed. 24 Pain management 
in older frail women improves quality of life. 20  
 
Frailty and Depression  
People with depression are at a fourfold increase of experiencing frailty. 25 Increases in both frailty and 
depression are related to higher odds of nursing home admissions and higher risks for falls. 26 Depressive 
symptoms may impact activity levels, energy, and nutrition, which all play a role in the etiology of frailty. 
Depressive symptoms may be a modifiable factor that could have an impact on frailty in older African 
American women.   
 
Older African American women are crucial to target for intervention not only because of their heightened 
frailty prevalence, but because they are at higher risk of pain than other racial/ethnic groups and African 
American men. 10,11,27,28 Additionally, the relationship and outcomes of pain, depressive symptoms, and 
frailty are exacerbated in older women. 29.  
 
Gaps in the Literature Addressing Pain, Depressive Symptoms, and Frailty  

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
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Communication:  According to research, African Americans experience difficulties in communicating 
with their health care providers. 30-32  Ghods and colleagues reported that among 109 adults with depressive 
symptoms, African Americans had less rapport building with their health care providers and less depressive 
symptom related statements than non-Hispanic White counterparts. 33 In another study, researchers 
identified that among African American and non-Hispanic Whites with musculoskeletal pain that 
discussions about pain with their primary health care were sparse and communication about chronic pain 
was often challenging.  34 Hansson and colleagues (2018) conducted focus groups with health care 
providers and identified that there were challenges in communication among health care providers and frail 
older adults. 35Interventions that include coaching and education strategies that target communication can 
be effective in improving communication between African Americans and their primary health care 
providers. 30,36 Studies show that a communication intervention has the potential to improve patients’ 
communication with health care providers 37 and results in better health management. 38  
 
Non-pharmacological Strategies: There is limited data on culturally appropriate, non-pharmacological 
strategies to manage depressive symptoms, pain, and frailty within older African American women. To our 
knowledge non-pharmacological studies targeting pain have not shown significant improvements in 
African Americans, 39 or showed improvement in depression but had small numbers of African Americans 
in the sample. 40   
 
Self- Management Interventions: Self-Management interventions have been successful at addressing 
conditions such as depression and physical function among older adults. Self-management is defined as the 
tasks or strategies that are conducted within the living environment that promote health by addressing 
conditions or symptoms across five core areas: problem solving, decision making, resource utilization, 
partnerships with healthcare providers, and taking action. A self-management behavioral activation 
intervention that has effectively treated depressive symptoms in older African Americans is the Get Busy 
Get Better/Beat the Blues intervention (NIMH, RO1 MH 079814, PI :Laura Gitlin).  41,42 Get Busy Get 
Better included 208 community dwelling African Americans with depressive symptoms in Philadelphia. 
The intervention included up to ten visits by licensed social workers over 4 months.  42 The visits included 
ongoing education about depression and related treatment for depression.  42 The participants did set their 
own goals (decision making) and the education and treatment (problem solving) assisted them with 
achieving these goals.  Another intervention, the Community Aging in Place, Advancing Better Living for 
Elders (CAPABLE) study (NIH, R01-AG040100, PI: Sarah L. Szanton), is a person directed tailored 
program in which participants set their own goals (decision making) and work with occupational therapists 
and nurses (partnerships with healthcare providers)  to use individually tailored strategies  (problem 
solving) to meet their self-selected  goals. 43,44The participants select goals from areas related to physical 
function as well as pain management, depression, falls, and communication with health care providers. 
45CAPABLE shows improvement in physical function, pain, depression, and disability outcomes.  
CAPABLE has been replicated in 28 sites in 14 state including statewide in Massachusetts.  43,45 To our 
knowledge, there have been no tailored self-management person directed interventions that address a group 
of conditions such as pain, depressive symptoms, and frailty among older African American women.  
 
Development of DAPPER: Given the need for a tailored self-management intervention targeting pain, 
depressive symptoms, and frailty in older African American women, the gaps in the current literature, and 
documentation of successful interventions, we have developed an intervention. The proposed intervention 
is called Depression and Pain Perseverance through Empowered Recovery (DAPPER). We are adapting the 
Get Busy Get Better intervention by adding components (e.g. nurse visits and person directed goals) from 
the CAPABLE study for this intervention.  We will further develop the intervention through this pilot test. 
Specifically, we are using the structured visits and visit content guidelines from Get Busy Get Better. We 
are also using the model of nurse visits from CAPABLE in which the participants are universally assessed, 

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
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and their goals address the areas that are assessed. In DAPPER, the participants work with nurses to 
incorporate strategies surrounding communication with health care providers and non-pharmacological 
strategies that will help them meet their identified health goals surrounding pain and depressive symptoms. 
Through addressing these goals, we hope to impact frailty outcomes. Given the participants may have 
different types of pain and severity of depressive symptoms they will need individualized goals and tailored 
strategies to meet their goals. The structure of the intervention, number of visits, and content of each 
visit remains the same across all participants. We have seen this model prove successful in the 
CAPABLE study.  43,45  
Investigators: 
The PI (Dr. Taylor) has had training in intervention research and has experience recruiting and conducting 
research in minority women aging with chronic disabling conditions. 46,47 Dr. Szanton (Co Investigator) was 
the principal investigator for the successful CAPABLE intervention43, which is being used across the 
country and in Australia.  Dr. Szanton now oversees the translation of CAPABLE and is involved with 
several other funded intervention clinical trials. Dr. Szanton has served as Dr. Taylor’s post-doctoral 
mentor and now is her formal faculty mentor.  Dr. Melissa Hladek (Co Investigator) has expertise in 
biomarkers and stress.  She will conduct all training on the heart rate variability measures and will be 
analyzing data related to heart variability.  She will also assist with data storing, handling, and analysis of 
cytokines.  The data analyst will be a member of the Johns Hopkins School of Nursing Center for 
Innovative Care in Aging.  They will assist with randomization, data management, and data analysis 
throughout the duration of the study.  Dr. Jin Joo will serve as a consultant on the study.  She is a 
psychiatrist with expertise in depression in older African Americans and minorities.  We will consult Dr. 
Joo regarding any participants with severe depression and/or suicidal ideations.  
 
