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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06370494
• Other study ID #: IRB2020-0956D
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2024
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Living Healthier with Diabetes
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.

Locations

Country	Name	City	State
United States	Texas A&M Health	College Station	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	Blue Cross Blue Shield

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diabetes Knowledge: Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version).	Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version). 10 True False questions will be included with answers of True, False, and I don't know. Correct responses receive 1 point indicating a range of 0-10 points for this outcome measure.	12 months
Secondary	Diabetes Self Care	Diabetes self-management behavior will be measured by the adapted Summary of Diabetes Self-Care Activities Measure (SDSCA). The SDSCA is a brief self-report questionnaire that includes items assessing the following aspects of the diabetes regimen: general diet, specific exercise, blood-glucose testing, foot care, alcohol, and smoking. The scale has been adapted to examine self-care activities before and since COVID-19. Furthermore, a question about alcohol drinking has been added. Diabetes Self-care is the number of days a participant performed certain activities pertaining to diabetes care in a typical week. The diabetes self care scale is 8 questions asking how many days per week a participant engaged in a behavior on a scale of 0-7 days. Therefore, the scale ranged from 0-56 points, with higher points indicating greater occurrence of diabetes self care.	12 months
Secondary	Diabetes Care Confidence	Confidence in doing specific activities related to diabetes will be measured by the Self-Efficacy for Diabetes Scale. The scale is a self-report instrument that asks how confident individuals feel doing specific activities related to diabetes (e.g., diet, exercise, blood sugar monitoring).Diabetes confidence is how confident a participant is in their own ability to perform certain activities. To analyze this, a sum of 8 questions was taken. Diabetes confidence scale is 8 questions on scale of 1-10 ranging from ("not at all confident" to "totally confident"). The higher the sum is, the higher the confidence. Therefore, final outcome scores will range from 8-80, with higher scores indicating greater confidence in diabetes management.	12 months
Secondary	Diabetes care distress	Distress related to living with diabetes will be measured by the 2-item Diabetes Distress Screening Scale (DDS2). The DDS2 asks participants to rate the degree to which of perceived magnitudes of problems concerning diabetes that may have distressed or bothered participants. Diabetes distress is how distress a participant is in performing activities pertaining to diabetes care. Diabetes distress scale is 6 questions on a scale of 1-6 ranging from ("not a problem" to "a very serious problem"). To analyze this, a sum of 6 questions was taken. The higher the sum is, the more distressed the participant is. Therefore, the scale ranged from 6-36 points, with higher points more diabetes distress.	12 months
Secondary	A1C	-Number of participants with A1c reduction that is at least .5 (clinically significant). In addition to the continuous A1C measurements, an indicator variable will be created to indicate a clinically meaningful change (e.g., whether A1C dropped more than 0.5 at the 6-month). Possible A1c values ranging from 4 to 14 due to instrument precision at the higher values.	12 months