intervention to improve diabetes outcomes in older african american women with multi-caregiving burden

Conditions: Type 2 Diabetes

Summary: this is a two arm, pilot randomized control trial (rct) in which 60 african american women (aaw), 40-64 years of age, with hba1c ≥8% and multi-caregiving responsibilities will be recruited from communities in milwaukee, wisconsin and randomized to either: 1) an individual-based, social support, health educator-facilitated intervention to address multi-caregiving responsibilities (n=30), or 2) individual-based, health educator-facilitated diabetes education and skills training and general health education (n=30). all sessions will be delivered via telephone (i.e., landline, mobile device, smart device, etc.) by a health educator (i.e., nurse, social worker, master's trained health educator) and is comprised of 12 weekly sessions and 3 booster sessions. each session will last up to 60min. all study assessments will be administered by a program assistant at baseline, 3-months, and 6-months.

the investigators propose to test the feasibility and preliminary efficacy of this multi-caregiving intervention on improving outcomes among aaw, ages 40-64 years with type 2 diabetes (t2dm) and multi-caregiving responsibilities using a pilot randomized design compared to diabetes enhanced usual care. the goals of the study will be assessed under the following specific aims: aim 1: to determine the feasibility of the multi-caregiving intervention as measured by recruitment, session attendance, retention, and treatment adherence in aaw with t2dm aim 2: to test the preliminary efficacy of the multi-caregiving intervention on glycemic and blood pressure control in aaw with t2dm compared to individual-delivered, health-educator led diabetes enhanced usual care at 6 months hypothesis 1: aaw who receive the multi-caregiving intervention will have significant reductions in hemoglobin a1c at 6 months compared to aaw who receive diabetes enhanced usual care hypothesis 2: aaw who receive the multi-caregiving intervention will have significant reductions in blood pressure at 6 months compared to aaw who receive diabetes enhanced usual care aim 3: to test the preliminary efficacy of the multi-caregiving intervention on self-care behaviors and quality of life in aaw with t2dm compared to individual-delivered, health educator led diabetes enhanced usual care at 6 months hypothesis 1: aaw who receive the multi-caregiving intervention will have significant improvements in self-care behaviors (diet, physical activity, medication adherence, and blood glucose monitoring) at 6 months compared to aaw who receive diabetes enhanced usual care hypothesis 2: aaw who receive the multi-caregiving intervention will have significant improvements in quality of life (sf-12 scores) at 6 months compared to aaw who receive diabetes enhanced usual care in the final 6-month assessment, study participants will be asked to participate in 30 to 40-minute, semi-structured interviews by telephone. findings will help refine the intervention and emphasize elements that enhance participant uptake and motivation for sustained behavior change for the future r01.

Eligibility criteria:
inclusion criteria: * age 40-64 years * self-identifies as female * self-identifies as african american or non-hispanic black * self-reports multi-caregiving responsibilities * clinical diagnosis of t2dm based on hba1c≥8% at the screening/baseline assessment * able to communicate in english * access to a telephone (i.e., landline, mobile device, smart device, etc.) exclusion criteria: * mental confusion at screening/baseline assessment suggesting significant dementia, active psychosis, or acute mental disorder * participation in other diabetes trials * life expectancy \<6 months based on screening questionnaire