Approach  
 
4.a Theoretical Framework:  Self-regulation theory is the theoretical framework for this study.  Self- 
regulation theory involves two tenets: 1) participants manage their response based on their experiences 
(experiences with pain, depression, and frailty treatments) and knowledge of an event and 2) participants’ 
goals are to maintain comfort and decrease the negative effects of an illness (pain depression and/or frailty) 
on their lives. 48,49 The intervention is participant centered and participant driven.  This means that the 
participants’ experiences and existing knowledge about pain, depressive symptoms, and frailty will drive 
the goals that they set.  For example, a participant may have experienced pain, depression symptoms, and 
frailty; she is no longer able to go work in her garden.  Her goal may be to be able to garden again.  This 
would provide comfort, decrease the effects of these three conditions, and potentially improve her 
symptoms.  
 
Design overview of the study:   The design of the study 
is outlined in the above figure.  The outcomes will 
determine effect sizes on the intervention’s effect on pain 
and depressive symptoms.  Outcomes will be measured 
at 12 weeks (compare intervention and wait list control 
group) and at 24 weeks (look at outcomes for wait list 
control group and outcomes over time for intervention 
group).  Goal attainment will be measured at 12 weeks 
and 24 weeks.  At 24 weeks, we will also conduct virtual 
semi-structured one on one individual interviews with 
participants to determine feasibility and acceptability. 
The intervention group (n=30) will start the study and will receive eight nurse visits that will be focused on 
decreasing pain, depressive symptoms, and meeting participant selected goals set in these areas.  The wait 
list control group will receive monthly calls by a study team member to ensure their contact information 

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
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has not changed.  Data collection, nurse visits, and interviews will be completed via Zoom video calls.  
Zoom is a HIPAA compliant virtual meeting software used for telehealth purposes. The study will include 
either in person or virtual visits depending on the preference of the participants. The study team completing 
in person visits have all been fully vaccinated and will wear personal protective equipment at visits. In 
addition, study team will screen all research participants for symptoms of COVID based on the Johns 
Hopkins University of Medicine including fever, cough, sore throat, shortness of berath, acute loss of tase 
or smell, headache, vomiting or nausea, new fatigue or runny nose in the last 72 hours. The study team will 
reschedule if participants exhibit any of these symptoms at a later date when participants are symptom free 
for 72 hours or have a negative Covid-19 test.  
 
DAPPER Protocol 
 
 
Inclusion/Exclusion Criteria 
 
Inclusion criteria: 1) self-reported pain >3 out of a 0 -10 scale that has lasted longer than 3 months and  
keeps them from doing at least one activity that they would like, 2) Self-Identify as African 
American/Black female 3) non-institutionalized and living in the community Maryland, Virginia  or 
Washington DC area.  4) score a 5 or higher on the PHQ9 (depression measure) at least two times during a 
two week period (screening call and then at first data collection visit via video), 5) pre-frail ( one or two 
criteria on frailty phenotype) or frail (three or more of the criteria on frailty phenotype), 6) at least one 
ADL or IADL limitation    Exclusion Criteria: 1) Hospitalized > 3 times in the last year, 2) participating in 
physical therapy, 3) have a terminal diagnosis (<1 year expected survival),  4) > moderate intellectual 
impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMSQ), 5) Unable to 
understand or speak English 
 
We will recruit participants from the PI’s Communication Behaviors and Development of Pain and 
Depression Intervention among Older African American Women (IRB000170533) study.  This study 
consisted of focus groups for the development of the DAPPER intervention.  We will only contact 
participants who agreed to be contacted for future studies.  We will contact these participants by phone and 
ask them if they are interested in participating in the intervention (please see the phone script).  If 
participants agree to this, we will screen them on the phone at this time. 
 
 Recruitment will also be conducted via mass marketing.  A study team member will identify organizations 
(e.g. churches, senior high rises) that have established partnerships with the Johns Hopkins School of 
Nursing Center of Innovative Care in Aging, the Johns Hopkins Center for Health and Aging, and the Johns 
Hopkins Geriatric Services Frailty registry. The study team will provide each site (Maryland AARP, senior 
high rises, African American hair salons, etc.) director with flyers.  We will send the flyers via email to 
distribute on social media sites or distribute to mailing lists.  We will send messages through Johns 
Hopkins MyChart for recruiting to patients who have demographics that match the study inclusion criteria. 
We will not send recruitment messages to individuals who have opted out of receiving them.  We will also 
provide flyers to health care providers of older adults and/or chronic pain patients. We will also use “Word 
of Mouth” campaigns – volunteers & ambassadors, clinics, and personal contacts.  The potential 
participants will be instructed to contact the research team if they are interested in participating in the 
research study.  A study team member will screen the potential participant and explain the study over the 
phone.  If the individual is eligible a study team member will arrange a video visit to re-screen, explain the 
study again, ask the participant understanding of the study, and give them an opportunity to ask 
questions.  If the potential subject wishes to participant, the study team member will obtain consent either 

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
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by delivering the consents as a hard copy or via  DocuSign and conduct the baseline questionnaire. If 
participants do not do a Docusign consent we will use the following process:  
• 
After the consent designee and participant or LAR review the consent form, the participant or LAR 
is offered the opportunity to ask any questions and have those questions answered. 
• 
The participant (or LAR) will sign and date/time the paper copy of the informed consent document. 
• 
The consent designee must verify the participant or LAR physically signed the consent document 
either by viewing via video conference, obtaining a photo of the complete signed consent document; 
or obtaining verbal confirmation from the participant that she signed the consent form or agreed to 
participate electronically. 
• 
The signed document is then mailed, emailed, photo/scanned to text or faxed to the consent 
designee. 
• 
If the signed consent is provided as an electronic copy (dropped off at their place of residence) 
emailed ,photo/scanned to text, or faxed), the participant or LAR must return the original signed 
document on their first in person visit or by mail if there is no in person visit. 
• 
If the signed consent form is mailed to the consent designee by the participant or LAR, The IRB-
approved consent designee will sign their copy which they possess after the participant has 
acknowledged signature on their copy. Once the participants original copy is received the consent 
designee copies will be attached to make a single document. 
• 
If the participant signed consent form is provided immediately by electronic format (emailed, faxed 
or photo/scanned to text, once received, the IRB-approved consent designee signs, dates/times this 
informed consent document. 
 We will provide participants with password protected ZOOM links for all meetings.  
We will distribute flyers to the Maryland AARP, senior housing residents, African American hair salons, 
and on Facebook local group and organization sites.  A study team member will obtain necessary 
permission from administrative staff at all locations before any flyers are distributed via postal mail or 
email.  
We will randomize participants to each group with the following process.  1) Once we find 
potentially interested participants through the above referral sources, we will telephone screen for 
eligibility and explain study procedures.  2) If eligible by phone, the research assistant will re-screen, re- 
explain the study, obtain consent (via DocuSign or hard copy ), and conduct the baseline data collection. 4) 
If participants qualify for the study after this visit, within 48 hours of the baseline interview, we will 
randomize using a computer-based assignment scheme and communicate the assignment to participants by 
letter.  An employee of the Johns Hopkins Center of Innovative Care in Aging will be unblinded and will 
complete the randomization for the project.  5) The person assigned to randomize will inform the nurses of 
the participants’ group (intervention or control).  7) The nurses will contact the participant within one week 
to schedule the first appointment.   
 
