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

1 de novembro de 2022 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

265

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • University of Chicago

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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).
Outro: 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.
Outro: 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)).
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
Hemoglobin A1C
Prazo: change from baseline to 12 months
change from baseline to 12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Hemoglobin A1C
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Number of hospital admissions
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Depression (PHQ-2)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Diabetes Self-Empowerment Scale
Prazo: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Diabetes Social Support Scale
Prazo: baseline, 6 month, and 12 month for intervention patients only
baseline, 6 month, and 12 month for intervention patients only
Patient satisfaction with intervention
Prazo: 6 month and 12 month for intervention patients only
6 month and 12 month for intervention patients only
CAHPS Overall Rating
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Patient engagement
Prazo: 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
Prazo: 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
Prazo: post-training (16 month)
Satisfaction with training, group visits, and text messaging
post-training (16 month)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Chicago

Colaboradores

Midwest Clinicians' Network
CareMessage

Investigadores

  • Investigador principal: Arshiya Baig, MD, MPH, University of Chicago

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de outubro de 2018

Conclusão Primária (Real)

15 de maio de 2022

Conclusão do estudo (Real)

30 de junho de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

21 de março de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de março de 2018

Primeira postagem (Real)

4 de abril de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de novembro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de novembro de 2022

Última verificação

1 de novembro de 2022

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IRB17-1385

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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