Medical Nutrition Therapy and Diabetes Self-Management Education for People With Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Psychological Distress
研究概览
简要总结
The purpose of this project is to develop, and pilot test an accessible and inclusive medical nutrition therapy and diabetes self-management education program for people with Type 2 Diabetes and physical disabilities.
详细描述
This study will use a three-arm randomized control trial design. Eligible and consented participants will be assigned to one of three groups: (1) intervention with high-tech support, (2) intervention with low-tech support, and (3) attention-control group. The active intervention period will include six months of weekly health coaching calls and technology access. The low-tech support group will receive six months of weekly coaching calls and weekly email containing related materials in PDF format but no video and technology content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T2DM
- •18 to 65 years of age
- •Living with a permanent physical disability such as SCI, spina bifida, multiple sclerosis, stroke
- •Ability to converse in and read English
- •Availability of a smartphone or computer that can run apps
- •Have internet connection capabilities
排除标准
- •Current enrollment in any diabetes related intervention
- •Present or soon-planned pregnancy
- •Major heart attack or heart surgery in the past 12 months
- •Have undergone a dialysis, kidney transplant or a kidney surgery in the past 12 months
- •Severe cognitive impairment
- •Severe untreated depression in the past 6 months
结局指标
主要结局
Psychological Distress
时间窗: 234 weeks
Measured using Diabetes Distress Scale (DDS); Minimum score = 1, maximum score = 6; Higher score represents worse outcome
Diabetes Quality of Life
时间窗: 24 weeks
Measured using the DQoL (Diabetes Quality of Life Measure) Questionnaire; Minimum score =1; maximum score = 5; Higher score represents worse outcome
Self-efficacy
时间窗: 24 weeks
Measured using Diabetes Empowerment Scale; Minimum score = 1; maximum score = 5; Higher score represents better outcome
次要结局
- Glycemic Management(24 weeks)
研究者
Mohanraj Thirumalai
Assistant Professor
University of Alabama at Birmingham