          The wait list control group will have data collectors schedule a Zoom video visit with them. The 
same data will be collected for the intervention group.  Participants in the wait list control group will not 
start the DAPPER intervention until the intervention group has completed the study. The wait list control 
group will receive monthly phone calls to confirm contact information.    
 
 
Data Collectors:  The data collectors have been trained to obtain baseline and outcome measures of each 
participant.  The data collectors will collect baseline and outcome data and are responsible for teaching the 
participants how to collect saliva samples. The data collectors will call participants to schedule the first 
Zoom video call.  The data collector will call/log on at the mutually agreed time.  The data collector will 
complete the questionnaire booklet with the participant and complete the frailty phenotype measurements 

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
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with the participant.  If the participants meets the criteria for frailty, pain, and depression, enrollment in the 
study will continue.  Upon completion of the nurses’ visits, the data collectors will schedule a final visit 
with participants.  
 
Research Nurses: An RN is the appropriate professional to conduct the visits because of the training in 
assessment skills, and knowledge base in physiology, medications, and patient education in pain and 
depressive symptoms. 50 The nurses have been trained on the protocol.  The nurses will call the participants 
to schedule the first visit.  The nurses will meet with participants via Zoom video calls during a mutually 
agreed upon time.  The nurses will work with participants to set goals surrounding pain and depressive 
symptoms.  The goals will be participant driven and documented by the nurse.  The nurse will then work 
with the participant to identify strategies to work on three goals.   
 
Visits 
 
Data Collection Visit One:  The data collector will  call or do video visit with patient in order to re-screen 
for criteria to be in the study.  If participant meets criteria, the data collector will have participant sign a 
consent form.  
We will be using DocuSign, the Institution’s approved and 21 CFR Part 11-compliant software, to obtain a 
secure electronic signature.  Once the IRB approves our consent form(s), we will use the IRB-approved 
consent form(s) as the base for the DocuSign template. The IRB-approved document will not be altered 
other than to overlay locations where signatures, initials, dates or other DocuSign fields will be added to 
create the study-specific DocuSign template.   
We will send the consent to the participant via DocuSign, providing a participant-specific code in advance 
of sending the document via DocuSign, that will be required when the participant accesses and signs the 
consent. The consent discussion may take place via phone or video conference (e.g. Zoom).  Participants 
will be given adequate time to consider the research study and ask questions prior to signing the consent 
form.  When ready to sign, the participant will enter their code, verifying that the person signing the 
consent is the person that we spoke with previously, and sign the consent within the DocuSign system.  
(Note: For studies requiring multiple signatures, e.g. two parental signatures or if a witness is required, all 
individuals will receive codes in order to sign).  Once the participant has electronically signed, the study 
team member obtaining informed consent will be notified that the electronic form is ready for his or her 
signature.  Once signing is completed by all parties, both the study team and the participant can download 
the signed consent as a PDF.  The study team will also have access to the audit log and the Certificate of 
Completion.  The study team will load the signed consent into Epic. 
After the informed consent process is completed, the IRB approved study team member files the consent 
document in the research record, including a note confirming the consent process. The data collector will 
verify if the participant has any questions regarding the consent form and verify the participant understands 
the consent form. The data collector will ensure that the participant reads the consent form and has a copy 
of the consent form.   After the consent is completed, a formal assessment of outcomes will be done.   The 
data collector will explain the process of saliva sample collection to the participant. We will not collect 
saliva samples from participants outside of Maryland.  A kit will be dropped off to the participants with 
non-contact either at their door or given to front office.  We will call and confirm participants receive the 
kits.  The participants will be asked to store samples in their home refrigerator.  If there is not a working 
refrigerator, the participants will be provided with a cooler and ice packs that will be replaced over the two 
days.  When the participant is ready for the saliva sample to be picked up, they will notify us, and it will be 
picked up using protective gear (gown, gloves, and mask) without contact with participants and stored in 
the Johns Hopkins School of Nursing lab.  
 
 
Final Data Collection Visit:  At this visit, the data collector will enact the same protocol as at baseline.  

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
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Saliva Sample Visits: A member of the research staff will contact the participants to ask them a good time 
to pick up samples.  The research staff member will arrive to participants home to pick up samples. 
Personnel picking up the samples will notify participants when they are arriving, and participants will place 
the sample outside the front door once the staff member pulls up or walks up to their home location.  The 
staff member will label the specimens and take them directly to the Johns Hopkins School of Nursing 
refrigerator.  Please see specifics below (laboratory studies) for further information about the collection and 
storage process of the saliva samples.  
 
Nurse Visit One: The first nurse visit via Zoom video/call will consist of the nurse conducting an 
assessment of the participant’s mental and physical health.  The nurse will conduct education on depressive 
symptoms and pain.  A booklet on both depression and pain will be left with the participant (see the 
intervention manual).  This will be emailed or mailed to participants.  Next, the nurse will assist the 
participant to set goals surrounding pain and depressive symptoms, and determination of 51, 52strategies to 
be practiced for the next six visits.  
 
