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

1 listopada 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

265

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60637
        • University of Chicago

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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).
Inny: 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.
Inny: 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)).
Inny: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Hemoglobin A1C
Ramy czasowe: change from baseline to 12 months
change from baseline to 12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Hemoglobin A1C
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Number of hospital admissions
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Depression (PHQ-2)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Diabetes Self-Empowerment Scale
Ramy czasowe: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Diabetes Social Support Scale
Ramy czasowe: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Patient satisfaction with intervention
Ramy czasowe: 6 month and 12 month for intervention patients only
6 month and 12 month for intervention patients only
CAHPS Overall Rating
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Patient engagement
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: post-training (16 month)
Satisfaction with training, group visits, and text messaging
post-training (16 month)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Chicago

Współpracownicy

Midwest Clinicians' Network
CareMessage

Śledczy

  • Główny śledczy: Arshiya Baig, MD, MPH, University of Chicago

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 października 2018

Zakończenie podstawowe (Rzeczywisty)

15 maja 2022

Ukończenie studiów (Rzeczywisty)

30 czerwca 2022

Daty rejestracji na studia

Pierwszy przesłany

21 marca 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 marca 2018

Pierwszy wysłany (Rzeczywisty)

4 kwietnia 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 listopada 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 listopada 2022

Ostatnia weryfikacja

1 listopada 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB17-1385

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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