Community-Based Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Change in HbA1c% From Baseline to 6 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •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
研究组 & 干预措施
Multi-Caregiving Intervention
The multi-caregiving intervention consists of individual-based, social support, and health-educator facilitation and includes: a. Storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); Coping strategies (15minutes); and Structured Diabetes Education and Skills Training (15 minutes). The final 5min will be used for debriefing/reviewing goals.
干预措施: Multi-Caregiving Intervention (Behavioral)
Diabetes Enhanced Usual Care Intervention
This is composed of individual-based, health educator-facilitated diabetes education and skills training and general health education and will receive structured diabetes education and skills training as described above (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes).
干预措施: Diabetes Enhanced Usual Care Intervention (Behavioral)
结局指标
主要结局
Mean Change in HbA1c% From Baseline to 6 Months
时间窗: Baseline, 6-months
Trained personnel collected 100cc of blood via venipuncture to measure hemoglobin A1c (HbA1c). All collections were performed in the community at a location convenient for the study participant. At the screening visit, the HbA1c had to be 8% or greater to be eligible for participation.
次要结局
- Change in Physical Activity From Baseline to 6 Months(Screening/Baseline, 3-months, 6-months)
- Change in Blood Pressure Control From Baseline to 6 Months(Screening/Baseline, 3-months, 6-months)
- Change in Blood Glucose Monitoring From Baseline to 6 Months(Screening/Baseline, 3-months, 6-months)
- Change in Medication Adherence From Baseline to 6 Months(Screening/Baseline, 3-months, 6-months)
- Change in Health Related Quality of Life From Baseline to 6 Months(Screening/Baseline, 3-months, 6-months)
研究者
Joni Williams
Associate Professor
Medical College of Wisconsin