HOME DM-BAT: Home-based Diabetes-Modified Behavioral Activation Treatment for Low Income Seniors With T2DM
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: State University of New York at Buffalo

Official Title: 
HOME DM-BAT: Home-based Diabetes-Modified Behavioral 
Activation Treatment for Low lncome Seniors with Type 2 
Diabetes Mellitus 
NCT number: 
NCT04203147 
Document Type: 
Study Protocol 
Date of the 
Document: 
06/02/2021 

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HOME DM-BAT: Home-based Diabetes-Modified Behavioral Activation Treatment for Low lncome 
Seniors with Type 2 Diabetes Mellitus – Study Protocol 
SPECIFIC AIMS 
Persistent disparities based on race/ethnicity and socioeconomic status in healthcare are well 
documented in the United States (IOM 2003, AHRQ 2015, Williams 2016). Social determinants of health are 
key drivers of health disparities, especially in the elderly. T2DM is a chronic disease that is highly prevalent in 
the elderly, associated with significant racial/ethnic disparities, and impacted by social determinants of health 
(Walker 2016, Williams 2016, Walker 2015). Elderly individuals with diabetes have high multimorbidity, 
complex treatment regimens, impaired functional status and are often impacted by psychosocial  determinants 
of health such as food insecurity, housing insecurity, competing needs, stress/coping, cognitive dysfunction, 
limited social and financial resources, and social isolation (Young-Hyman 2016, Tomaka 2006, Billimek 2012, 
Nicklett 2013). These factors create challenges for lifestyle and medical management (Kirkman 2012).  
Behavioral activation is a cognitive behavior therapy, originally developed to address depression, that 
has shown promise in individuals with chronic medical conditions, including T2DM (Lejuez 2001, Lejuez 2011, 
Schneider 2016, Kaltman 2016, Weiss 2015). The focus on identifying and increasing the incorporation of 
activities into a patient’s daily schedule, lends behavioral activation to incorporation into treatment for patients 
with diabetes (Lejuez 2011). In fact, several pilot studies suggest behavioral activation can be effective in 
improving self-care behaviors and adherence to treatment recommendations for patients with diabetes 
(Schneider 2016, Kaltman 2016, Weiss 2015). However, Latina/os and African Americans experience a 
number of barriers (e.g., language, culture, stigma) and, as a result, consistently underutilize and prematurely 
terminate behavioral treatments compared to other cultural groups (Alegria 2010). Several meta-analyses have 
concluded that culturally-adapted treatments improve outcomes in comparison to un-adapted treatments 
among racial/ethnic minority groups (Smith 2011; Griner 2006). This suggests that there is opportunity to 
address health care disparities by culturally adapting behavioral interventions and making them more relevant 
to better address the behavioral health needs of these traditionally underserved populations.  
The aims of this randomized efficacy trial are: 
Aim: To test the efficacy of Home DM-BAT on glycemic control (hemoglobin A1c). 
Hypothesis: Low income, minority seniors with poorly controlled T2DM randomized to Home DM-BAT 
will have significantly greater improvements glycemic control (hemoglobin A1c) at 12 months of follow-up 
compared to the control group (in-home, supportive therapy - ST). 
Scientific Premise. Persistent disparities based on race/ethnicity and socioeconomic status in healthcare are 
well documented in the United States (IOM 2003, AHRQ 2015, Williams 2016). Social determinants of health 
are key drivers of health disparities, especially in the elderly. T2DM is a chronic disease that is highly prevalent 
in the elderly, associated with significant racial/ethnic disparities, and impacted by social determinants of health 
(Walker 2016, Williams 2016, Walker 2015). Elderly individuals with diabetes have high multimorbidity, 
complex treatment regimens, impaired functional status and are often impacted by psychosocial  determinants 
of health such as food insecurity, housing insecurity, competing needs, stress/coping, cognitive dysfunction, 
limited social and financial resources, and social isolation (Young-Hyman 2016, Tomaka 2006, Billimek 2012, 
Nicklett 2013). These factors create challenges for lifestyle and medical management (Kirkman 2012). 
Behavioral activation is a cognitive behavior therapy, originally developed to address depression, that has 
shown promise in individuals with chronic medical conditions, including T2DM (Lejuez 2001, Lejuez 2011, 
Schneider 2016, Kaltman 2016, Weiss 2015). Preliminary data from our group has demonstrated that 8 
sessions of culturally-modified, manualized, diabetes-modified, behavioral activation treatment that 
incorporates: 1) diabetes education, 2) addresses social determinants of health (e.g. food insecurity, housing 
insecurity, competing needs, stress/coping etc.), and 3) brief behavioral activation treatment achieved 
maintenance of glycemic control in older adults with T2DM. The proposed study will test new strategies for 
improving clinical outcomes for T2DM in minority elders by addressing both diabetes-specific factors and social 
determinants of health that impede optimal health in this population.  
Study Overview. This study will evaluate the efficacy of 8 sessions of in-home, telephone-delivered, culturally-
modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) delivered by trained 
diabetes nurse educators among low income, ethnic minority seniors (age ≥65 years of age) with poorly 

