- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03487692
Medical Care, Education, Social Support, And Goal-setting to Empower Self-management for Diabetes (MESSAGES)
1 novembre 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
265
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Illinois
-
Chicago, Illinois, États-Unis, 60637
- University of Chicago
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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).
|
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.
|
Autre: 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)).
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Hemoglobin A1C
Délai: change from baseline to 12 months
|
change from baseline to 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hemoglobin A1C
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: baseline, 6 month, and 12 month for intervention patients only
|
baseline, 6 month, and 12 month for intervention patients only
|
|
Number of hospital admissions
Délai: 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
Délai: 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
Délai: 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)
Délai: baseline, 6 month, and 12 month for intervention patients only
|
baseline, 6 month, and 12 month for intervention patients only
|
|
Depression (PHQ-2)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: baseline, 6 month, and 12 month for intervention patients only
|
baseline, 6 month, and 12 month for intervention patients only
|
|
Diabetes Self-Empowerment Scale
Délai: baseline, 6 month, and 12 month for intervention patients only
|
baseline, 6 month, and 12 month for intervention patients only
|
|
Diabetes Social Support Scale
Délai: baseline, 6 month, and 12 month for intervention patients only
|
baseline, 6 month, and 12 month for intervention patients only
|
|
Patient satisfaction with intervention
Délai: 6 month and 12 month for intervention patients only
|
6 month and 12 month for intervention patients only
|
|
CAHPS Overall Rating
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Patient engagement
Délai: 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
Délai: 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
Délai: post-training (16 month)
|
Satisfaction with training, group visits, and text messaging
|
post-training (16 month)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Arshiya Baig, MD, MPH, University of Chicago
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 octobre 2018
Achèvement primaire (Réel)
15 mai 2022
Achèvement de l'étude (Réel)
30 juin 2022
Dates d'inscription aux études
Première soumission
21 mars 2018
Première soumission répondant aux critères de contrôle qualité
27 mars 2018
Première publication (Réel)
4 avril 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 novembre 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 novembre 2022
Dernière vérification
1 novembre 2022
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB17-1385
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Diabète sucré de type 2
-
Bnai Zion Medical CenterInconnue
-
Jiangsu HengRui Medicine Co., Ltd.Complété
-
HighTide Biopharma Pty LtdRecrutement
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Pas encore de recrutement
-
Endogenex, Inc.Pas encore de recrutementDiabète sucré, Type 2 | Diabète | Diabète sucré de type 2 | Diabète de type 2 | Diabète de type 2
-
Jeil Pharmaceutical Co., Ltd.Pas encore de recrutementDiabète sucré de type 2Corée, République de
-
Nanjing First Hospital, Nanjing Medical UniversityRecrutement
-
Nanjing First Hospital, Nanjing Medical UniversityRecrutement
-
Xiangya Hospital of Central South UniversityRecrutement
-
Sun Yat-sen UniversityGuangdong Provincial Hospital of Traditional Chinese Medicine; The Third Affiliated... et autres collaborateursRecrutement
Essais cliniques sur Diabetes MESSAGES Program
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)Complété
-
Akdeniz UniversityPas encore de recrutementAVC ischémique | EncadrementTurquie
-
Johns Hopkins UniversityThe Rita and Alex Hillman Foundation; Abell Foundation; Richman Foundation; Sherman... et autres collaborateursRecrutementParentalité | Intervention parentaleÉtats-Unis
-
University of Texas Rio Grande ValleyHealth and Human Services Commission (HHSC); Pharr-San Juan-Alamo Independent... et autres collaborateursActif, ne recrute pasComportement lié à la santéÉtats-Unis
-
Children's HealthActif, ne recrute pasTroubles du spectre autistiqueÉtats-Unis
-
The University of Hong KongSydney Children's Hospitals Network; SAHKRecrutementTroubles du spectre autistiqueHong Kong
-
Hospices Civils de LyonRésilié
-
Microclinic InternationalRoyal Health Awareness Society (RHAS); Jordanian Ministry of Health (MoH)ComplétéHyperglycémie | Hypertension | Obésité | Diabète sucré, Type 2 | Diabète sucré | Diabète | Poids | Perte de poids | Pression artérielle | Gain de poids | Comportement social | Poids, Corps | Glycémie, hypertension | Mode de vie, Sain | Changement de poids, Corps | Comportement, Santé | Réduction des risques liés au mode... et d'autres conditionsJordan
-
Lady Davis InstituteComplétéSclérodermie systémiqueCanada
-
Bispebjerg HospitalAarhus University Hospital Skejby; Rigshospitalet, Denmark; Danish Cancer SocietyComplétéCancer | Arrêt du tabac | Tabagisme