Type 2 Diabetes MellitusMESSAGESNCT03487692
Medical Care, Education, Social Support, And Goal-setting to Empower Self-management for Diabetes
A study testing Diabetes MESSAGES Program and Diabetes MESSAGES Program (second trial) in people with Type 2 Diabetes Mellitus, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Diabetes MESSAGES Program and Diabetes MESSAGES Program (second trial)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Diabetes MESSAGES Program, Diabetes MESSAGES Program (second trial)
- Keywords
- diabetes, group visit, shared medical appointment, text messaging
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes MESSAGES ProgramOther
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.
Diabetes MESSAGES Program (second trial)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 2018 Training Cohort | Experimental | 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). Receives: Other: Diabetes MESSAGES Program |
| 2020 Training Cohort | Other | 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)). Receives: Other: Diabetes MESSAGES Program (second trial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
Measured: change from baseline to 12 months
Secondary outcomes (23)
Hemoglobin A1C
Measured: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Blood pressure
Measured: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Weight
Measured: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Cholesterol
Measured: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Diabetes processes of care
Receipt of recommended screenings, exams, referrals, and vaccinations
Measured: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Medication management of diabetes
changes in prescribed diabetes medications for patients with inadequate diabetes control
Measured: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Number of hypoglycemic events
Measured: baseline, 6 month, and 12 month for intervention patients only
Number of hospital admissions
Measured: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Number of primary care, specialist, and ER visits
Measured: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Smoking status
Measured: baseline, 6 month, and 12 month for intervention patients only
Health related quality of life (SF-12)
Measured: baseline, 6 month, and 12 month for intervention patients only
Depression (PHQ-2)
Measured: baseline, 6 month, and 12 month for intervention patients only
Summary of Diabetes Self-Care Activities Measure
Measured: baseline, 6 month, and 12 month for intervention patients only
Understanding of Diabetes Self-Management (Diabetes Care Profile)
Measured: baseline, 6 month, and 12 month for intervention patients only
Attitudes Towards Diabetes (Diabetes Care Profile)
Measured: baseline, 6 month, and 12 month for intervention patients only
Diabetes Distress Scale (DDS-2)
Measured: baseline, 6 month, and 12 month for intervention patients only
Diabetes Quality of Life Scale
Measured: baseline, 6 month, and 12 month for intervention patients only
Diabetes Self-Empowerment Scale
Measured: baseline, 6 month, and 12 month for intervention patients only
Diabetes Social Support Scale
Measured: baseline, 6 month, and 12 month for intervention patients only
Patient satisfaction with intervention
Measured: 6 month and 12 month for intervention patients only
CAHPS Overall Rating
Patient satisfaction with overall care at health center
Measured: baseline, 6 month, and 12 month for intervention patients only
CAHPS Cultural Competency
Patient satisfaction with cultural competency of care at health center
Measured: baseline, 6 month, and 12 month for intervention patients only
CAHPS Provider Communication
Patient satisfaction with provider communication at health center
Measured: baseline, 6 month, and 12 month for intervention patients only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start18 Oct 2018
- Primary completion15 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Midwest Clinicians' Network, CareMessage
- Responsible party
- Sponsor
- Investigators
- Arshiya Baig, MD, MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487692
- Sponsor's protocol ID
- IRB17-1385
- Acronym
- MESSAGES
- Status last verified
- Nov 2022
- First submitted
- 21 Mar 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Staab EM, Campbell A, Schaefer CT, Quinn MT, Li J, Zhu M, Wan W, Baig AA. Diabetes MESSAGES: A Learning Collaborative to Support Community Health Centers in Implementing and Sustaining Group Visits. J Ambul Care Manage. 2025 Oct-Dec 01;48(4):215-227. doi: 10.1097/JAC.0000000000000536. Epub 2025 Aug 22.
PubMed 40842052
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03487692
- Acronym / sponsor ID
- MESSAGES / IRB17-1385
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, group visit, shared medical appointment, text messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Midwest Clinicians' Network, CareMessage
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2018 Training Cohort | Experimental | Other: Diabetes MESSAGES Program10 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). |
| 2020 Training Cohort | Other | Other: Diabetes MESSAGES Program (second trial)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)). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes MESSAGES ProgramHealth 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. | Other | 2018 Training Cohort |
| Diabetes MESSAGES Program (second trial)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. | Other | 2020 Training Cohort |
Primary outcome
Hemoglobin A1C
Time frame: change from baseline to 12 months
23 secondary outcomes
Hemoglobin A1C
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Blood pressure
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Weight
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Cholesterol
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Diabetes processes of care
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Medication management of diabetes
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Number of hypoglycemic events
Time frame: baseline, 6 month, and 12 month for intervention patients only
Number of hospital admissions
Time frame: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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
Smoking status
Time frame: baseline, 6 month, and 12 month for intervention patients only
Health related quality of life (SF-12)
Time frame: baseline, 6 month, and 12 month for intervention patients only
Depression (PHQ-2)
Time frame: baseline, 6 month, and 12 month for intervention patients only
Summary of Diabetes Self-Care Activities Measure
Time frame: baseline, 6 month, and 12 month for intervention patients only
Understanding of Diabetes Self-Management (Diabetes Care Profile)
Time frame: baseline, 6 month, and 12 month for intervention patients only
Attitudes Towards Diabetes (Diabetes Care Profile)
Time frame: baseline, 6 month, and 12 month for intervention patients only
Diabetes Distress Scale (DDS-2)
Time frame: baseline, 6 month, and 12 month for intervention patients only
Diabetes Quality of Life Scale
Time frame: baseline, 6 month, and 12 month for intervention patients only
Diabetes Self-Empowerment Scale
Time frame: baseline, 6 month, and 12 month for intervention patients only
Diabetes Social Support Scale
Time frame: baseline, 6 month, and 12 month for intervention patients only
Patient satisfaction with intervention
Time frame: 6 month and 12 month for intervention patients only
CAHPS Overall Rating
Time frame: baseline, 6 month, and 12 month for intervention patients only
CAHPS Cultural Competency
Time frame: baseline, 6 month, and 12 month for intervention patients only
CAHPS Provider Communication
Time frame: baseline, 6 month, and 12 month for intervention patients only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 40842052Staab EM, Campbell A, Schaefer CT, Quinn MT, Li J, Zhu M, Wan W, Baig AA. Diabetes MESSAGES: A Learning Collaborative to Support Community Health Centers in Implementing and Sustaining Group Visits. J Ambul Care Manage. 2025 Oct-Dec 01;48(4):215-227. doi: 10.1097/JAC.0000000000000536. Epub 2025 Aug 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arshiya Baig, MD, MPH principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes MESSAGES Program and Diabetes MESSAGES Program (second trial) in people with Type 2 Diabetes Mellitus, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (time frame: change from baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03487692, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.