An Integrative Online Diabetes Self-Management Education and Support Intervention Featuring Tai Chi Easy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Study Feasibility: Retention
研究概览
简要总结
The purpose of this project is to increase access to diabetes care and education for adults aged 40-64 years old who are diagnosed with Type 2 Diabetes Mellitus and are unable to attend education and support classes due to their work situation. This project will use an established, well-known program for Diabetes Self-Management Education and Support (DSMES) and combine it with Tai Chi Easy (TCE)™ to enhance physical health, psychological health, and health behaviors. Participants will be asked to attend 45 minutes of DSMES and 45 min of TCE twice a week for 6 weeks. All classes will be recorded and available online and can viewed at a time when it is most convenient to accommodate working adults. Participants will be asked to complete survey questionnaires online, at the beginning and end of the program; and have a smart phone to connect with a smart ring during the 6-week DSMES+TCE program. After the program is done, participants will be asked to return the smart ring. Upon receipt of the smart ring, they will receive a give a gift card to thank them for their participation in the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with T2DM
- •any sex/gender
- •any race/ethnicity
- •any socioeconomic group
- •has a smartphone
- •receives care in a Federally Qualified Healthcare Center in Southern Arizona
排除标准
- •Individuals with T1DM
- •Individuals with gestational DM
- •Individuals with pre-diabetes
- •pregnant women
- •Individuals unable to provide informed consent
- •Individuals with other serious co-occurring health condition (e.g., active cancer treatment)
结局指标
主要结局
Study Feasibility: Retention
时间窗: pre and post intervention at 6-weeks
number of participants that completed all aspects of the study (data collection pre-post intervention and study intervention) Goal: 80% study retention
Study Feasibility: Intervention acceptability
时间窗: post-intervention at 6-weeks
The Acceptability of Intervention Measure (AIM) is brief and contains 4-items using a 5-point Likert scale (possible scores 4-20), with higher scores indicating greater acceptability of the intervention. Adequate reliability and validity have been reported. Benchmark: at least 75% intervention acceptability, across sites.
Study Feasibility: Recruitment
时间窗: screening pre-intervention
the proportion of respondents who remained interested in the study after information and screening. Goal: recruit 10 participants per month for 3 months.
Study Feasibility: Intervention feasibility
时间窗: post-intervention at 6-weeks
The Feasibility of Intervention Measure (FIM) is brief and contains 4-items using a 5-point Likert scale (possible scores 4-20), with higher scores indicating greater feasibility of the intervention. Adequate reliability and validity have been reported. Benchmark: at least 75% intervention feasibility, across sites.
Study Feasibility: Intervention appropriateness
时间窗: post-intervention at 6-weeks
The Intervention Appropriateness Measure (IAM) is brief and contains 4-items using a 5-point Likert scale (possible scores 4-20), with higher scores indicating greater appropriateness of the intervention. Adequate reliability and validity have been reported. Benchmark: at least 75% intervention appropriateness, across sites.
Study Feasibility: Intervention safety
时间窗: during the 6-week intervention
number of adverse events during the intervention. Goal: no safety issues or adverse events
次要结局
- self-reported physical health: Blood Pressure(pre-intervention (self-report))
- self-reported physical health: Waist Circumference(pre-intervention (self-report))
- self-reported physical health: Hemoglobin A1C(pre-intervention (self-report))
- self-reported physical health: Weight(pre-intervention (self-report))
- perceived psychological health: Posttraumatic Stress Scale-Civilian Version(pre and post-intervention at 6-weeks)
- health behaviors: Dietary Screener Questionnaire(pre and post-intervention at 6-weeks)
- self-reported physical health: Height(pre-intervention (self-report))
- perceived psychological health: Diabetes Quality of Life Questionnaire(pre and post-intervention at 6-weeks)
- health behaviors: Rapid Assessment of Physical Activity(pre and post-intervention at 6-weeks)
- self-reported physical health: Blood Sugar(pre-intervention (self-report))
- Objective measures using an Oura Ring: Physical Activity(during the 6-week intervention)
- Objective measures using an Oura Ring: Heart Rate Variability(during the 6-week intervention)
- perceived psychological health: Diabetes Distress Scale(pre and post-intervention at 6-weeks)
- perceived psychological health: Patient Health Questionnaire-9(pre and post-intervention at 6-weeks)
- perceived psychological health: Perceived Stress Scale(pre and post-intervention at 6-weeks)
- Objective measures using an Oura Ring: Sleep(during the 6-week intervention)