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临床试验/NCT03333772
NCT03333772已完成不适用

Feasibility of a Complex Behavioral Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study

University of Southern California2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2017年11月15日最近更新:
适应症
干预措施

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Pyatak

Assistant Professor

University of Southern California

研究点 (2)

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