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

1. listopadu 2022 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

265

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Illinois
      • Chicago, Illinois, Spojené státy, 60637
        • University of Chicago

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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).
Jiný: 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.
Jiný: 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)).
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
Hemoglobin A1C
Časové okno: change from baseline to 12 months
change from baseline to 12 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Hemoglobin A1C
Časové okno: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Blood pressure
Časové okno: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Weight
Časové okno: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Cholesterol
Časové okno: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Diabetes processes of care
Časové okno: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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
Medication management of diabetes
Časové okno: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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
Number of hypoglycemic events
Časové okno: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Number of hospital admissions
Časové okno: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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
Časové okno: baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
Smoking status
Časové okno: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Health related quality of life (SF-12)
Časové okno: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Depression (PHQ-2)
Časové okno: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Summary of Diabetes Self-Care Activities Measure
Časové okno: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Understanding of Diabetes Self-Management (Diabetes Care Profile)
Časové okno: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Attitudes Towards Diabetes (Diabetes Care Profile)
Časové okno: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Diabetes Distress Scale (DDS-2)
Časové okno: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Diabetes Quality of Life Scale
Časové okno: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Diabetes Self-Empowerment Scale
Časové okno: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Diabetes Social Support Scale
Časové okno: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Patient satisfaction with intervention
Časové okno: 6 month and 12 month for intervention patients only
6 month and 12 month for intervention patients only
CAHPS Overall Rating
Časové okno: baseline, 6 month, and 12 month for intervention patients only
Patient satisfaction with overall care at health center
baseline, 6 month, and 12 month for intervention patients only
CAHPS Cultural Competency
Časové okno: baseline, 6 month, and 12 month for intervention patients only
Patient satisfaction with cultural competency of care at health center
baseline, 6 month, and 12 month for intervention patients only
CAHPS Provider Communication
Časové okno: baseline, 6 month, and 12 month for intervention patients only
Patient satisfaction with provider communication at health center
baseline, 6 month, and 12 month for intervention patients only

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patient engagement
Časové okno: through study completion, an average of 2 years
Attendance/participation in group visits, text messaging, and booster sessions
through study completion, an average of 2 years
Health center provider/staff preparedness
Časové okno: change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
Capacity, confidence, motivation, perceived benefits and barriers
change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
Health center provider/staff satisfaction
Časové okno: post-training (16 month)
Satisfaction with training, group visits, and text messaging
post-training (16 month)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Chicago

Spolupracovníci

Midwest Clinicians' Network
CareMessage

Vyšetřovatelé

  • Vrchní vyšetřovatel: Arshiya Baig, MD, MPH, University of Chicago

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

18. října 2018

Primární dokončení (Aktuální)

15. května 2022

Dokončení studie (Aktuální)

30. června 2022

Termíny zápisu do studia

První předloženo

21. března 2018

První předloženo, které splnilo kritéria kontroly kvality

27. března 2018

První zveřejněno (Aktuální)

4. dubna 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. listopadu 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

1. listopadu 2022

Naposledy ověřeno

1. listopadu 2022

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Klinické studie na Diabetes MESSAGES Program

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