Effects of a Mindfulness Intervention Delivered Within Diabetes Education on Diabetes-related Outcomes in Military Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress)
研究概览
简要总结
The purpose of this study is to see if adding Mindfulness training to diabetes education reduces feelings of stress and makes it easier to adhere to healthy behaviors that improve diabetes outcomes (such as hemoglobin A1c).
详细描述
Background: One million Veterans (25%) who receive health care through Veterans Health Administration (VHA) have diabetes and are therefore responsible for daily diabetes self-management (DSM). DSM is essential for glycemic control and prevention of potentially life threatening and disabling complications such as severe hypoglycemia, kidney failure, acute coronary syndrome and stroke. Importantly, 40% of individuals with diabetes suffer from diabetes-related distress (DRD) that interferes with their ability to sustain healthy self-management behaviors, and may be particularly problematic for Veterans who are at higher risk for comorbid negative emotional states such as depression and post-traumatic stress disorder.
Diabetes self-management education (DSME) has traditionally contained little content or skill-building directly related to stress management, leaving this critical component of diabetes self-management largely unaddressed in DSME. In the investigators' pilot work, the investigators have developed a brief stress management intervention known as Mind-STRIDE, which contains mindfulness training and home practice and is easily integrated into existing DSME. While the investigators have previously demonstrated the feasibility, patient acceptability, and initial efficacy of Mind-STRIDE, its effects on diabetes-related psychological and physiological patient outcomes remain unknown. There is, therefore, a critical need to determine the efficacy of this targeted mindfulness intervention for improving DRD, diabetes self-efficacy, DSM behaviors, and metabolic control of Veterans with diabetes in order to offer comprehensive, evidence-based DSME that improves Veteran-centric diabetes outcomes.
Objectives: The objectives of this study are to determine the efficacy of Mind-STRIDE for improving DRD, diabetes self-efficacy, DSM, and metabolic control, and to characterize distinctive Veteran experiences with DRD and Mind-STRIDE.
Methods: To achieve these objectives, the investigators will conduct a randomized controlled trial of 126 Veterans at a large VA medical center in southwest PA. Participants will be assigned to one of two study conditions: an experimental group that receives routine diabetes education plus Mind-STRIDE, or to a usual care group that receives diabetes education alone. DRD, diabetes self-efficacy, and DSM will be assessed using self-report questionnaires. Metabolic control (Hemoglobin A1c) will be assessed using standard laboratory procedures. Data will be collected at baseline, 12-weeks, and 24-weeks, and will be analyzed using mixed-effects models. Telephone interviews will be conducted at 15-weeks post-intervention in a subset of participants from the experimental group, and will be analyzed using modified Grounded Theory methods. Quantitative and qualitative findings will be compared and interpreted using Convergent Parallel Design.
Status: Assessments were completed 4/09/2020.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Referral to DSME class at VA Pittsburgh Healthcare System University Drive Campus (VAPHS UD)
- •Diagnosis of type 1 or type 2 diabetes
- •Hemoglobin A1C >7.0%
- •Problem Areas in "Diabetes Scale (PAID) -5" score =/ >3 or "Diabetes Distress Scale -2" =/>2 score indicating the presence of Diabetes-related Distress
排除标准
- •Documented cognitive impairment that would interfere with the ability to comprehend the informed consent and actively participate in the study
- •Previous attendance of VA DSME class within the past 12 months
- •Currently active mindfulness practice
结局指标
主要结局
Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress)
时间窗: baseline, 12 weeks and 24 weeks
A 20-item psychometrically validated self-report questionnaire on a 5 point Likert scale (0= not problem; 4= a serious problem). The scores are summed and multiplied by 1.25. Minimum value = 0; Maximum value = 100. Higher scores denote higher levels of diabetes related distress. The cutoff for significant distress is 33; a score of 40 is consistent with diabetes burn-out.
次要结局
- Body Weight(baseline, 12 weeks and 24 weeks)
- Blood Pressure(baseline, 12 weeks and 24 weeks)
- Patient Health Questionnaire (PHQ8)(baseline, 12 weeks and 24 weeks)
- Diabetes Self-efficacy Scale (DSES)(baseline, 12 weeks and 24 weeks)
- Hemoglobin A1c (A1C)(baseline, 12 weeks and 24 weeks)
- Mindfulness Attention and Awareness Scale (MAAS)(baseline, 12 weeks and 24 weeks)
- PTSD Checklist- Civilian Version (PCL-C)(baseline, 12 weeks and 24 weeks)
- Summary of Diabetes Self-Care Activities (SDSCA), General Diet(baseline, 12 weeks and 24 weeks)
- Summary of Diabetes Self-Care Activities (SDSCA), Specific Diet(baseline, 12 weeks and 24 weeks)
- Summary of Diabetes Self-Care Activities (SDSCA) Space Carbohydrates(baseline, 12 weeks and 24 weeks)
- Summary of Diabetes Self-Care Activities (SDSCA)- Exercise(baseline, 12 weeks, 24 weeks)
- Summary of Diabetes Self-Care Activities (SDSCA)- - Footcare(baseline, 12 weeks, 24 weeks)
- Summary of Diabetes Self-Care Activities (SDSCA)- Blood Glucose Testing(baseline, 12 weeks, 24 weeks)
- Summary of Diabetes Self-Care Activities (SDSCA)- - Smoking(baseline,12 weeks, 24 weeks)
- Summary of Diabetes Self-Care Activities (SDSCA)- - Medication Adherence(baseline, 12 weeks, 24 weeks)