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Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support

NCT03812614 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2025-02-13

Study results available
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Summary

The objective of this study is to compare the effectiveness of a novel program-Family Support for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management education and support (I-DSMES).

Conditions

Interventions

BEHAVIORAL

FAM ACT

Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.

BEHAVIORAL

I-DSMES

Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.

Sponsors & Collaborators

  • The Community Health and Social Services Center, Inc.

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Ann-Marie Rosland, MD,MS · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812614 on ClinicalTrials.gov