After the participants have selected the goals the nurse will work with them to develop a plan of strategies. 
The strategies that the nurses will offer to work on with the participants will be evidenced-based and 
specifically target goals surrounding pain and depressive symptoms.  For example, if a participant identifies 
she has arthritic pain the nurse would offer strategies effective for this type of pain such as heat therapy.  If 
the participant agrees to this strategy, the nurse will identify the safest mechanism of heat therapy (e.g. 
warm gel packs) for the participant.  The nurse would identify any contraindications (e.g. diabetic 
neuropathy).  If no contraindications are identified, the nurse would purchase the gel packs using the 
funding for the study and would  mail the packs to the participants.  The nurse would teach the participant 
how to use the gel packs and then use the teach back method with the participant to ensure they know how 
to use them safely.  This would be done via video visit.  The participant would be able to call the nurse or 
PI with any questions or difficulties using any of the strategies.  Examples of the strategies we plan to use 
include heat packs, tai chi exercises, 53,54 breathing exercises55, and training in communication with health 
care providers56,57 surrounding pain and depressive symptoms.  The strategies will be individualized to 
meet the goals of the participants; however, the fidelity of the intervention will be maintained by the nurses 
being consistent in how the intervention is delivered and the structure of the visits.  All participants will 
also have the same outcome measures.  
 
 
Nurse Visits Two and Three: The next two visits will consist of the nurse working through each of the 
strategies. The nurse will discuss strategies with participants via video visits. The nurse will tailor the 
strategies and teach the participant the strategy at visits two and three.  
 
Nurse Visit Four: At visit four the nurse will observe the participant performing the strategies (e.g. 
completing exercises in the home), discuss how the strategies are going, and reevaluate goals. Any 
accommodations or changes will be made at this visit. 
 
Nurse Visit Five: At visit five the  nurse will observe the participant doing strategies and assist with any 
changes.  
 
Nurse Visits Six and Seven: At visits six and seven the nurse will evaluate the participant working on 
strategies and remind them of their goals.  
 

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
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Version 3 Dated:   06/2007 
 
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Nurse Visit Eight: At visit eight the nurse will conduct a final assessment and goals will be assessed at that 
time. The nurse will reevaluate the goals with participants and ask them if they believe they met their goals, 
why or why not.     
 
Measurements:  We chose measures based on our experiences in community-based trials as well as those 
that met the following criteria: 1) possess known reliability and validity with older samples; 2) are sensitive 
to change from an intervention; 3) represent objective as well as subjective indicators of the domains we 
seek to impact.  Finally, we sought to achieve a balance between psychometric quality and practical 
considerations such as respondent burden.  Table 1 shows the instruments that will be used to measure 
outcomes. 
 
Table 1- Instruments Measuring Main  Outcome Variables  
Outcomes 
Instruments 
Cognition (see 
inclusion/exclusion 
criteria)   
Short Portable Mini Mental Status Exam 58 
Depressive 
Symptoms 
Patient Health Questionnaire 9 and Patient Reported Health Outcomes 
(PROMIS) 57 59,60 
Pain  
PROMIS Pain Interference,  Pain Intensity and Pain Behavior  61,62 
Communication  
Patients’ Reaction Assessment63 
Comorbid 
Conditions  
Charlson Comorbidity Index 64 
ADLS/IADLS  
Katz 65 
Frailty   
Frailty phenotype 66 
 Frail Scale 67 will be used to measure frailty.  
Stress 
Perceived Stress Scale 67 
Self-Efficacy  
Coping and Self-Efficacy Scale 9 
Readiness to Change  Gitlin and Rose’s Readiness to Change Rating System (Gitlin  & Rose, 
)  
Social Network 
Scale  
Lubben Social Network Scale  
IL6 
Saliva Sample 
TNF α 
Saliva Sample  
IL8 
Saliva Sample  
IL-1 β 
Saliva Sample  
 
 
Goal Attainment  
Subjective Report  
 
 
 
The following instruments and a demographic questionnaire (e.g. age, SES, and education) will be 
administered to the participants’ pre- and post-intervention.  
 
Outcomes:  
Depressive Symptoms:  During the delivery of this intervention, we will use two instruments the PHQ 9 
and the PROMIS.  We will use the PHQ 9 to measure depressive symptoms.59 The PHQ9 includes 9 
questions related to the DSM diagnostic criteria for major depression. 60 We will also use the Patient 
Reported Outcomes Measurement System (PROMIS) 57, which is an 8-item instrument that can be used to 
measure self-reported negative mood, view of self, and somatic symptoms.  Utilizing both measures will 

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
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ensure we obtain an in-depth measure of depressive symptoms in our sample.  These instruments that are 
easily transferrable to the clinical setting.1 
 
Pain: Pain interference will be measured using the PROMIS Pain interference scale, which consists of six 
items from the PROMIS short form on pain interference.61The scores range from 6-30 with higher scores 
indicating more pain interference.  Pain intensity will also be measured using one item from PROMIS Pain 
Intensity Instrument.62 Scores range from 0-10 and higher scores indicate more intensity.  The PROMIS 
pain behavior scale is used to measure self-reported external manifestations of pain.71 The scores on 
PROMIS Pain Behaviors scale can range from 7-42 with higher scores indicating more pain behaviors.  
 
Communication: The participants’ perceived abilities to initiate communication with their primary health 
care providers will be measured using the Patients Reactions Assessment (PRA).63 The PRA is a 15-item 
instrument used to measure the quality of patients’ relationships with their health care providers and 
includes a subscale on the ability to initiate communication.  The subscale on the instrument that measures 
perceived ability to communicate will be used; scores can range 0-35 with higher scores indicating higher 
perceived ability to communicate.  
 
Comorbid Conditions: We will measure comorbid conditions with the Charlson Comorbidity Index.3 The 
Charlson comorbidity index consists of 17 categories of chronic conditions including two subcategories for 
diabetes and liver disease.  Comorbidities are based on mortality risk and severity of the disease; the scores 
for each disease range from 1-6.  A final Charlson Comorbidity Index score is compiled; scores greater 
than or equal to five indicate more chronic conditions and increased risk of mortality.   
 
