A randomized trial to decrease risk for diabetes among Cambodian Americans with depression: Intervention development, baseline characteristics and process outcomes

Abstract

Background: Depression and antidepressant medications are associated with increased risk for type 2 diabetes. It is not known if diabetes can be prevented in the setting of depression. Cambodian Americans have high rates of both depression and diabetes. This paper reports intervention development, experimental design, baseline characteristics, and process outcomes of diabetes prevention interventions for Cambodian Americans with depression, “Diabetes Risk Reduction through Eat, Walk, Sleep and Medication Therapy Management” (DREAM). Methods: Participants were aged 35–75, Khmer speaking, at high risk for developing diabetes, and met criteria for likely depression by either a) antidepressant medication and/or b) elevated depressive symptoms at two time-points during a study eligibility period. Treatment arms were: 1) community health educator (CHE) delivered lifestyle intervention called Eat, Walk, Sleep (EWS), 2) EWS plus pharmacist/CHE-delivered medication therapy management (EWS + MTM), and, 3) social services (SS; control). Results: 188 participants were randomized. Treatment fidelity was high (98% checklist adherence) and on a scale from 0 to 3, participants reported high EWS treatment satisfaction (M = 2.9, SD = 0.2), group cohesion (M = 2.9, SD = 0.3), and therapeutic alliance to CHEs (M = 2.9, SD = 0.2) and to pharmacists (2.9, SD = 0.3). Attendance was challenging but highly successful; in EWS, 99% attended ≥ one session and 86% completed ≥ 24 sessions, M = 27.3 (SD = 3.7) sessions. Of those randomized to EWS + MTM, 98% attended at least one MTM session and 77%) completed ≥ 4 sessions. Retention was high, 95% at 12-month and 96% at 15-month assessments. Conclusions: The interventions were successfully implemented. Lessons learned and suggestions for future trials are offered. ClinicalTrials.gov identifier: NCT02502929

Risk factors for drug therapy problems among Cambodian Americans with complex needs: a cross-sectional, observational study

“…STROBE guidelines (von Elm et al, 2007 ) were followed for reporting. Secondary data analysis was conducted on baseline assessments from a diabetes prevention trial for Cambodian Americans with depression, the Diabetes Risk Reduction through Eat, Walk, Sleep and Medication Therapy Management (DREAM) trial (Wagner et al, 2021 ), clinicaltrials.gov identifier NCT02502929. Previously published articles provide details of the methods and a CONSORT diagram (Polomoff et al, 2021 ; Wagner et al, 2021 ).…”

“…Secondary data analysis was conducted on baseline assessments from a diabetes prevention trial for Cambodian Americans with depression, the Diabetes Risk Reduction through Eat, Walk, Sleep and Medication Therapy Management (DREAM) trial (Wagner et al, 2021 ), clinicaltrials.gov identifier NCT02502929. Previously published articles provide details of the methods and a CONSORT diagram (Polomoff et al, 2021 ; Wagner et al, 2021 ). The data reported here are from baseline assessments only and solely for those participants who were randomized to receive MTM intervention and therefore completed a DTP review.…”

“…CHWs met with participants to complete a medication review form. Their training to decrease bias during survey administration and MTM has been previously described (Polomoff et al, 2021 ; Wagner et al, 2021 ). Training the CHWs included shadowing expert pharmacists complete the medication review form, sessions with our pharmacist investigator and the bilingual study coordinator totaling 4 h, and role play with illustrative case examples.…”

Self-reported pain among Cambodian Americans with depression: patient-provider communication as an overlooked social determinant

“…Secondary descriptive data analysis was conducted on baseline assessments from a diabetes prevention trial for Cambodian Americans with depression, clinicaltrials.gov identifier NCT02502929. Details of the methods have been reported previously [9]. Baseline data were collected from March 2016 to March 2019 on a rolling basis as enrollment in the trial continued.…”

“…All participants with baseline data were included in these analyses. The n = 186 resulted from a power analysis of the primary outcome of the trial (depression and HbA1c) [9]. Inclusion criteria were: (1) 7) take meals by mouth; and (8) elevated risk for diabetes per the American Diabetes Association Risk Test.…”