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controlled T2DM (HbA1c ≥8%), living in independent, subsidized, assisted senior housing facility or community 
dwelling elderly adults in the greater Milwaukee area and surrounding counties that have high African 
American/Hispanic populations. 200 low income, minority seniors will be randomized to Home DM-BAT 
(n=100) or the control condition (in-home, telephone-delivered supportive therapy -ST) (n=100) to control for 
attention. The intervention includes 8 weekly intervention sessions and 10 monthly booster sessions delivered 
via telephone. The individual sessions will last 30-45 minutes based on our prior preliminary studies. Study 
assessments will be at baseline, 3-, 6-, 9-, and 12-months of follow-up. Primary analyses will be conducted at 
12 months post-randomization.  
 
Study Population & Recruitment Plan 
Study Sites: The study sites for this study are residents of independent, subsidized, assisted senior housing 
facility or community dwelling elderly adults in the greater Milwaukee area and surrounding counties that have 
high African American/Hispanic populations.  
Recruitment Strategy: After obtaining approval from the Institutional Review Board, we will use multiple 
complementary approaches to identify eligible study subjects. The first method will consist of referral from 
administrators and staff members at the senior housing sites (see attached letters of support). The PI will 
meet with the appropriate administrators at the senior sites to receive approval to conduct the study at the 
identified sites and recruit residents to participate in the study. In addition, the PI will provide a study overview, 
explain the study procedures, and discuss logistics for conducting the study at the senior housing sites. The 
administrators and staff members will be asked to recommend residents who they deem appropriate (i.e., 
poorly controlled glucose, motivated, history of participating in prior studies, and/or interest in research) to 
participate in the study. After receiving permission to approach those individuals, they will be invited to the 
baseline visit to assess eligibility. The second method will include the posting and distribution of recruitment 
flyers throughout the senior housing sites and to residents, respectively. The third approach will be to advertise 
the study via multiple strategies to community dwelling elderly adults that are eligible for the study within the 
community. The fourth approach will consist of referrals from residents and community dwelling elderly adults 
in response to recruitment flyers and advertisements. Those interested in participating in the study will be 
contacted for screening. If eligibility criteria are met, the baseline/enrollment visit will be scheduled. In addition, 
after obtaining IRB approval for a partial waiver of HIPAA, the final approach will be to query clinic billing 
records. Search criteria will include patient demographics and ICD coded diagnosis to allow identification of 
subjects with ICD-10 codes consistent with a diagnosis of T2DM.  Identified eligible participants will be sent 
recruitment and informational letters. We have successfully used these approaches in our past and current 
research. Other approaches will include local advertisement on relevant media, billboard, and organizational 
sites. The final method used will include the enrollment of study champions across the senior community who 
will actively identify and refer potential study subjects to the study. The study champions will be community 
members recruited into this study to serve as champions for a duration of 12 months, eligibility criteria 
discussed further below. As HOME DM-BAT is a community-based study, the use of study champions will 
serve as a complementary method that will be drawn in part from prior methodology in community based 
participatory research (Minkler and Wallerstein, 2008). Specifically, as community members, the champions 
will have an understanding of the barriers and facilitators that many seniors with diabetes experience and will 
therefore be able to facilitate recruitment into the study as a champion. As the champions will be participating 
in the research process through recruitment and retention, all champions will be compensated for their time, 
see details below. Champions will undergo a formal informed consent process and will complete a screening 
survey as well as an exit survey at the completion of the study. Once champions are enrolled, they will undergo 
three sequential training sessions to prepare them for their champion role. These training sessions will include: 
1) overview of the study goals and objectives, 2) ethical considerations for research, and 3) procedures for 
recruitment into a research study. The study champions will have ongoing communication with members of the 
study team during the recruitment process to provide a forum for updates. In addition, champions will have 
their HbA1c measured as a part of the enrollment procedure. While the HbA1c level will not serve as an 
exclusionary factor, it will provide information on diabetes management for study champions, which prior 
evidence has shown this to be an important factor when enrolling participants as facilitators for research 
procedures (Long, 2012).  
Participant Payment: Participants will receive $10 for completion of screening, $15 for completion of baseline, 
and $25 for completion of 3, 6, 9, and 12-month assessments for a total payment of $125.  

