Feasibility of a Complex Behavioral Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
Feasibility of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study will evaluate the feasibility of implementing a diabetes management intervention via telehealth in preparation for a large-scale randomized controlled trial (RCT) entitled Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study.
详细描述
Feasibility of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) feasibility study will evaluate the feasibility of implementing a diabetes management intervention via telehealth in preparation for a large-scale RCT.
Young adulthood is a challenging life stage for many individuals with diabetes; only 17% of YAs age 18-25 and 30% age 26-30 attain recommended A1C targets, and fewer than 1/3 perform self-care in accordance with national guidelines. Yet, it is a crucial stage for establishing health habits that persist throughout adulthood. To address these issues, our research team developed REAL Diabetes (Resilient, Empowered, Active Living with Diabetes), a 6-month individually tailored occupational therapy intervention focused on incorporating diabetes self-care into participants' daily habits and routines, and evaluated its efficacy in a pilot randomized controlled trial (n=81). REAL was shown in intention-to-treat analysis to significantly improve A1C (0.9% reduction; p=0.01) and diabetes-related quality of life (p=0.04). While REAL was highly promising in terms of its positive impact on health and quality of life, the intervention was delivered through home visits, limiting its potential for broad dissemination. Given that our target population experiences significant logistical barriers to clinic attendance (the impetus for our in-home treatment model), we therefore will adapt REAL to be delivered via telehealth (REAL-T), a highly promising care delivery model, and evaluate REAL-T in a large-scale RCT.
The current feasibility study will evaluate the feasibility of implementing the REAL-T intervention via telehealth by enrolling 10 participants who are 18-30 years of age, conducting the REAL-T intervention with all participants over a 3-month period, and assessing the process of implementing the study (feasibility and participant satisfaction).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with either type 1 diabetes or type 2 diabetes for at least 12 months
- •Hemoglobin A1C >7.5%
- •Resident of Los Angeles County with no imminent plans to relocate
- •Fluent in English
- •Previous participant in REAL Diabetes Study
排除标准
- •Pregnant or planning to become pregnant within the next 4 months
- •Diagnosed with a comorbid cognitive or intellectual disability
研究组 & 干预措施
REAL-T Intervention
The current feasibility study will evaluate the feasibility of implementing the REAL-T RCT by enrolling 10 participants who are 18-30 years of age, conducting the REAL-T intervention with all participants over a 3-month period, evaluating pre-to-post changes in their health and quality of life, and assessing the process of implementing the study (feasibility and participant satisfaction).
干预措施: REAL-T Intervention (Behavioral)
结局指标
主要结局
Feasibility
时间窗: 3 months
Both formative and summative data will be gathered throughout the study to assess feasibility, defined herein as the extent to which the intervention can be successfully delivered via telehealth. Feasibility will be assessed through surveys.
Acceptability
时间窗: 3 months
Both formative and summative data will be gathered throughout the study to assess acceptability, defined herein as the perception of the intervention as agreeable/satisfactory. Acceptability will be assessed through interviews.
次要结局
- Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention(Baseline, 3 months)
- Change from baseline in Patient Health Questionnaire-8 (PHQ-8) survey at post-intervention(Baseline, 3 months)
- Change from baseline in The Diabetes Empowerment Scale-Short Form (DES-SF) at post-intervention(Baseline, 3 months)
- Change from baseline in Problem Areas in Diabetes (PAID) survey at post-intervention(Baseline, 3 months)
- Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention(Baseline, 3 months)
- Change from baseline in Glycated hemoglobin (HbA1C) at post-intervention(Baseline, 3 months)
研究者
Elizabeth Pyatak
Assistant Professor
University of Southern California