Physical Function: Physical function will be assessed by measuring ADLs Katz ADL and Lawton’s IADL 
measures.65,73On Katz’s ADLS scores range from 0-6 with 6 indicating full function and a score of 2 or less 
indicating sever functional impairment.  On Lawton’s IADL instrument scores range from 0-8 and higher 
scores indicate better physical function. 74 
 
Frailty will be assessed by the physical frailty phenotype (includes gait speed, grip strength, BMI, and 
measures of physical activity and exhaustion).66 The frailty phenotype is used to determine if a person is 
robust (score of 0), pre-frail (score of 1 or 2), or frail (score of 3-5). The Frail Scale will be used to measure 
frailty for virtual data collection visits.67 The Frail Scale asks self-report questions about fatigue, resistance, 
ambulation, illnesses, and loss of weight.  
 
Stress will be measured by perceived stress as it often accompanies depression and/or pain.  We will 
measure using the perceived stress scale.68 The scores can range from 0-40; higher scores indicate more 
perceived stress.  
 
Self-efficacy is a large part of self-regulation.  We are going to measure self-efficacy using the coping and 
self-efficacy scale.68 The scores range from 0-26 with higher scores indicating more self-efficacy.  
 
Readiness to change will be used to identify participants’ readiness to change.  The levels include 1-pre-
contemplation, 2-contemplation, 3- preparation, and 4- action and maintenance.  This will allow the nurses 
to identify where participants are on this scale and determine if strategies or goals need to be adjusted or 
reevaluated based on readiness to change scores.  
 
Social Networks may be related to depressive symptoms and/or stress.  We will measure social networks 
through the Lubben social network scale, which identifies social engagement with both family and friends. 
The scores can range from 0-60 with higher scores indicating more social engagement.  
 

Date:  09/17/2024   
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There is a growing body of literature demonstrating the relationship between inflammatory cytokines with 
pain, frailty, and depression.  For example, inflammatory cytokines may play a very crucial role in pain 
transmission pathways.74,75 Studies have shown a link between frailty as well as pain with IL-6 and Tumor 
Necrosis Factor Alpha.76-78 The release of pro-inflammatory cytokines can lead to neuro inflammation, which 
can contribute to depression.79,80  
 
We describe the cytokines we will measure below:  
 
Interleukin-8 (IL-8): IL8 is a pro-inflammatory cytokine that is a used for neutrophil recruitment.  It may 
increase with pain and depression.  
 
 Interleukin - 1β (IL- 1β) IL 1β is a pro-inflammatory cytokine that affects cell vial binding cell surface IL-
1R1 receptor.  It increases neuronal excitability and may increase with pain and frailty.   
 
Interleukin -6 (IL-6)is a pro-inflammatory cytokine that functions in inflammation and maturation of B cells.  
It is associated with an increase in pain, frailty, and depression.  
 
Tumor Necrosis Factor-Alpha (TNF-α) is a pro-inflammatory cytokine which stimulates the NF-kB 
signaling pathway resulting in down-stream IL-6 production.31 It is associated with an increase in pain and 
frailty.  
 
Goal Attainment will be measured by asking participants if their goals are not met, partially met, or fully 
met.  We will evaluate goal attainment at nurse visit five as well as the final visit (nurse visit 8).  
 
Biomarker  Procedures:  
 
Salivary Biomarkers Specimen Collection: At the first data collection visit and last data collection visit, 
participants will complete saliva collection. Instructions will be given via phone or video. Then the 
participants will collect the samples themselves.   Universal precautions will be used when handling salivary 
samples.  Participants will be instructed to imagine they are chewing a favorite food, slowly moving their 
jaws in a chewing motion.  While doing this, saliva will pool in their mouth.  Next, they will gently force the 
specimen through a short plastic drinking straw into a vial.  This passive drool method has been used 
extensively and has several advantages over a method including volume and less interference with salivary 
glands.63 Careful instruction will be given with return demos at the first data collection video/phone visit and 
reminder instructions at the last data collection visit.  Participants will be encouraged to collect specimens 
the next two days.  Each participant will receive a set of pre-labeled, color-coded salivary sample collection 
tubes, and a similarly color-coded instruction sheet for sample collection times, either via mail, or drop-off 
at their door using no contact.  Samples will be stored in a provided bag in the patient’s freezer.  Once the 
participants have completed the samples a study team member will contact them within 48 hours to schedule 
a pickup of the samples.  Specimens will be picked up by the trained study staff using protective equipment 
including gloves and masks, then transported in a designated cooler to the lab facilities at Johns Hopkins 
University School of Nursing.  Samples for salivary biomarkers will be placed into separate tubes and labeled 
for freezing at -80°C until batch assayed in duplicate for the respective measurements.  Saliva samples will 
be measured using enzyme immunoassay (EIA) kits from Salimetrics (St. College, PA).  A research assistant 
or the PI will pick up the samples and store in the appropriate freezer at the Johns Hopkins School of Nursing.  
Samples will be clearly labeled.  After all participants have completed each saliva specimen collection (first 
and last visits) the specimens will be mailed via overnight service to Salimetrics to run in lab.  
 
Commercially available kits will be used for batch assay and each assay will be performed in duplicate. 
Duplicate assays that demonstrate a coefficient of variation greater than 15% will be reanalyzed.  All data 

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
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will be de-identified.  The sample will be identifiable by a unique generated code.  The lab will be blinded 
and will not have information that could link the generate code to the study participant.  Only the PI will 
have information that will link the unique generated code to the study participant.  
        Bio specimens for the study will be stored at Salimetrics Laboratory.  Salimetrics Laboratory supports 
protocols by providing facilities, technical experience, and training for non-routine blood and urine 
biochemical analyses.  Salilmetrics will also provide necessary kits for the saliva collection.  After the 
saliva  analysis is completed and analyzed (~2 years), we will evaluate whether to continue to store the 
specimens for an additional 3 years or to destroy them.  If we decide to destroy the samples at the end of 
this period, the lab will thaw out the samples and pool them together, then dilute the sample with a bleach 
solution. This study does not plan to share the bio specimens with other investigators. 
 
Participants will be able to withdraw consent to use their bio specimens, by contacting the PI and putting 
their request in writing.  If a participant decides to withdrawal consent, the PI will contact the lab and the 
sample will be destroyed as described above. 
 
.          
 