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Patient Eligibility Criteria: The study inclusion and exclusion criteria are as follows 
Inclusion Criteria: 1) Age ≥65 years of age; 2) Self-identified as Black/African American or Hispanic; 3) Clinical 
diagnosis of T2DM verified by an HbA1c ≥8% at the screening assessment; 4) Able to communicate in English 
or Spanish; and 5) Resident of independent, subsidized, assisted senior housing facility or community dwelling 
elderly adults in the greater Milwaukee area and surrounding counties that have high African 
American/Hispanic populations. 
Exclusion Criteria: 1) Mental confusion at screening assessment suggesting significant dementia; 2) 
Participation in other diabetes research; 3) Alcohol or drug abuse/dependency at screening assessment; 4) 
Active psychosis or acute mental disorder at screening assessment; and 5) Life expectancy <12 months at 
screening assessment based on medical history and comorbidity screen used in prior studies. 
 
 
Description of the Home DM-BAT Intervention: A trained nurse educator will deliver the manualized Home 
DM-BAT intervention via telephone. Subjects will receive 8–weekly sessions of behavioral activation and 
monthly booster sessions from months 3-12. Home DM-BAT is extremely suitable to standard diabetes 
management approaches because it targets important diabetes management behaviors (medication taking, 
physical activity, health eating, and self-monitoring of glucose and BP). Moreover, Home DM-BAT specifically 
attempts to incorporate contingencies of environmental reinforcement for positive health behaviors, with a 
focus on medication adherence and other diabetes specific healthy behaviors including physical activity, 
healthy eating, abstinence from smoking, and involvement in pleasurable activities that the patient chooses, 
such as spending time with friends, spirituality, or volunteer work. These supplemental activities are directed at 
improving overall emotional well-being. All intervention sessions will be delivered by telephone at times that do 
not interfere with previously scheduled activities. Each individual session will last 45 minutes and will include 
15 minutes for a previously tested diabetes education/skills training intervention based on ADA guidelines, 30 
minutes for diabetes-tailored behavioral activation and to address social determinant of health issues.     
 
Control Group (GHE+ST): Patients randomized to the control group will receive in-home, telephone-delivered 
8–weekly sessions of combined general health education (GHE) and supportive therapy (ST) and monthly 
booster sessions from months 3-12. Given that this is an effectiveness trial, the control group was designed to 
match the intervention group for both content and attention. The GHE component matches the diabetes 
education component of Home DM-BAT and ST component matches the behavioral activation component of 
Home DM-BAT. In addition, delivering GHE/ST to the control group will reduce attrition, maintain blinding, and 
maintain community trust. The control group will not receive diabetes education, address social determinants 
of health, or behavioral activation. We have used the GHE+ST modules successfully in prior RCTs. 
 
Data Collection Strategy 
Personnel: Nurse diabetes educators (NDE) will deliver the interventions; study staff will conduct screening, 
consent, enrollment procedures, and questionnaire administration. Data collection will occur at locations 
convenient to the patient including the senior housing facilities, participants homes, MCW research 
facilities, or appropriate community locations. The RAs will travel to the sites to administer study 
questionnaires, while the study nurses and/or phlebotomists will perform blood draws. Blood 
specimen will be hand carried using appropriate safety containers by nurses and/or phlebotomists at 
the end of each visit to MCW lab for analysis in compliance with MCW standard operating procedures.    
 
 
Data Management: The MCW REDCap system will be used for data management. REDCap (Research 
Electronic Data Capture) is a secure, web-based application designed exclusively to support data capture for 
research studies initiated at Vanderbilt University (http://project-redcap.org/). REDCap provides: 1) an intuitive 
interface for data entry (with data validation); 2) audit trails for tracking data manipulation and export 
procedures; 3) automated export procedures for seamless data downloads to common statistical packages 
(SPSS, SAS, Stata, R); 4) procedures for importing data from external sources; and 5) advanced features, 
such as branching logic and calculated fields. We have used REDCap successfully for multiple clinical trials. 
 

