Accessible and Inclusive Diabetes Telecoaching Self-Management Program: Protocol for a Feasibility Study
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
- Glycemic Management
研究概览
简要总结
The purpose of this study is to develop and pilot test an accessible and inclusive Artificial Intelligence (AI)-assisted, individualized, family-focused lifestyle modification intervention (AI4DM) for glycemic control in people with disabilities.
详细描述
The AI4DM study will use a two-arm randomized control trial design. Eligible and consented participants will be assigned to one of two groups: 1) AI4DM intervention group with telecoaching support, and 2) attention-control group. The active intervention period will include six months of weekly and bi-weekly telecoaching calls followed by six months of follow-up and technology access, but no telecoaching calls.
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 (Investigator, Outcomes Assessor)
盲法说明
The principal investigator and biostatistician will be masked to the randomization of the participants into the two treatment groups.
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 Type 2 Diabetes Mellitus,
- •Living with a permanent physical disability such as spinal cord injury (SCI), spina bifida, multiple sclerosis, stroke, etc.
- •Ability to converse and read in English
排除标准
- •Current enrollment in any diabetes-related intervention
- •Severe untreated depression in the past six months
- •Major cardiac event in the past twelve months
- •Uncontrolled blood pressure
- •Resting tachycardia
- •Renal failure
- •Severe peripheral neuropathy
- •Unavailability of a smartphone
结局指标
主要结局
Glycemic Management
时间窗: 48 weeks
Measured using HbA1c
次要结局
- Family Support(48 weeks)
- Medication Adherence(48 weeks)
- Self-efficacy(48 weeks)
- Health Information Technology(48 weeks)
- Telehealth Dashboard Usability(48 weeks)
- Health Technology Usability(48 weeks)
- Psychological distress(48 weeks)
- Diabetes Quality of life(48 weeks)
- Physical Activity(48 weeks)
- Dietary intake(48 weeks)
研究者
Mohanraj Thirumalai
Assistant Professor
University of Alabama at Birmingham