Comparative Effectiveness of Adding Family Supporter Training to a CHW-Led Intervention to Improve Behavioral Management of Multiple Risk Factors for Diabetes Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 444
- 试验地点
- 4
- 主要终点
- Change From Baseline in Patient Glycemic Control at 6 Months
研究概览
简要总结
The objective of this study is to compare the effectiveness of a novel program-Family Support for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management education and support (I-DSMES).
详细描述
FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management for adults with diabetes (AWDs):
- coach family supporters in regular discussions about AWDs' diabetes progress and goals that uses empathetic and autonomy-supportive communication,
- coach family supporters in practical roles that support diabetes-specific tasks tailored to AWDs' personal goals,
- leverage family support in the setting of other types of social support for AWDs (support from other AWDs and their family members and Community Health Workers (CHWs))
FAM-ACT will be developed and implemented in culturally-concordant ways, in partnership with the community participating in the program.
Adults with type 2 diabetes and either poor glycemic or blood pressure control will be randomized together with a Support Person (a chosen adult family member or friend) to receive either FAM-ACT or more traditional CHW-led patient-focused I-DSMES over 6 months.
See our published protocol (Deverts et al 2022; full citation in references section) for additional details on the protocol including any changes made after the study started.
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)
盲法说明
Outcomes Assessor will be unaware of the arm assignment of the participant when assessing main outcomes.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of Type 2 diabetes
- •Most recent HbA1c done in the 3 months prior to screening phone call >= 7.5%
- •Plan to use recruiting site for health care over the next 12 months after enrollment
- •Must be able to identify a family member or friend who is willing to be involved in their health care
排除标准
- •Diagnosis (active or prior) of Alzheimer's disease or dementia
- •Preferred language is not English or Spanish
- •Diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder in CHASS EMR Problem list as of screening call date
- •Diagnosis of gestational diabetes without any other diabetes diagnoses
- •Diagnosed with diabetes at age < 21 years
- •Pregnant or planning to become pregnant in the next 12 months
- •Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
- •Have a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen)
- •Support Person Inclusion Criteria:
- •Able to attend intervention sessions in person or remotely via online video-conferencing
- •At least 21 years old
- •Support Person Exclusion Criteria:
- •Does not speak English or Spanish
- •Receives pay for caring for the patient
- •Has self-reported serious mental illness (schizophrenia)
- •Has a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen)
- •Has significant cognitive impairment (Alzheimer's disease or dementia)
- •Lives in a nursing home or long-term care facility
- •Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
结局指标
主要结局
Change From Baseline in Patient Glycemic Control at 6 Months
时间窗: Baseline vs. 6 months
Hemoglobin A1c (HbA1c, percent) was measured via finger stick performed by a study research assistant, by a clinician as a part of the patients' regular care, or by patients via home test kit. For analysis, HbA1c first was examined graphically to understand how it changed over time. Main analyses then were conducted using linear mixed-effects models, with 12-month HbA1c values included in the models to increase the power to estimate changes over the initial 6 months. Adjusted outcome and effect estimates at 6 months were derived from linear mixed models using linear contrasts. The model was fitted using all available time points (baseline, 6 months, and 12 months) from all 222 enrollees to make efficient use of the data. Including all time points allows the model to account for individual trajectories over time, thus increasing power to detect treatment effects and reducing bias that could arise from analyzing the 6-month time point in isolation.
次要结局
- Change From Baseline in Patient Glycemic Control at 12 Months(Baseline vs. 12 months)
- Change From Baseline in Patient Systolic Blood Pressure at 6 Months(Baseline vs. 6 months)
- Change From Baseline in Patient Systolic Blood Pressure at 12 Months(Baseline vs. 12 months)
- Change From Baseline in Patient Diabetes Distress at 6 Months(Baseline vs. 6 months)
- Change From Baseline in Patient Diabetes Distress at 12 Months(Baseline vs. 12 months)
- Change From Baseline Patient Diabetes Self-care Behaviors at 6 Months: Healthy Eating(Baseline vs. 6 months)
- Change in Diabetes Self-care Behaviors in Patient: Physical Activity(Baseline vs. 6 months)
- Change in Diabetes Self-care Behaviors in Patient: Medication Adherence(Baseline vs. 6 months)
- Change in Self-efficacy of Patient(Baseline vs. 6 months)
- Change in Patient Activation in Patient(Baseline vs. 6 months)
- Patient Perceived Overall Satisfaction With SP Support for Diabetes(Baseline vs. 6 months)
- Patient Perception of SP Support: Supportive and Non-supportive Behaviors(Baseline vs. 6 months)
- Impact of COVID on Ability to Manage Diabetes(Cross-sectional at 6 months)
- Change in Diabetes Distress in Support Person(Baseline vs. 6 months)
- Change in Self-efficacy of Support Person(Baseline vs. 6 months)
研究者
Ann-Marie Rosland
Associate Professor
University of Pittsburgh