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Patient Randomization: A permuted block randomization method will be used to assign subjects to one of the 
two intervention groups: (a) Home DM-BAT intervention; and (b) Control (GHE/ST).  Block size will be varied to 
minimize the likelihood that the blind will be broken. The randomization will be stratified by baseline HbA1c 
levels (8-10% vs. >10%). 
 
Sample Size and Power. For comparing the difference in outcome means for Home DM-BAT versus GHE/ST 
in an individually-randomized design, with 80 participants per group, there will be 85% power to detect a 
standardized effect size ranging from 0.34 to 0.39 for the primary endpoint at 12 months [assuming level of 
significance alpha=0.05 (two-tailed); To account for missing information in the ITT sample and the dilution 
effect of ITT analyses, we increase the sample size by 20% to achieve a final ITT sample size of 100 
participants randomized 1:1 to each treatment group (total N=200 randomized participants).  
 
PROTECTION OF HUMAN SUBJECTS  
1.  RISKS TO THE SUBJECTS  
 
Potential Risks  
Potential risks to the participants include possible violation of each participant’s privacy, discomfort with 
questions on the research questionnaire, discomfort and bleeding from blood draws, discomfort with BP 
measurement, and psychological distress. Details on how these risks will be minimized are discussed under 
adequacy of protection against risks below. 
Confidentiality:  This will be maintained by keeping participant folders in locked file cabinets in the 
investigator's locked office.  Only participants’ unique identification numbers will be recorded in folders and on 
data forms.  The database will remain on the MCW computer system using unique ID numbers, rather than 
names, and will be password-protected.   
2.  ADEQUACY OF PROTECTION AGAINST RISKS  
b. Protection against Risk 
1. Participants will be protected against potential risks as follows: 
a. Psychological Distress: Because we will be administering a questionnaire that measures the presence of 
depression, we will take several steps to ensure the safety of research participants. RAs will be trained by the 
PI to identify patients who meet criteria for depression on the PHQ-9. Participants who screen positive for 
depression will be notified during the visit and verbally instructed to seek care from their Primary Care Provider 
(PCP). They will also be given the Suicide Prevention National Hotline: 1-800-SUICIDE (784-2433), and told to 
call if they experience acute worsening of symptoms before they can be seen by their PCP. 
b. Venipuncture (blood drawing): To reduce the risks of discomfort and bruising, venipuncture will be 
performed by the nurse educator and discarded per routine lab policy/procedures at an appropriate laboratory. 
To reduce the risk of fainting, blood will be drawn while participants are in a seated position. The amount of 
blood that will be drawn, approximately 10cc, is not considered to pose a health risk for most adults. 
c. Blood Pressure Measurement: To lessen any associated risks, BP measurements will be performed by 
the study nurses utilizing a standardized protocol. Participants with elevated BP will be advised to contact their 
PCP. Those with potentially life-threatening BP readings will be sent to a local emergency room for treatment. 
d. Administration of Research Questionnaires: Some participants might feel uncomfortable or be offended 
by detailed questions about emotional or physical health status and impairment, and healthcare utilization. All 
participants will be informed during the consent process that they may terminate participation at any point. Our 
past research suggests that data collection using these measures can be conducted without undue 
psychological distress or exacerbation of symptoms among study participants. 
e. Unknown risks: Subject participation in research may have other unknown risks. The researchers will 
advise participants if they learn of emerging information that might alter participants’ decisions to participate. 
2. Participants requiring medical or other professional intervention for study-related events will be provided with 
appropriate and timely medical guidance by the designated medical monitor. If adverse events occur during the 
conduct of this study, they will be reported to the MCW IRB in accordance with the appropriate guidelines. The 
results of participants’ clinical assessments will be available within a few weeks of their study visit. The 

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designated medical monitor will review and inform participants of these results by phone and, at their request, 
also advise their personal PCP of the results. 
3. To protect against the potential risk of loss of confidentiality and/or breach of privacy, data will be compiled 
using codes in lieu of personal identifiers. Access to study data will be limited to research personnel. 
Development of and security oversight for the electronic database for this study will be performed by the PI, 
study data coordinator/data entry clerk, and study statistician. Paper documents pertaining to this study will be 
stored in locked file cabinets, and electronic data will be entered into secure, password-protected databases 
developed for this study by the data coordinator/data entry clerk. The PI will perform periodic review of the data 
entry process to ensure accuracy of recording. When study results are published or presented, only aggregate 
reports of the results will be used and participants’ identities will not be revealed. A file of names, contact 
addresses, telephone numbers, and other research identification numbers will be stored separately on paper 
and on computer, for purposes of audit by the sponsor (NIH/NIMHD) and MCW IRB, if necessary. 
 
