Testing New Models of Diabetes Self-Management to Improve Population Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Texas A&M University
- Enrollment
- 191
- Locations
- 1
- Primary Endpoint
- A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome.
Study Overview
Brief Summary
Aim 1.1 To understand if diabetes self-management education and support (DSMES) improves diabetes-related outcomes among those with Type 2 diabetes living in Texas.
Aim 1.2 To examine how rurality affects study participation, engagement in, and effectiveness of different education interventions.
These aims are based on a randomized controlled trial of different evidence-based diabetes self-management interventions.
Detailed Description
A randomized controlled trial (RCT) was conducted to assess the outcomes associated with different technological intervention approaches. This 3-arm RCT assessed independent and combined interventions:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Type 2 diabetes mellitus (T2DM) - self-reported diagnosis by a health care provider
- •HbA1c value greater than or equal to 7.5%
- •Adults ages 25 years and older
- •All genders
- •Have access to device (smartphone/tablet which meets iOS 13 or above or similar system requirements/iPhone 7 and above or Android 6 and above) and internet in order to view online diabetes education content
- •Ability to read and speak English
- •Resides in Texas
Exclusion Criteria
- •Pregnant women
- •Participation in ADA-recognized or AADE-accredited diabetes self-management education program lasting at least eight hours within previous six months
- •Engagement with ADA-recognized or AADE-accredited smartphone application with certified diabetes educators providing tracking and health coaching within the previous six months
- •Those diagnosed with any conditions listed below (determined by self-report): Liver failure, End-stage renal disease (stage 4 or 5), Congestive heart failure (grade C or D), Organ transplant or bone marrow transplant, Cystic fibrosis, Malignant neoplasm or bone marrow transplant
- •Criteria excludes individuals based on language. Participants must be able to read and speak English. Technology-based education and support (TBES) is available only in English.
Arms & Interventions
Virtual Making Moves with Diabetes [MMWD] Group
Virtual asynchronous training and periodic one-on-one counseling with a clinical diabetes educator, either a Registered Nurse (RN) or Registered Dietitian Nutritionist (RDN). The program was recognized by the American Diabetes Association during this study. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, and 3 and 6-month follow-ups.
Intervention: Living Healthier with Diabetes (Behavioral)
App Group
Smartphone application for more continuous but less structured chat support. This app was recognized by the American Diabetes Association. The intervention included access to online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups.
Intervention: Living Healthier with Diabetes (Behavioral)
Combo Group
A combined approach for maximal support and reinforcement. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, access to the app with online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups.
Intervention: Living Healthier with Diabetes (Behavioral)
Outcomes
Primary Outcomes
A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome.
Time Frame: 12 months
A1C values will be treated continuously in analyses, with possible values ranging from 4 to 14 due to instrument precision at the higher values.
Secondary Outcomes
- Diabetes Knowledge: Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version).(12 months)
- Diabetes Care Confidence(12 months)
- A1C(12 months)
- Diabetes Self Care(12 months)
- Diabetes care distress(12 months)
Investigators
Marcia G Ory
Regents and Distinguished Professor
Texas A&M University