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

NCT03333772 | Completed

• 1 other identifier: REAL-T Feasability
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Feasibility

  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

  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 Outcomes (6)

• Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) 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 Patient Health Questionnaire-8 (PHQ-8) survey at post-intervention

  Baseline, 3 months

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

  Baseline, 3 months

Study Arms (1)

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).

Behavioral: REAL-T Intervention

Interventions

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.

REAL-T Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC Center for Health Professionals

Los Angeles, California, 90033, United States

Location

Related Publications (5)

• Pyatak EA, Florindez D, Peters AL, Weigensberg MJ. "We are all gonna get diabetic these days": the impact of a living legacy of type 2 diabetes on Hispanic young adults' diabetes care. Diabetes Educ. 2014 Sep-Oct;40(5):648-58. doi: 10.1177/0145721714535994. Epub 2014 May 27.

  PMID: 24867918 BACKGROUND

• Pyatak EA, Sequeira PA, Whittemore R, Vigen CP, Peters AL, Weigensberg MJ. Challenges contributing to disrupted transition from paediatric to adult diabetes care in young adults with type 1 diabetes. Diabet Med. 2014 Dec;31(12):1615-24. doi: 10.1111/dme.12485. Epub 2014 May 26.

  PMID: 24798586 BACKGROUND

• Pyatak EA, Florindez D, Weigensberg MJ. Adherence decision making in the everyday lives of emerging adults with type 1 diabetes. Patient Prefer Adherence. 2013 Jul 29;7:709-18. doi: 10.2147/PPA.S47577. Print 2013.

  PMID: 23935361 BACKGROUND

• Pyatak EA, Carandang K, Davis S. Developing a Manualized Occupational Therapy Diabetes Management Intervention: Resilient, Empowered, Active Living With Diabetes. OTJR (Thorofare N J). 2015 Jul;35(3):187-94. doi: 10.1177/1539449215584310.

  PMID: 26594741 BACKGROUND

• Pyatak EA, Carandang K, Vigen C, Blanchard J, Sequeira PA, Wood JR, Spruijt-Metz D, Whittemore R, Peters AL. Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults. Contemp Clin Trials. 2017 Mar;54:8-17. doi: 10.1016/j.cct.2016.12.025. Epub 2017 Jan 5.

  PMID: 28064028 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elizabeth Pyatak, PhD, OTR/L

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 7, 2017
• Study Start: November 15, 2017
• Primary Completion: February 10, 2018
• Study Completion: February 10, 2018
• Last Updated: May 8, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)