CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,085 enrolled
Drug / intervention
Standardized SMA +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/NCT03590041
NCT03590041N/ACompleted

Invested in Diabetes: Comparing Patient-Centered Outcomes of Standardized Versus Patient-Driven Diabetes Shared Medical Appointments (PCORI IHS-1609-36322)

University of Colorado, Denver·interventional·Posted Jul 18, 2018·Updated Apr 6, 2025

In Brief

A clinical study evaluating Standardized SMA and Patient-driven SMA for Diabetes Mellitus, Type 2. Completed, enrolled 1,085 participants across 1 site.

Detailed Summary

In this study, the investigators will compare the effectiveness of patient-driven diabetes Shared Medical Appointments (SMAs) to standardized diabetes SMAs. The curriculum to be used is Targeted Training for Illness Management (TTIM), a 6-session modular group intervention for chronic illness self-management, and has been tested in diabetes. The standardized group visit model will consist of diabetes SMAs with the full TTIM 6-session curriculum, led by a health educator.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 18, 2018
Enrollment StartJan 4, 2019
Primary CompletionDec 20, 2021
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.0 years ago

Interventions

Standardized SMAbehavioral

Patients receiving the Standardized SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, delivered only by health educators. The Standardized SMA approach will be uniformly administered at each practice. Topics will be covered in a predetermined order and patients will not have a say in terms of what content they wish to cover. Patients receive the Standardized SMA approach if their practice is randomly assigned to the Standardized SMA arm. Practices are cluster-randomized to deliver a standardized or patient-driven group visit model.

Patient-driven SMAbehavioral

Patients receiving the Patient-driven SMA intervention will be part of group visits that cover a modified TTIM 6-session curriculum, but patients are in control of time spent and order of the topics. The Patient-driven SMA will be delivered by a multidisciplinary team consisting of a Health Educator, medical provider, Behavioral Health Professional, and a diabetes peer mentor. Patient-driven SMAs may be delivered differently at each practice, as patients choose the topics that are most important to spend the most time on. All topics will be covered, but the order and time spent is up to the group. Patients receive the Patient-driven SMA approach if their practice is randomly assigned to that arm. Practices are cluster-randomized to deliver a standardized or patient-driven SMA model.