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Medical Care, Education, Social Support, And Goal-setting to Empower Self-management for Diabetes (MESSAGES)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes MESSAGES Program
Diabetes MESSAGES Program (second trial)
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes Mellitus focused on measuring diabetes, group visit, shared medical appointment, text messaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • diagnosis of type 2 diabetes
  • attended at least two appointments at the HC within the past year, with at least one of them being during the past six months
  • last documented A1c result greater than or equal to 8.0% (test must have been done during the last 6 months)
  • own a cellular phone with text messaging capabilities
  • have the ability to read and send text messages
  • English or Spanish speaking

Exclusion Criteria:

  • pregnant or planning to become pregnant
  • uncontrolled psychiatric problem
  • dementia or other cognitive impairment
  • hearing difficulties or severe physical disability that would prevent them from participation in group visit
  • planning to relocate in the next year or leave the area during the group visit period

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

2018 Training Cohort

2020 Training Cohort

Arm Description

10 health centers will be randomized to the 2018 Training Cohort. Teams from these health centers will be trained and will implement a 6 month diabetes group visit and text messaging intervention (Diabetes MESSAGES Program).

10 health centers will be randomized to the 2020 Training Cohort. Prior to beginning training, these health centers will collect data on randomly selected patients receiving usual care to serve as the control group. After this first parallel group trial period, teams from these health centers will be trained and will implement the 6 month diabetes group visit and text messaging intervention during a second single group trial period (Diabetes MESSAGES Program (second trial)).

Outcomes

Primary Outcome Measures

Hemoglobin A1C

Secondary Outcome Measures

Hemoglobin A1C
Blood pressure
Weight
Cholesterol
Diabetes processes of care
Receipt of recommended screenings, exams, referrals, and vaccinations
Medication management of diabetes
changes in prescribed diabetes medications for patients with inadequate diabetes control
Number of hypoglycemic events
Number of hospital admissions
Number of primary care, specialist, and ER visits
Smoking status
Health related quality of life (SF-12)
Depression (PHQ-2)
Summary of Diabetes Self-Care Activities Measure
Understanding of Diabetes Self-Management (Diabetes Care Profile)
Attitudes Towards Diabetes (Diabetes Care Profile)
Diabetes Distress Scale (DDS-2)
Diabetes Quality of Life Scale
Diabetes Self-Empowerment Scale
Diabetes Social Support Scale
Patient satisfaction with intervention
CAHPS Overall Rating
Patient satisfaction with overall care at health center
CAHPS Cultural Competency
Patient satisfaction with cultural competency of care at health center
CAHPS Provider Communication
Patient satisfaction with provider communication at health center

Full Information

First Posted
March 21, 2018
Last Updated
November 1, 2022
Sponsor
University of Chicago
Collaborators
Midwest Clinicians' Network, CareMessage
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1. Study Identification

Unique Protocol Identification Number
NCT03487692
Brief Title
Medical Care, Education, Social Support, And Goal-setting to Empower Self-management for Diabetes
Acronym
MESSAGES
Official Title
Diabetes MESSAGES (Medical Care, Education, Social Support, And Goal-setting to Empower Self-management): Implementing Diabetes Group Visits and Text Messaging in Community Health Centers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Midwest Clinicians' Network, CareMessage

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Diabetes group visits, shared appointments where patients receive self-management education in a group setting and have a medical visit, are a promising way to deliver high quality diabetes care. Group visits can improve glycemic control and decrease healthcare utilization. To date, no studies have systematically implemented a diabetes group visit intervention in a network of U.S. community health centers. The University of Chicago is partnering with Midwest Clinicians' Network (MWCN), a member organization of 130 health centers across ten Midwestern states. Approximately half of all Federally Qualified Health Centers in this region are affiliated with MWCN. The objectives of the study are [1] providers and staff at 20 health centers will have the requisite knowledge, skills, and motivation to implement a diabetes group visit plus text messaging intervention at their sites; [2] changes in diabetes processes of care; knowledge, attitudes, and skills for diabetes self-management; clinical outcomes; and health care utilization for patients participating in the diabetes group visit program will be evaluated; and [3] the diabetes group visit program will be available for dissemination among and use by health centers and healthcare providers at the local, state, regional, and national levels.
Detailed Description
UChicago and MWCN will recruit and enroll 20 health centers (HCs) to participate in a training intervention and to implement diabetes group visit and text messaging programs at their clinic sites. Each HC will assemble a team of 3-4 providers and staff to participate in the training. HCs will be randomized to one of two training cohorts. HC providers and staff will attend two in-person Learning Sessions in Chicago and a series of monthly webinars, recruit and enroll patients, implement a 6-month diabetes group visit and text messaging program plus subsequent booster sessions, complete periodic surveys and interviews, assist with data collection through patient surveys and chart abstraction, and present their program to peer HCs during Learning Sessions and to local stakeholders, state primary care organizations, or other professional groups. Each HC will enroll 15 patients in the group visit and text messaging program; the 2018 Training Cohort will do so immediately following their enrollment in the study and the 2020 Training Cohort will do so after 18 months. During the first 18 months, the 2020 Training Cohort will collect data from electronic health records (EHR) of randomly selected patients to serve as a control group. Changes in self-reported outcomes, diabetes processes of care, and clinical outcomes will be assessed for intervention patients from baseline through 2 year follow up, and processes of care and clinical outcomes will be compared for intervention vs. control participants. Capacity of HC providers and staff to conduct a group visit and text messaging intervention for patients with diabetes, as well as their confidence in identifying and addressing health disparities, will be evaluated through surveys and in-depth interviews. This study will expand knowledge of the barriers, facilitators, and perceived benefits and drawbacks of group visit and text messaging interventions and inform the development of a toolkit that will be disseminated to other HCs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, group visit, shared medical appointment, text messaging

