Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations

February 15, 2024 updated by: University of Arkansas
The investigators will conduct a fully-powered, comparative effectiveness randomized controlled trial that includes up to 600 patients with type 2 diabetes (T2D) and 600 of their family members. Patients with T2D will be randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm, with 300 patients in each arm. In the Family-DSMES arm, one of each patient's family members will take part in the educational sessions (family members defined below). Baseline and follow-up data (immediate post-intervention, 6 months post-intervention, and 12 months post-intervention) will be collected from patients and family members in both study arms. In the Standard-DSMES arm, data will be collected from family members, but they will not participate in educational sessions. In both arms, the investigators will obtain a medical records release to abstract outcomes at 18 months post-intervention.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • University of Arkansas for Medical Sciences Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • adults ≥18 years of age
  • have T2D (HbA1c ≥ 7.0)
  • speak English
  • a family member willing to take part in the study

Exclusion Criteria:

  • have received formal DSME in the past three years
  • have a condition that makes it unlikely for them to be able to follow the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family-DSME

Approach

  • Family motivational interviewing techniques
  • Family goal setting
  • Understanding supportive and nonsupportive family behaviors
  • Family behavioral changes Mode of Delivery
  • Group sessions delivered by a certified diabetes educator (CDE) to patients and their family members Dosage
  • 10 hours delivered in one-hour sessions over 10 weeks Participants
  • 300 patients with T2D and 300 family members (family members will take part in educational sessions and data collection)
Family Diabetes Self-Management Education and Support demonstrates the effectiveness of family-centered models of DSME that explicitly address diabetes self-management within a family context by educating both patients and family members and focusing on family motivational interviewing, family goal setting, understanding supportive and nonsupportive behaviors, and family behavioral changes.
Active Comparator: Standard-DSME

Approach

  • Individual motivational interviewing techniques
  • Individual goal setting
  • Individual behavioral changes Mode of Delivery
  • Group sessions delivered by a CDE to patients Dosage
  • 10 hours delivered in one-hour sessions over 10 weeks Participants
  • 300 patients with T2D (family members will take part in data collection but not educational sessions)
Diabetes Self-Management Education and Support demonstrates the effectiveness of individual model DSMES that explicitly address diabetes self-management within an individual context by educating individual patients on individual motivational interviewing, individual goal setting, and individual behavioral changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean HbA1c (NGSP%) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
A Siemens analyzer will be utilized to calculate HbA1c (%) for each participant at every time point (except for 18 months post-intervention, which will be collected through medical record abstractions). Changes in the primary outcome measure will be assessed from baseline to each follow-up time point. The primary analytic approach will use general linear models, including mixed effects linear regression models for continuous repeated measures, to model the mean outcome difference and covariance structures between the treatment arms. Analyses will be adjusted for baseline differences in demographic, socioeconomic, and clinical variables, all within repeated mixed linear regression models. Clustering effects within the intervention delivery groups (i.e., within the DSMES classes) will be accounted for in the model as a random effect. We will adjust for potential clinic variations as a dummy coded variable in our model.
Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
BMI will be collected by measuring participant height (without shoes) using a stadiometer, and measuring participant weight (without shoes) using a calibrated digital scale. Weight and height will be used to compute a continuous measure of BMI. BMI at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean waist circumference from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention medical record abstraction
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Waist circumference will be collected by measuring participant's waist using a flexible tape measure. Waist circumference at 18 months post-intervention will be abstracted from participant medical records.The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean blood pressure (systolic & diastolic, mmHg) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Blood pressure will be measured with a sphygmomanometer and stethoscope or digital blood pressure device with the participant seated and arm elevated. Blood pressure at 18 months post-intervention will be abstracted from participant medical records.The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean total cholesterol (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention medical records abstraction
Through finger prick blood collection, point of care tests will be used used to test lipids using a commercial lipid panel kit and Cholestech LDX analyzer. Total cholesterol at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention medical records abstraction
Change in mean high-density lipoproteins (HDL) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Through finger prick blood collection, point of care tests will be used used to test HDL using a commercial lipid panel kit and Cholestech LDX analyzer. HDL at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean low-density lipoproteins (LDL) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Through finger prick blood collection, point of care tests will be used used to test HDL using a commercial lipid panel kit and Cholestech LDX analyzer. LDL Blood pressure at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean triglycerides from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Through finger prick blood collection, point of care tests will be used used to test triglycerides using a commercial lipid panel kit and Cholestech LDX analyzer. Triglycerides at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean blood glucose from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Through finger prick blood collection, point of care tests will be used used to test random blood glucose (not fasting). Blood glucose at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in diabetes self-management behaviors from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
The Summary of Diabetes Self-Care Activities (SDSCA) will be used to measure engagement in self-management activities. The SDSCA consists of 12 items to assess the self-reported frequency of performing diabetes self-care tasks, including testing blood sugar, following healthful eating plans, and exercising regularly. The SDSCA will be administered to participants at baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Change in diabetes self-efficacy from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
The Diabetes Management Self-Efficacy Scale (DMSES) will be used to measure patient's confidence in managing their diabetes. The DMSES consists of 20 items to assess self-reported confidence in managing aspects of their diabetes. The DMSES will be administered to participants at baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Change in medication adherence from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
The Adherence to Refills and Medications Scale for Diabetes Medicines (ARMS-D) will be used to measure patient's adherence to their medications (if prescribed). The ARMS-D consists of 11 items to assess self-reported adherence to diabetes medications. The ARMS-D will be administered to participants at baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Change in diabetes-related distress from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
The Problem Areas in Diabetes Scale (PAID)-5 will be used to measure diabetes distress. The PAID-5 consists of 5 items to assess self-reported diabetes-related emotional distress, including feeling scared or depressed. The PAID-5 will be administered to participants at baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Change in diabetes-related quality of life from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
The DAWN2 Impact of Diabetes Profile (DIDP) will be used to measure the perceived impact of diabetes on patients' quality of life. The DIDP consists of 6 items to assess self-reported impacts on quality of life, including physical health, financial situation, and relationships with others. The DIDP will be administered to participants at baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.
Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pearl McElfish, PhD, UAMS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Estimated)

July 2, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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