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

Type 2 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487692
• Other study ID #: IRB17-1385
• Status: Completed
• Phase: N/A
• Start date: October 18, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: June 30, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• Diabetes MESSAGES Program
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)
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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	CareMessage, Midwest Clinicians' Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient engagement	Attendance/participation in group visits, text messaging, and booster sessions	through study completion, an average of 2 years
Other	Health center provider/staff preparedness	Capacity, confidence, motivation, perceived benefits and barriers	change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
Other	Health center provider/staff satisfaction	Satisfaction with training, group visits, and text messaging	post-training (16 month)
Primary	Hemoglobin A1C		change from baseline to 12 months
Secondary	Hemoglobin A1C		baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Secondary	Blood pressure		baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Secondary	Weight		baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Secondary	Cholesterol		baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Secondary	Diabetes processes of care	Receipt of recommended screenings, exams, referrals, and vaccinations	baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Secondary	Medication management of diabetes	changes in prescribed diabetes medications for patients with inadequate diabetes control	baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Secondary	Number of hypoglycemic events		baseline, 6 month, and 12 month for intervention patients only
Secondary	Number of hospital admissions		baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Secondary	Number of primary care, specialist, and ER visits		baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Secondary	Smoking status		baseline, 6 month, and 12 month for intervention patients only
Secondary	Health related quality of life (SF-12)		baseline, 6 month, and 12 month for intervention patients only
Secondary	Depression (PHQ-2)		baseline, 6 month, and 12 month for intervention patients only
Secondary	Summary of Diabetes Self-Care Activities Measure		baseline, 6 month, and 12 month for intervention patients only
Secondary	Understanding of Diabetes Self-Management (Diabetes Care Profile)		baseline, 6 month, and 12 month for intervention patients only
Secondary	Attitudes Towards Diabetes (Diabetes Care Profile)		baseline, 6 month, and 12 month for intervention patients only
Secondary	Diabetes Distress Scale (DDS-2)		baseline, 6 month, and 12 month for intervention patients only
Secondary	Diabetes Quality of Life Scale		baseline, 6 month, and 12 month for intervention patients only
Secondary	Diabetes Self-Empowerment Scale		baseline, 6 month, and 12 month for intervention patients only
Secondary	Diabetes Social Support Scale		baseline, 6 month, and 12 month for intervention patients only
Secondary	Patient satisfaction with intervention		6 month and 12 month for intervention patients only
Secondary	CAHPS Overall Rating	Patient satisfaction with overall care at health center	baseline, 6 month, and 12 month for intervention patients only
Secondary	CAHPS Cultural Competency	Patient satisfaction with cultural competency of care at health center	baseline, 6 month, and 12 month for intervention patients only
Secondary	CAHPS Provider Communication	Patient satisfaction with provider communication at health center	baseline, 6 month, and 12 month for intervention patients only