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2018 Training Cohort
Arm Type
Experimental
Arm Description
10 health centers will be randomized to the 2018 Training Cohort. Teams from these health centers will be trained and will implement a 6 month diabetes group visit and text messaging intervention (Diabetes MESSAGES Program).
Arm Title
2020 Training Cohort
Arm Type
Other
Arm Description
10 health centers will be randomized to the 2020 Training Cohort. Prior to beginning training, these health centers will collect data on randomly selected patients receiving usual care to serve as the control group. After this first parallel group trial period, teams from these health centers will be trained and will implement the 6 month diabetes group visit and text messaging intervention during a second single group trial period (Diabetes MESSAGES Program (second trial)).
Intervention Type
Other
Intervention Name(s)
Diabetes MESSAGES Program
Intervention Description
Health centers in the 2018 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient. At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program. Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
Intervention Type
Other
Intervention Name(s)
Diabetes MESSAGES Program (second trial)
Intervention Description
During the first trial period, health centers in the 2020 Training Cohort will collect data on patients receiving usual care. After the first trial period, health centers in the 2020 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient. At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program. Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
Primary Outcome Measure Information:
Title
Hemoglobin A1C
Time Frame
change from baseline to 12 months
Secondary Outcome Measure Information:
Title
Hemoglobin A1C
Time Frame
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Title
Blood pressure
Time Frame
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Title
Weight
Time Frame
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Title
Cholesterol
Time Frame
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Title
Diabetes processes of care
Description
Receipt of recommended screenings, exams, referrals, and vaccinations
Time Frame
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Title
Medication management of diabetes
Description
changes in prescribed diabetes medications for patients with inadequate diabetes control
Time Frame
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Title
Number of hypoglycemic events
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
Number of hospital admissions
Time Frame
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Title
Number of primary care, specialist, and ER visits
Time Frame
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Title
Smoking status
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
Health related quality of life (SF-12)
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
Depression (PHQ-2)
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
Summary of Diabetes Self-Care Activities Measure
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
Understanding of Diabetes Self-Management (Diabetes Care Profile)
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
Attitudes Towards Diabetes (Diabetes Care Profile)
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
Diabetes Distress Scale (DDS-2)
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
Diabetes Quality of Life Scale
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
Diabetes Self-Empowerment Scale
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
Diabetes Social Support Scale
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
Patient satisfaction with intervention
Time Frame
6 month and 12 month for intervention patients only
Title
CAHPS Overall Rating
Description
Patient satisfaction with overall care at health center
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
CAHPS Cultural Competency
Description
Patient satisfaction with cultural competency of care at health center
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Title
CAHPS Provider Communication
Description
Patient satisfaction with provider communication at health center
Time Frame
baseline, 6 month, and 12 month for intervention patients only
Other Pre-specified Outcome Measures:
Title
Patient engagement
Description
Attendance/participation in group visits, text messaging, and booster sessions
Time Frame
through study completion, an average of 2 years
Title
Health center provider/staff preparedness
Description
Capacity, confidence, motivation, perceived benefits and barriers
Time Frame
change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
Title
Health center provider/staff satisfaction
Description
Satisfaction with training, group visits, and text messaging
Time Frame
post-training (16 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older diagnosis of type 2 diabetes attended at least two appointments at the HC within the past year, with at least one of them being during the past six months last documented A1c result greater than or equal to 8.0% (test must have been done during the last 6 months) own a cellular phone with text messaging capabilities have the ability to read and send text messages English or Spanish speaking Exclusion Criteria: pregnant or planning to become pregnant uncontrolled psychiatric problem dementia or other cognitive impairment hearing difficulties or severe physical disability that would prevent them from participation in group visit planning to relocate in the next year or leave the area during the group visit period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arshiya Baig, MD, MPH
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Medical Care, Education, Social Support, And Goal-setting to Empower Self-management for Diabetes

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