Fidelity Plan: The fidelity plan is based on the NIH Behavior Change consortium developed by national 
leaders.  All of the nurses and data collectors have received training for the Beat the Blues/Get Busy Get 
Better Dapper Adaptation Protocol.  They have all received training on how to measure frailty using the 
frailty phenotype.  We will enhance fidelity through design elements (intervention is distinct and based on 
theory), training (using an intervention manual and having formal training), delivery (reminder calls the 
night before intervention sessions, measure fidelity through records of home sessions (by date and 
duration), checklists completed by study team members, direct observations concerning intervention 
engagement to evaluate receipt, and enactment (e.g. participants will show the exercises to the nurses).  Ten 
percent of sessions will be audio taped which will be reviewed by the principal investigator using 
monitoring checklists developed for this pilot trial.  The recordings will not be transcribed.  When video 
visits are done the recordings will be recorded via digital recorder and not via the ZOOM recording feature. 
Feedback will be provided to each interventionist who will provide case presentations in supervisory 
sessions.  Bi-weekly meetings with the data collectors, registered nurses, and the PI.  
 
 
Data collection and management: We will use the Redcap data entry and management system, which is 
available to all Clinical Translation Science Award (CTSA) sites such as Johns Hopkins University.  Data 
from screening, intervention sessions, and final data collection will be entered onto forms that the data 
manager will check for completeness and appropriateness.  The data manager will send reports of missing 
or inappropriate entries to the PI every week for clarification and resolution.  The details of the Data Safety 
and Monitoring plan are in the human subjects section.   
 
Acceptability Qualitative Interviews: Upon completion of the intervention, the follow up interviews will 
be scheduled with 10 randomly selected participants from both the intervention and wait list control groups.  
These interviews will be done by a study team member.  The interviews will be scheduled and completed 
with participants via phone or video.  We will ask their thoughts on the intervention and ask for what 
worked and what did not.  The interviews will be audio recorded with a digital recorder only.  We will 
make sure that all information is in a locked file cabinet at Johns Hopkins School of Nursing.  We will keep 
all audio recordings separate from documented person information.  We will ask participants to avoid using 
names in the interviews.  The audio recordings will be stored on an encrypted computer after the interviews 
are completed.  The PI will review all transcripts and work with study team to identify themes surrounding 
intervention changes and conduct intervention mapping to refine the intervention for the next grant 
application.  The audio recordings will be stored on an encrypted computer after the interviews are 

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
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completed.  Production transcripts will transcribe the follow up interviews.  The PI will review all 
transcripts and work with study team to identify themes surrounding intervention changes and conduct 
intervention mapping to refine the intervention for the next grant application.  
 
As a additional portion of the study upon completion of the last data collection visit, we would like to call 
all of the participants who completed the intervention and verify their contact information in order to send 
them a handout with the study findings. We will verify their address/email  and ask if they would like to 
receive the findings. In addition, we would like to ask participants follow up questions about their 
participation in the study (please see attached post follow interview guide). Follow up questions will also 
include acceptabilityand satisfication questions in goal attainment. We will also obtain consent for these 
interview questions using the attached  consent script that we will verbally read to them. These interviews 
will take place via zoom,  or telephone and will be recorded with a digital recorder. We will give 
participants the opportunity to send photos of any goals or changes that were made after completing the 
study. We will only use recordings for purpose of analyzing goals data and follow up questions. All 
recordings will be deleted after one year and stored on our encrypted server. Photos will not include any 
participant identifiers and photos and will not be used for dissemination of findings.. 
 
 
4. 
Drugs/ Substances/ Devices 
 
N/A 
 
5. 
Study Statistics 
 
Sample size calculation and analysis of aims  
 
Sample size: To calculate effect sizes for planning a definitive trial our sample size calculations were 
based on the need to pilot DAPPER for pain and depressive symptoms.  We assume an attrition rate of 13% 
during the 16-week follow-up based on the CAPABLE trial.  Based on these assumptions, an initial sample 
size of 64 participants (3 , 32in the intervention group and 32 in wait list control) would yield 52 
participants (25 intervention, 25 wait list control) after attrition.  It is unlikely we will detect a significant 
difference between the groups due to small sample size and limited follow-up.  
 
Analytic approach:   
For DAPPER, the outcomes will be improvement in pain, depressive symptoms, and communication with 
health care providers.  A database will be created and stored on a password protected encrypted 
computer.  Prior to conducting the analysis, the distribution of the data will be examined to 
determine if they meet the assumptions of the analytical model and to explore the pattern of 
missing data.  The number of sessions attended will be computed as an indicator of acceptability. 
To test the effect of the intervention on outcomes (depressive symptoms, pain), generalized 
estimating equations will be used (GEE) with time, group, and the time x group interaction.  We 
will not be sufficiently powered to detect a significant effect; interpretation of the results will be 
based on the effect size associated with the time by group interaction for each outcome.  One 
advantage of GEE is it allows all participants’ data to be included in the analysis, even those who 
do not complete the study, providing an intention-to-treat analysis.  We will also conduct 
sensitivity analyses with completers only and compare the effect size to the ITT analysis to 
estimate the effect size when all participants adhere to the intervention. 
 
Acceptability of the intervention will be examined in multiple ways.  We will examine percentages of 
people who stayed in each arm of the study and conduct numerous descriptive correlational analyses of the 

Date:  09/17/2024   
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Application Number: IRB00226182 
  
 
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association between the intervention compliance and other variables.  These analyses will quantify 
intervention implementation by demographic and participant health variables.  Analyses that utilize the 
post-randomization data (e.g. treatment compliance) 40-43 will be evaluated in supplementary analyses.  We 
will distinguish non-compliance with intervention from attrition or loss to follow-up, i.e. missing data.  We 
will also use the one-on-one qualitative interviews to examine acceptability of the intervention. 
 
 
6. 
Risks 
 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
Minimal risks to study participants are expected.  There is a chance participants may experience some 
discomfort, or fatigue in completing saliva specimen collections.  Participants may become fatigued or 
emotionally distressed while completing battery of questions.  When performing the frailty phenotype 
walking speed tests participants may stumble, fall, or become short of breath or fatigued.  If strategies 
include any type of physical activity (e.g. tai chi exercises) participants may become short of breath, 
fatigued, or may experience pulled muscles or dizziness.  
b. Steps taken to minimize the risks. 
Participants can decline the saliva specimen collection or stop collecting specimens at any 
time. Participants can decline saliva collection or stop at any time. Participants can also 
decline to answer any of the survey questions.  Research staff has been trained to interact with 
participants in a positive, non-judgmental manner that encourages honest communication and 
a partnership approach to study participation.  Participants may decline the walking speed test, 
or any exercise strategies suggested by the nurse.  The nurses have the necessary training to 
recognize respiratory distress and how to reduce falls (e.g. removal of clutter, assessing for 
dizziness and balance) via Zoom. The principal investigator will be made aware of any adverse 
reactions or events.  Participants will receive a follow-up telephone call to assure that the 
reaction/event has resolved.  If the reaction/event persists, a referral will be made to the 
participant’s primary care provider for further evaluation.  
 
