Pilot trial results of D-HOMES: a behavioral-activation based intervention for diabetes medication adherence and psychological wellness among people who have been homeless

Introduction: People living with type 2 diabetes who experience homelessness face a myriad of barriers to engaging in diabetes self-care behaviors that lead to premature complications and death. This is exacerbated by high rates of comorbid mental illness, substance use disorder, and other physical health problems. Despite strong evidence to support lay health coach and behavioral activation, little research has effectively engaged people living with type 2 diabetes who had experienced homelessness (DH). Methods: We used community engaged research and incremental behavioral treatment development to design the Diabetes HOmeless MEdication Support (D-HOMES) program, a one-on-one, 3 month, coaching intervention to improve medication adherence and psychological wellness for DH. We present results of our pilot randomized trial (with baseline, 3 mo., 6 mo. assessments) comparing D-HOMES to enhanced usual care (EUC; brief diabetes education session and routine care; NCT05258630). Participants were English-speaking adults with type 2 diabetes, current/recent (<24 mo.) homelessness, and an HbA1c‗7.5%. We focused on feasibility (recruitment, retention, engagement) and acceptability (Client Satisfaction Questionnaire, CSQ-8). Our primary clinical outcome was glycemic control (HbA1c) and primary behavioral outcome was medication adherence. Secondary outcomes included psychological wellness and diabetes self-care. Results: Thirty-six eligible participants enrolled, 18 in each arm. Most participants identified as Black males, had high rates of co-morbidities, and lived in subsidized housing. We retained 100% of participants at 3-months, and 94% at 6-months. Participants reported high satisfaction (mean CSQ-8 scores=28.64 [SD 3.94] of 32). HbA1c reduced to clinically significant levels in both groups, but we found no between group differences. Mean blood pressure improved more in D-HOMES than EUC between baseline and 6 mo. with between group mean differences of systolic -19.5 mmHg (p=0.030) and diastolic blood pressure -11.1 mmHg (p=0.049). We found no significant between group differences in other secondary outcomes. Conclusion: We effectively recruited and retained DH over 6 months. Data support that the D-HOMES intervention was acceptable and feasible. We observe preliminary blood pressure improvement favoring D-HOMES that were statistically and clinically significant. D-HOMES warrants testing in a fully powered trial which could inform future high quality behavioral trials to promote health equity. Clinical trial registration: https://clinicaltrials.gov/study/NCT05258630?term=D-HOMES&rank=1, identifier NCT05258630.