CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 444 enrolled
Drug / intervention
FAM ACT +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03812614
NCT03812614N/ACompleted
CompareCT.gov

Comparative Effectiveness of Adding Family Supporter Training to a CHW-Led Intervention to Improve Behavioral Management of Multiple Risk Factors for Diabetes Complications

University of Pittsburgh·interventional·Posted Jan 23, 2019·Updated Feb 13, 2025

In Brief

A clinical study evaluating FAM ACT and I-DSMES for Diabetes Mellitus and 3 related conditions. Completed, enrolled 444 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, High Blood Pressure, High Blood Sugar, Hypertension
CountriesUnited States
CollaboratorsThe Community Health and Social Services Center, Inc., University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 23, 2019
Enrollment StartSep 23, 2019
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 7.4 years ago

Interventions

FAM ACTbehavioral

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.

I-DSMESbehavioral

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.