A Family Dyad-focused Diabetes Self-Management Intervention for African American Adults With Type 2 Diabetes
概览
- 阶段
- 1 期
- 干预措施
- Family dyad diabetes intervention
- 疾病 / 适应症
- Diabetes Mellitus, Type 2
- 发起方
- Ohio State University
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Change in diabetes control
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
A family dyad-focused diabetes self-management for African American adults with type 2 diabetes is a randomized controlled trial (RCT) that aims to test the feasibility, acceptability, and efficacy of a family-dyad focused intervention on glycemic control (hemoglobin A1c) and health-related quality of life (HRQOL) in African American adults with type 2 diabetes (T2D).
详细描述
Eligible participants and their family members will be randomly assigned to either the intervention and control group. Patient-family-member dyads in the intervention arm will virtually receive 1) 10 session over 12 weeks of family dyad-focused, group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions. All participants will be assessed at baseline, post-intervention and six months after intervention.
研究者
入排标准
入选标准
- •Individual with type 2 diabetes:
- •Self-identification as African American;
- •40 years or older
- •Type 2 diabetes diagnosis for at least six months;
- •A1c \> 7.0% at time of enrollment;
- •Being able to speak and read English;
- •Being able to walk;
- •Having an adult family member/close friend willing to co-participate in the study.
- •Family members:
- •Adults (18 years or older, with or without T2D);
排除标准
- •Individual with T2D and family members:
- •Being pregnant or have an advanced or terminal condition;
- •Being cognitively impaired or unable to provide informed consent;
- •Lack conclusive evidence of T2D for patients with T2D.
研究组 & 干预措施
Intervention
Patient-family member dyads in the family dyad intervention arm will receive 1) 10 sessions (8 weekly and 2 biweekly) over 12 weeks of family-dyad-focused, virtual group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions.
干预措施: Family dyad diabetes intervention
Control
All control participants will receive usual care from their primary healthcare provider. A condensed family dyad diabetes intervention will be delivered to the control participants by the end of the study.
结局指标
主要结局
Change in diabetes control
时间窗: Baseline (T1) to six months after intervention (T3) at month 11
Change in glycosylated hemoglobin A1c will be measured with finger stick blood with a glycosylated hemoglobin A1CNow+ test. Changes in average percent of A1c will be used in the study.
Change in health-related quality of life
时间窗: Baseline (T1) to six months after intervention (T3) at month 11
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) will be used to measure changes in total scores of the global physical and global mental health. Scores range from 0-100 with higher scores indicating better quality of life.
Change in diabetes control
时间窗: Baseline (T1) to immediate post-intervention at month 5 (T2)
Change in glycosylated hemoglobin A1c will be measured with finger stick blood with a glycosylated hemoglobin A1CNow+ test. Changes in average percent of A1c will be used in the study.
Change in health-related quality of life
时间窗: Baseline (T1) to immediate post-intervention at month 5 (T2)
Patient-Reported Outcomes Measurement Information System Global Health (PROMIS 10) will be used to measure changes in total scores of the global physical and global mental health. Scores range from 0-100 with higher scores indicating better quality of life.
次要结局
- Change in blood pressure control(Baseline (T1) to six months after intervention (T3) at month 11)
- Change in blood pressure control(Baseline (T1) to immediate post-intervention at month 5 (T2))