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NCT Number: NCT03333772

Feasibility of Delivering a Complex Behavioral Intervention for Young Adults With Diabetes Via Telehealth

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USC Center for Health Professionals

Los Angeles, California, 90033, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnant or planning to become pregnant within the next 4 months
  • Diagnosed with a comorbid cognitive or intellectual disability

Treatment and study plan

REAL-T Intervention

Behavioral

Individualized lifestyle intervention conducted via internet-based videoconferencing and incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants will have approximately 6-10 sessions lasting about one hour each, over a 3-month period.

Primary outcomes

  1. Feasibility

    Time frame: 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.

  2. Acceptability

    Time frame: 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.

Secondary outcomes

  1. Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention

    Time frame: Baseline, 3 months

    19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning

  2. Change from baseline in The Diabetes Empowerment Scale-Short Form (DES-SF) at post-intervention

    Time frame: Baseline, 3 months

    8 item survey measure assessing the psychosocial self-efficacy of people with diabetes

  3. Change from baseline in Problem Areas in Diabetes (PAID) survey at post-intervention

    Time frame: Baseline, 3 months

    5 item survey measure assessing diabetes-related stress

  4. Change from baseline in Patient Health Questionnaire-8 (PHQ-8) survey at post-intervention

    Time frame: Baseline, 3 months

    8-item survey measure assessing severity of depressive symptoms

  5. Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention

    Time frame: Baseline, 3 months

    14 item survey assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes

  6. Change from baseline in Glycated hemoglobin (HbA1C) at post-intervention

    Time frame: Baseline, 3 months

    Measure of average blood glucose concentration over approximately the previous 12 weeks

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2017
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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