Using Multifamily Groups to Improve Family-Centered Self-Management of Type 2 Diabetes Among Mexican-Americans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Change in Diabetes Self-Management Behaviors (Revised Summary of Diabetes Self-Care Activities)
研究概览
简要总结
The overall objective of this study is to construct an adaptive intervention that integrates family members and patients as partners in care while promoting diabetes self-management for Mexican Americans with Type 2 diabetes. The project incorporates four evidence-based, culturally tailored treatments using a Sequential, Multiple Assignment Randomized Trial to help determine what sequence of intervention strategies work most efficiently and for whom.
详细描述
The project evaluates four culturally adapted, family-based treatments designed to improve health status, self-management behaviors and self-efficacy among Mexican-Americans with Type 2 diabetes using a Sequential, Multiple Assignment Randomized Trial in a public health setting. In the first phase of the study, subjects will be randomly assigned to six 2.5 hour sessions (three months) of either: 1) Tomando Control de su Diabetes (TC), a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by community health workers (promotoras) working with individual patients and families; or 2) TC delivered by health professionals (licensed nurses). Evaluations will be made at baseline, three months, six months and 12 months. After six weeks of treatment (at the midway point of the intervention), subjects will be assessed for improvement in diabetes self-management behaviors (the primary outcome). In the second phase of the study, those subjects who have improved their diabetes self-management behaviors by 50% over baseline will be continued in their assigned treatment for the duration of three months. Those subjects who do not meet this target will be re-randomized to receive either: 1) an augmented version of TC that has a specific focus on engaging family members; or 2) a multifamily group treatment led by nurses specially trained in teaching diabetes self-management skills for an additional three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Raters are blind to treatment condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mexican origin and speaks Spanish fluently
- •age 18 years or older
- •medical chart diagnosis of Type 2 diabetes
- •living with at least one adult family member who is willing to participate.
排除标准
- •diagnosis of Type 1 diabetes
- •participation in another Diabetes Self-management education program within the past 12 months
- •significant cognitive impairment.
研究组 & 干预措施
Tomando Control-Nurse
Tomando Control de su Diabetes-Nurse is a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by licensed nurses working with individual patients and families.
干预措施: Tomando Control-Nurse (Behavioral)
Tomando Control-Promotora
Tomando Control de su Diabetes-Promotora is a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by community health workers (promotoras) working with individual patients and families.
干预措施: Tomando Control-Promotora (Behavioral)
Enhanced Engagement-Nurse
Tomando Control de su Diabetes-Nurse is a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by licensed nurses working with individual patients and families. If subjects do not benefit sufficiently, the subject may be randomized to receive three home visits to facilitate engagement with treatment.
干预措施: Tomando Control-Nurse (Behavioral)
Enhanced Engagement-Nurse
Tomando Control de su Diabetes-Nurse is a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by licensed nurses working with individual patients and families. If subjects do not benefit sufficiently, the subject may be randomized to receive three home visits to facilitate engagement with treatment.
干预措施: Enhanced engagement (Behavioral)
Enhanced Engagement-Promotora
Tomando Control de su Diabetes-Promotora is a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by licensed nurses working with individual patients and families. If subjects do not benefit sufficiently, the subject may be randomized to receive three home visits to facilitate engagement with treatment.
干预措施: Tomando Control-Promotora (Behavioral)
Enhanced Engagement-Promotora
Tomando Control de su Diabetes-Promotora is a culturally tailored, community-based, Diabetes Self-Management program delivered in a group format by licensed nurses working with individual patients and families. If subjects do not benefit sufficiently, the subject may be randomized to receive three home visits to facilitate engagement with treatment.
干预措施: Enhanced engagement (Behavioral)
Multifamily Group-Promotora
If subjects do not benefit sufficiently from the initial Tomando Control intervention offered by the promotoras, they may be randomized to receive a multifamily group intervention consisting of three components: three initial "joining" sessions conducted with each of the families separately; a one-day (six hour) educational workshop; and ongoing multifamily group sessions.
干预措施: Tomando Control-Promotora (Behavioral)
Multifamily Group-Promotora
If subjects do not benefit sufficiently from the initial Tomando Control intervention offered by the promotoras, they may be randomized to receive a multifamily group intervention consisting of three components: three initial "joining" sessions conducted with each of the families separately; a one-day (six hour) educational workshop; and ongoing multifamily group sessions.
干预措施: Multifamily Group (Behavioral)
Multifamily Group-Nurses
If subjects do not benefit sufficiently from the initial Tomando Control intervention offered by the nurses, they may be randomized to receive a multifamily group intervention consisting of three components: three initial "joining" sessions conducted with each of the families separately; a one-day (six hour) educational workshop; and ongoing multifamily group sessions.
干预措施: Tomando Control-Nurse (Behavioral)
Multifamily Group-Nurses
If subjects do not benefit sufficiently from the initial Tomando Control intervention offered by the nurses, they may be randomized to receive a multifamily group intervention consisting of three components: three initial "joining" sessions conducted with each of the families separately; a one-day (six hour) educational workshop; and ongoing multifamily group sessions.
干预措施: Multifamily Group (Behavioral)
结局指标
主要结局
Change in Diabetes Self-Management Behaviors (Revised Summary of Diabetes Self-Care Activities)
时间窗: This outcome measure will be assessed at baseline, six weeks, three months, six months and 12 months. The primary outcome is change from baseline as compared to the subsequent assessment points.
This 11-item scale assesses ADA-recommended health activities in diet, exercise, glucose self-monitoring, medication adherence and foot care. The mean number of days in the past week that activities are performed is calculated on a scale of 0-7; a high mean score indicates better diabetes self-management.
次要结局
- Diabetes Self-Efficacy (Stanford Self-Efficacy Scale)(This outcome measure will be assessed at baseline, three months, six months and 12 months.)
- Diabetes knowledge (Spoken Knowledge in Low Literacy Patients with Diabetes scale)(This outcome measure will be assessed at baseline, three months, six months and 12 months.)
- Family Support (Diabetes Family Support Behavior Checklist)(This outcome measure will be assessed at baseline, three months, six months and 12 months.)
- Collaborative goal setting (Patient Assessment of Chronic Illness Care)(This outcome measure will be assessed at baseline, three months, six months and 12 months.)
- Glycemic control(This outcome measure will be assessed at baseline, three months, six months and 12 months.)
研究者
Alex Kopelowicz, M.D.
Professor of Psychiatry
University of California, Los Angeles