 
 
Procedures for protecting against and minimizing potential risks:  
 
If any physical problems emerge during any of the home visits, immediate medical attention will be sought 
for the participant.  The risk of invasion of privacy will be addressed with participants during the informed 
consent process.  All personnel involved in the study will be fully trained and certified in the protection of 
human subjects and HIPAA regulations. We will use a virtual video call software called Zoom.  Zoom is 
encrypted, collects no protected health information (PHI) and any data transmitted during the call is 
destroyed when the call ends.  It is both HIPAA and HITECH compliant. 
This certification will be kept current throughout the study.  As part of the informed consent process, 
participants will be notified of their rights pertaining to protected health information.  Participants will 
be informed that they can stop the questionnaire and rest at any time.  All study participants will be 
provided referral information to existing health services as in typical or usual care.  Thus, participants 
have the information to access any services that they may perceive as necessary independent of their 
study participation.  
 
The risk of breaching study participant confidentiality will be minimized by identifying all participants by code 
numbers, securing all data collected in locked files in the PI’s office, and screening information to locked file 
cabinets with limited staff access.  Pre-coded data collection instruments are prepared for use with study 
participants at each testing occasion.  Identification numbers to assure subject confidentiality will be used.  Only 

Date:  09/17/2024   
Principal Investigator: Janiece L. Taylor, PhD, RN, FAAN   
Application Number: IRB00226182 
  
 
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one master log of subject names, addresses, telephone numbers, and study identification assignment will be 
maintained in a password protected computer program.  Data collection will be on computer tablets that are 
password protected.  Audio recording of nurse visits will be routinely conducted for fidelity and quality control 
review.  These recordings will be identified by numbers only and stored in files on computers of the project 
coordinator and Dr. Taylor who will provide fidelity oversight of the interventionists.  Access to these computer 
files will be password protected; recordings will not contain respondent name or other personal identifying 
information and will not be transcribed.  Recordings will be used only for quality control and training purposes 
and then destroyed (deleted from computers) within one year of trial completion.  
 
Plan for Data and Safety Monitoring:  This study is partially funded through the Older Americans 
Independent Center (OAIC) Pepper Center at Johns Hopkins University.  Data and safety reports will be 
reviewed by the OAIC Director and/or co-PI.  In the yearly progress report to NIH, the OAIC Directors 
will certify that the principal investigator has read all data and safety reports, in addition to making sure  all 
corrective actions have been taken where there were concerns and/or that no concerns were noted. 
e.2 Verification of eligibility criteria: The OAIC’S Data and Safety Monitoring Board reviews all 
applications for OAIC support that are being considered for funding.  The board will verify that the 
inclusion and exclusion criteria are acceptable, or they will recommend revisions.  
e.3 Frequency of Data and Safety Monitoring: Reports are reviewed quarterly, in conjunction with review 
of OAIC supported investigator progress reports.  The OAIC DSMB is convened every 6 months. 
Unscheduled reviews may be conducted if necessary, at the request of the OAIC Director, study PI, 
SO/DSMB, or NIA program official. 
e.4 Content of Data and Safety Monitoring Reports: Reports include, at a minimum, study status; 
descriptions of all SAEs, AEs, UPs, and protocol deviations (including enrollment of an ineligible 
participant); and any abnormal laboratory, imaging, and other test results.  The study PI will attest his/her 
knowledge to the list of SAEs, AEs, UPs, and protocol deviations completed or that no SAEs, AEs, UPs, 
and protocol deviations occurred.  
The members of the DSMB will be available to offer advice and provide ad hoc consultation throughout the 
study period.  There will be continuous investigator monitoring with prompt incident reporting to the 
OAIC, Johns Hopkins Internal Review Board, Robert Wood Johnson Foundation, and National Institute of 
Health (NIH).  Evaluation of this trial will include periodic assessments of data quality, participant 
recruitment, accrual, and retention.  All adverse events will be reported to the IRB and the chair of the 
DSMB within 48 hours if attributable to the study.  Members of the DSMB may request an interim analysis 
of data, which will be presented by the trial biostatistician in a session closed to the PI.  The minutes 
meetings of the DSMB will be reported to Robert Wood Johnson Foundation, NIH, and IRB.   
 
Adverse Event (AE) Reporting:  The DSMB will be notified by the principal investigator of any serious AE 
within 48 hours of initial notification to the project team.  All members of the DSMB will receive copies of 
all safety reports at the time of submission to the IRB.  In addition, a listing of AEs and their attribution 
(e.g., level of probability of being study related, intervention related, or unrelated to study or treatment) will 
be provided to the DSMB on a monthly basis.  We do not anticipate any adverse reactions to the 
intervention.  Based on our previous work and studies in this area by others, there is only a small risk that 
participants will become increasingly anxious to the point that it becomes an adverse event (e.g., harmful to 
self or others) as a consequence of the activity intervention or having a member of the research team in 
their home.  However, interviewers/interventionists are well trained to manage this reaction or make an 
effective referral if necessary.  
 
Given that interviews for data collection and interventions via video, there is the potential for a member of 
our research team to encounter a potential emergency that is not related to study participation (e.g., 
dehydration, environmental risk, medical emergency).  Following the emergence of the need to account for 

Date:  09/17/2024   
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such events in behavioral interventions differently than in medical/clinical studies,58 we refer to such events 
as “alerts” and have well-developed procedures for their management.  All alerts will be reported to the 
DSMB on a biannual basis.  However, the reporting of alerts to the IRB of JHU is not required (see Chart 
below of potential alert events and plan for their management and reporting). 
 
