- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03487692
Medical Care, Education, Social Support, And Goal-setting to Empower Self-management for Diabetes (MESSAGES)
1. november 2022 opdateret af: University of Chicago
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
265
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 2018 Training Cohort
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).
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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.
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Andet: 2020 Training Cohort
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)).
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Hemoglobin A1C
Tidsramme: change from baseline to 12 months
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change from baseline to 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Hemoglobin A1C
Tidsramme: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Blood pressure
Tidsramme: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Weight
Tidsramme: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Cholesterol
Tidsramme: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Diabetes processes of care
Tidsramme: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Receipt of recommended screenings, exams, referrals, and vaccinations
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Medication management of diabetes
Tidsramme: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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changes in prescribed diabetes medications for patients with inadequate diabetes control
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Number of hypoglycemic events
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Number of hospital admissions
Tidsramme: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Number of primary care, specialist, and ER visits
Tidsramme: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Smoking status
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Health related quality of life (SF-12)
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Depression (PHQ-2)
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Summary of Diabetes Self-Care Activities Measure
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Understanding of Diabetes Self-Management (Diabetes Care Profile)
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Attitudes Towards Diabetes (Diabetes Care Profile)
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Distress Scale (DDS-2)
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Quality of Life Scale
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Self-Empowerment Scale
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Social Support Scale
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with intervention
Tidsramme: 6 month and 12 month for intervention patients only
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6 month and 12 month for intervention patients only
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CAHPS Overall Rating
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with overall care at health center
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baseline, 6 month, and 12 month for intervention patients only
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CAHPS Cultural Competency
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with cultural competency of care at health center
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baseline, 6 month, and 12 month for intervention patients only
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CAHPS Provider Communication
Tidsramme: baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with provider communication at health center
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baseline, 6 month, and 12 month for intervention patients only
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Patient engagement
Tidsramme: through study completion, an average of 2 years
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Attendance/participation in group visits, text messaging, and booster sessions
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through study completion, an average of 2 years
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Health center provider/staff preparedness
Tidsramme: change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
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Capacity, confidence, motivation, perceived benefits and barriers
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change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
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Health center provider/staff satisfaction
Tidsramme: post-training (16 month)
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Satisfaction with training, group visits, and text messaging
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post-training (16 month)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Arshiya Baig, MD, MPH, University of Chicago
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. oktober 2018
Primær færdiggørelse (Faktiske)
15. maj 2022
Studieafslutning (Faktiske)
30. juni 2022
Datoer for studieregistrering
Først indsendt
21. marts 2018
Først indsendt, der opfyldte QC-kriterier
27. marts 2018
Først opslået (Faktiske)
4. april 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. november 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. november 2022
Sidst verificeret
1. november 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB17-1385
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