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

May 2, 2018 updated by: Elizabeth Pyatak, University of Southern California

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC Center for Health Professionals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Behavioral: REAL-T Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 months
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
Baseline, 3 months
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
Baseline, 3 months
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
Baseline, 3 months
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
Baseline, 3 months
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
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

February 10, 2018

Study Completion (Actual)

February 10, 2018

Study Registration Dates

First Submitted

November 2, 2017

First Submitted That Met QC Criteria

November 3, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REAL-T Feasability

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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