Recruitment, AE, and Alert Reports:  Reports presented to the DSMB will include data on enrollment 
(study accrual by month; comparison of expected to actual enrollment; number of individuals screened, 
number eligible and number ineligible, number randomized by gender, AEs, and alerts.  In addition, the 
DSMB will receive reports of the number of study participants who discontinue from the treatment group 
and/or the study and reasons for discontinuation.  We propose that reports are provided to the DSMB twice 
yearly.  However, the DSMB will decide upon the schedule of reports.  In addition, the DSMB may request 
reports as needed as well as the unblinding of the data should they deem this necessary.  If unblinded 
efficacy data is required, the biostatistician for this study (Dr. Zhang) will serve as a liaison between the PI, 
database, and the DSMB in order to assure that the PI and investigative team remains blinded.   
Plan for reporting unanticipated problems or study deviations:   
b.2. Protections Against Risk 
The Principal Investigator will be notified of any adverse events.  Participants will receive a 
follow-up telephone call to assure that the reaction has resolved.  If the reaction persists, a 
referral will be made to the participant’s primary care provider for further evaluation. In 
situations where there is initial severe distress or when the distress has not been resolved, if 
suicidal thoughts are present, we will immediately call 911 for further help and stay with the 
participant until help arrives.  If suicidal ideation or intent is identified, the study team 
member will follow the study’s suicide protocol.  The suicide protocol will utilize an 
adapted version of the Columbia Suicide Severity Rating Scale to assess mild, moderate 
or severe risk.  If risk is mild study team will notify PI, provide mental health resource 
guide, advice to speak to their healthcare provider.  If the risk is moderate, it will be the 
same as mild with expression of high concern and strong recommendation to seek care. 
If the risk is severe, the study team member will call 911 or suicide crisis number or 
escort to emergency room and immediately notify the PI.  We will consult with Dr. Jin 
Joo on referrals and next steps for any all mild and moderate risk patients.  Furthermore, 
if any physical problems emerge during any of the visits, immediate medical attention will be 
sought for the participant. 
If participants experience any physical problems during any portion of the study, immediate 
medical attention will be sought for the participant.  See the table below regarding alert and 
actions to be taken.  
 
Table 4  
Alert 
Action Taken 
Medical Emergency:  
• Chest pains 
• Excessive bleeding 
• Fall and cannot get up 
• Difficulty breathing 
If a member of the research team encounters any of 
these symptoms over the phone, the participant is put 
on hold and the PI will call 911 immediately.  If the 
situation occurs within the home or during focus 
groups, the PI and/or research personnel will call 911 
immediately and stay with the participant until help 
arrives.  
If participants engage in physical activity virtually, the 
nurse will assess every five minutes for shortness of 
breath or any pain at all. If participants verbalize this or 
shortness of breath is observed the nurses will ask 

Date:  09/17/2024   
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participants to stop any physical activity.  
Evidence of abuse 
Evidence of physical abuse is follows:  
• Participant states to the PI/research staff that 
abuse occurs.  
• The RN observes physical evidence (e.g. black 
eye, black and blue marks arms/legs.  
The investigators will contact participants and strongly 
encourage him/her to contact his/her primary care 
provider and/or Adult Protective Services (phone 
number will be provided).  Based on the situation, the 
PI may notify Adult Protective Services.  The PI will 
complete an alert form. Note- The possibility of 
informing an agency about an abusive situation will be 
stated in the informed consent.  
Extreme Home Hazards 
• Exposed electrical  
• External door missing or 
cannot be locked  
• Ceiling, floors caved in  
• No temperature regulation 
(e.g. no air or heat- must 
be extreme) 
• Major infestation  
The investigators will refer participants to Baltimore 
City 311 who can refer participants to possible 
resources for home repairs and/or infestations.  
 
All personnel involved in the study have been fully trained and certified in the protection of human 
subjects.  This certification will be kept current throughout the study.  Education in protection of human 
research participants: The investigators have completed the Johns Hopkins University School of Medicine 
Research Compliance course.  All research personnel on the proposed study will complete the Johns 
Hopkins University (JHU) School of Medicine Research Compliance Course.  The JHU course consists of 
the University of Minnesota Web modules on Informed Consent, the Consent Process, After Informed 
Consent, JHU School of Medicine module on local IRB requirements, and achievement of a passing score 
on the JHU Knowledge Assessment module.  According to the policies of the JHU, approval for this 
research will be obtained from the JHU IRB office for research using human subjects.  Participants will be 
assigned a code number on initial entry and only the code number will identify all subsequent 
questionnaires.  Information needed for follow-up contact (names and addresses) will be kept separately 
from all other data.  
 
Legal Risks such as the risks that would be associated with a breach of confidentiality:  
The risk of breaching study participant confidentiality will be minimized by identifying all participants by code 
numbers and by securing all data collected in locked files in the PI’s office and screening information at the 
senior center in areas with limited staff access.  Pre-coded data collection instruments are prepared for use with 
study participants at each testing occasion.  Identification numbers to assure subject confidentiality will be used.  
Only one master log of subject names, addresses, telephone number, and study identification assignment will be 
maintained on site in the locked PI’s office.  This log, in both hard copy and disk, will be stored in a locked filing 
cabinet separate from other identifying information.  All completed data collection instruments are stored in 
locked filing cabinets.  
 
Financial risks to the participants: There are no anticipated financial risks to the participants.  
 

Date:  09/17/2024   
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7. 
Benefits 
 
Potential Benefits of the Proposed Research to Human Subjects and Others 
Participants will receive study visits from a nurse and learn strategies to address pain and frailty syndrome 
as well as communication with providers.  
There are no known direct benefits to participants, but possible benefits may include that participants will 
learn strategies to help improve their symptoms related to pain and depressive symptoms.  Participants will 
also be contributing to important research that may help improve pain and depression outcomes among 
older African American women.  
 Importance of Knowledge to be gained 
This study has the potential to add to the current body of literature on effective ways to address depression, 
pain, and frailty in community dwelling older African American women.  
8. 
Costs 
There are no costs to participants for participating in the study.  We will compensate all participants, $20 
(gift cards or cash) after completion of the final visit of study.  We will also compensate the 10 
participants selected for qualitative interviews at the end of the study with $10 (gift cards or cash).  The 
funds that support the study will be used to purchase any materials for the strategies (e.g. heat therapy gel 
packs).  
 
 
N/A 
 
 
 
 
References 
 
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