Linking Self-Management and Primary Care for Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 463
- 试验地点
- 2
- 主要终点
- Improvement in health behaviors (e.g., dietary patterns, physical activity, medication taking) and biologic outcomes (HbA1c, lipid ratio, blood pressure, and smoking status).
研究概览
简要总结
This project is primarily a behavioral study. We employed a three-arm, patient-randomized practical effectiveness trial to evaluate the impact of two different interactive, multimedia self-management programs, relative to "enhanced" usual care. The two interventions will be (a) the revised program from our present study, based on our social-ecological theory and the 5 As self-management model, plus enhanced support (ASM+ES) that includes practical, but extensive, ongoing support and b) largely Automated Self-Management (ASM). These programs will be compared to a realistic "enhanced usual care" (UC) condition that will provide health risk appraisal feedback, control for computer interactions, and provide standardized advice on behavior change, but not the hypothesized key intervention processes of goal-setting, barriers identification, problem-solving, or social-environmental support. Patients will be randomized to conditions within clinic and will participate for 1 year.
The proposed project will test the effectiveness of a practical, automated-based intervention for primary care patients to facilitate dietary and physical activity practices, and medication-taking. Analyses will focus on primary outcomes of (a) dietary, physical activity, medication-taking outcomes, and (b) the UKPDS risk equation as well as secondary quality-of-life, patient-activation, and patient care outcomes (Specific Aim #2). Using the RE-AIM measures, we will analyze the reach, effectiveness, adoption, implementation, and maintenance of the intervention programs (Specific Aim #3), and also factors related to program implementation, linkage to primary care, and program success with emphasis on cost, cost-effectiveness, and mediators and moderators of outcomes such as social-environment support (Aim #4).
Primary hypotheses:
- That the Automated Intervention received by Automated self-management (ASM) condition and ASM plus enhanced support conditions (ASM+ES) will be superior to usual care on the primary outcomes.
- That the ASM+ES condition will be superior to the ASM alone condition on primary outcomes at the 12-month follow-up.
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
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •being 25-75 years of age,
- •live independently,
- •have a telephone,
- •are able to read in either English or Spanish,
- •able to access the Internet at least twice per week
- •are capable of providing informed consent,
- •have been diagnosed with type 2 diabetes for at least 1 year
- •are overweight (BMI ≥ 25), and
- •have at least one additional UKPDS equation risk factor (i.e., high lipids, hypertension, HbA1c, or smoking)
排除标准
- •Exclusion criteria:
- •Suffering dementia or active psychosis,
- •Being on end-stage dialysis,
- •or predicted to live fewer than 2 years
- •Being institutionalized.
- •Pregnant women - women with gestational diabetes will not be enrolled, because there needs are quite different, but we won't specifically exclude women who are pregnant AND otherwise eligible, since we do acknowledge that it's possible that someone may be unaware that they are pregnant at the time of enrollment, or may become pregnant during the study, and that this will not affect their continued participation.
结局指标
主要结局
Improvement in health behaviors (e.g., dietary patterns, physical activity, medication taking) and biologic outcomes (HbA1c, lipid ratio, blood pressure, and smoking status).
时间窗: Baseline, 4 months and 12 months
次要结局
- Diabetes-specific quality of life (Diabetes Distress Scale), patient activation (PAM scale), and perceived social-environmental support (the Chronic Illness Resources Survey) at 4- and 12-month follow-ups.(4 and 12 months)