Table 1.
CALMS-D RCT | CALMS-D sub-study 1 | CASMS-D sub-study 2 |
DREAM | |
---|---|---|---|---|
Study design and primary outcome | 2-arm RCT: diabetes education vs diabetes education + stress management. Outcome: HbA1c and depressive symptoms | 7-day micro-longitudinal observation of relationships between stressors, mood, health behaviors, and glucose | Single session of observation of autonomic responses to physical challenges | 3-arm RCT: social services vs lifestyle vs lifestyle + pharmacist. Outcome: HbA1c, depressive symptoms, insulin resistance |
Methods for evaluating LHR | Independent observer fidelity checklists | Independent observer fidelity checklists | Independent observer fidelity checklists | Rates of missing/unusable data |
In-depth interviews | In-depth interviews | In-depth interviews | ||
# CBOs employing LHR | 1 | 1 | 1 | 2 |
Participants | N = 121 low-income, Latino, urban, type 2 diabetes, reside in Hartford, CT. Spanish speaking | N = 50 from parent study | N = 35 from parent study | N = 188 low-income, low-literacy, Cambodian, elevated depressive symptoms, high risk for diabetes, reside in CT, MA, or RI. Khmer speaking |
LHR | 3 Latina. Bilingual Spanish/English speaking and reading. Educational attainment high school graduate to some college courses | Same as for parent study | Same as for parent study | 8 Cambodian, born in Cambodia. Bilingual Khmer/English speaking, a few were Khmer reading. Educational attainment high school to bachelor’s degree |
Data collection location | Data were collected in the home or at the CBO, per participant request; most were completed in the home | Data were collected in the home | Data were collected in the home | Data were collected in the home, at the CBO, or at a community venue (e.g., church, clinic) per participant request; most were completed in the home |
Data collected by LHR | 24-hour urine sample | Interactive voice response system | Serial blood pressures | Sleep actigraphyPhysical activity actigraphyHair samplesTrauma surveys |
Holter monitor | Continuous glucose monitor |
CALMS-D = community health workers assisting latinos manage stress and diabetes; CBO = community-based organization; CT, MA, RI = Connecticut, Massachusetts, Rhode Island; DREAM = diabetes risk reduction through eat, walk, sleep, and medication therapy management; LHR = lay health research personnel; RCT = randomized clinical trial.