Feasibility of Delivering a Complex Behavioral Intervention for Young Adults With Diabetes Via Telehealth
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 30 |
| Updated: | 5/10/2018 |
| Start Date: | November 15, 2017 |
| End Date: | February 10, 2018 |
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.
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.
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).
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).
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
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