Clinical trial NCT06370494: Testing New Models of Diabetes Self-Management to Improve Population Health
Official title: Testing New Models of Diabetes Self-Management to Improve Population Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield
First posted: 2024-04-17
Enrollment: 191
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model 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:
Primary purpose: SUPPORTIVE_CARE

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:

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.

Primary outcomes:
measure: A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome.
timeFrame: 12 months
Secondary outcomes:
measure: Diabetes Knowledge: Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version).
timeFrame: 12 months
measure: Diabetes Self Care
timeFrame: 12 months
measure: Diabetes Care Confidence
timeFrame: 12 months
measure: Diabetes care distress
timeFrame: 12 months
measure: A1C
timeFrame: 12 months
Other outcomes:
Locations:
city: College Station
country: United States
facility: Texas A&M Health
state: Texas
Study officials:
affiliation: Texas A&M Health
name: Marcia Ory
role: PRINCIPAL_INVESTIGATOR
References: