Clinical trial NCT04334109: Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations
Official title: Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-04-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in mean HbA1c (NGSP%) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Secondary outcomes:
measure: Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: 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
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: 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
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: 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
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention medical records abstraction
measure: 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
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: 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
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in mean triglycerides from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in mean blood glucose from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
measure: Change in diabetes self-management behaviors from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
measure: Change in diabetes self-efficacy from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
measure: Change in medication adherence from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
measure: Change in diabetes-related distress from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
measure: Change in diabetes-related quality of life from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
timeFrame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas for Medical Sciences Northwest
state: Arkansas
Study officials:
affiliation: UAMS
name: Pearl McElfish, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayberry LS, Felix HC, Hudson J, Curran GM, Long CR, Selig JP, Carleton A, Baig A, Warshaw H, Peyrot M, McElfish PA. Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model. Contemp Clin Trials. 2022 Oct;121:106921. doi: 10.1016/j.cct.2022.106921. Epub 2022 Sep 9.