Testing New Models of Diabetes Self-Management to Improve Population Health

NCT06370494 | Completed

• 1 other identifier: IRB2020-0956D
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome.

  A1C values will be treated continuously in analyses, with possible values ranging from 4 to 14 due to instrument precision at the higher values.

  12 months

Secondary Outcomes (5)

• Diabetes Knowledge: Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version).

  12 months

• Diabetes Self Care

  12 months

• Diabetes Care Confidence

  12 months

• Diabetes care distress

  12 months

• A1C

  12 months

Study Arms (3)

Virtual Making Moves with Diabetes [MMWD] Group

EXPERIMENTAL

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.

Behavioral: Living Healthier with Diabetes

App Group

EXPERIMENTAL

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.

Behavioral: Living Healthier with Diabetes

Combo Group

EXPERIMENTAL

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.

Behavioral: Living Healthier with Diabetes

Interventions

Living Healthier with Diabetes BEHAVIORAL

Interventions are different aspects of digital health utilizing American Diabetes Association recognized diabetes programs/applications or a combined approach. All participants were randomly assigned to their education arm and received an A1c kit, glucometer, testing strips, and surveys.

App Group; Combo Group; Virtual Making Moves with Diabetes [MMWD] Group

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas A&M University: lead
• Blue Cross Blue Shield: collaborator

Study Sites (1)

Texas A&M Health

College Station, Texas, 77843-1266, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marcia Ory

  Texas A&M Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regents and Distinguished Professor

Model Details: 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 Record Dates

• First Submitted: March 8, 2024
• First Posted: April 17, 2024
• Study Start: February 1, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)