Testing New Models of Diabetes Self-Management to Improve Population Health
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- 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.
- Status
- Completed
- Last Updated
- 2 years ago
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:
Investigators
Marcia G Ory
Regents and Distinguished Professor
Texas A&M University
Eligibility Criteria
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.
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)