3.  POTENTIAL BENEFITS OF THE PROPOSED RESEARCH TO THE SUBJECTS AND OTHERS  
The intervention is expected to benefit patients, by 1) increasing their knowledge of diabetes, 2) 
activating and empowering them to better care for their diabetes, 3) improving blood glucose, blood pressure, 
and blood lipid control, and 4) reducing their risk developing complications of diabetes. Patients in the 
supportive therapy group will benefit by increasing their general health knowledge. 
  
4.  IMPORTANCE OF THE KNOWLEDGE TO BE GAINED  
Key drivers of health disparities and key areas for interventions are the social determinants of health, or 
the economic and social conditions that influence health status. Considerable evidence now exists linking 
social determinants to a range of health outcomes, especially in chronic diseases such as type 2 diabetes, 
where a clear majority of minorities and the elderly are affected at alarming rates. Given the need to address 
multiple medical concerns during brief and often short, clinical visits, psychosocial factors are often not 
discussed extensively, resulting in the need for alternative approaches for addressing psychological well-being 
in elderly patients. Behavioral activation is a cognitive behavior therapy recommended as a cost-effective 
alternative to more intensive psychological therapies when treating patients with chronic and comorbid 
conditions. Evidence suggests behavioral activation can be effective in improving self-care behaviors and 
adherence to treatment recommendations for patients with diabetes. Therefore, this study has been designed 
particularly for elderly patients with diabetes. If successful, the findings of this study will demonstrate an 
alternative approach for addressing psychological stressors, lessening the impact of social determinants of 
health on outcomes, and improving general well-being by increasing social activities and decreasing social 
isolation among seniors with poorly controlled type 2 diabetes.  
 
DATA AND SAFETY MONITORING PLAN  
 
Quality assurance and data integrity 
The PI will be responsible for monitoring quality assurance and data integrity. Meetings with the PI, co-
investigators, and study staff will take place weekly throughout the study. At each meeting the team will 
discuss recruitment and accrual, protocol questions, retention, and data entry concerns. Enrollment numbers 
will be maintained and reported to the study team on an ongoing basis, along with information on reasons for 
exclusion, dates of completion of the study, and demographic summaries. All research staff will have training in 
human subjects research, including data integrity and protection of confidentiality, and will follow standard 
procedures such as storage of hard copies of assessments and other data in locked file cabinets and 
separation of consent forms and identified master lists in separate locations. Study files will be maintained on 
an MCW server that provides nightly backup procedures and HIPPA compliant firewalls.  
 
Assessments will be administered by trained personnel using validated surveys on standardized collection 
forms. Training of study staff on administration of self-report measures and standard operating procedures will 
be done by the PI and co-investigators. Completed forms will be checked manually for missed entries, invalid 
responses, and corrected as necessary before the participant leaves. Accuracy of data entry will be ensured by 
RedCAP database field controls, and quarterly audits on data records to ensure accurate and complete data 

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collection. 
 
Safety monitoring 
The safety monitoring plan will include an internal Data Safety Monitoring Committee (DSMC) and the 
institutional IRB.  The purpose of the DSMC and IRB are to ensure the safety of participants and the validity 
and integrity of the data. Summaries of adverse events reports or patient safety concerns raised by the DSMC 
will be made to the IRB in the yearly progress unless the nature of a particular event is such that it bears 
reporting to IRB immediately.  
 
DSMC: The internal DSMC will consist of the PI, biostatistician, co-investigators on the proposal, and the 
designated medical monitor. The functions of the DSMC will include: 1) provide scientific oversight; 2) review 
all adverse effects or complications related to the study; 3) monitor accrual; 4) review summary reports relating 
to compliance with protocol requirements; and 5) provide advice on resource allocation. The DSMC will meet 
quarterly and as necessary by telephone. The recommendations of the DSMC will be reviewed and the PI will 
take appropriate corrective actions as needed. 
   
Institutional IRB: The IRB will review and approve the funded protocol, review patient consent forms, ensure 
protection of patient privacy and safety, and monitor the study on an ongoing basis. Adverse events will be 
reported to the IRB as they occur. Annual reports to the IRB will indicate accrual rate, adverse events, new 
findings that may influence continuation of the study, and reports of the DSMC.