Clinical trial NCT03333772: Feasibility of Delivering a Complex Behavioral Intervention for Young Adults With Diabetes Via Telehealth
Official title: Feasibility of a Complex Behavioral Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: 3 months
measure: Acceptability
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention
timeFrame: Baseline, 3 months
measure: Change from baseline in The Diabetes Empowerment Scale-Short Form (DES-SF) at post-intervention
timeFrame: Baseline, 3 months
measure: Change from baseline in Problem Areas in Diabetes (PAID) survey at post-intervention
timeFrame: Baseline, 3 months
measure: Change from baseline in Patient Health Questionnaire-8 (PHQ-8) survey at post-intervention
timeFrame: Baseline, 3 months
measure: Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention
timeFrame: Baseline, 3 months
measure: Change from baseline in Glycated hemoglobin (HbA1C) at post-intervention
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Center for Health Professionals
state: California
Study officials:
affiliation: University of Southern California
name: Elizabeth Pyatak, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.