A Pilot Study to Improve Diabetes Management Through Family-Based Health Care Navigation (HOOKELE)
Visão geral do estudo
Status
Condições
Descrição detalhada
The purpose of this small R01 is to test the feasibility and preliminary efficacy of a family-based DSMES and social care navigation intervention to improve diabetes-related outcomes among NHPI patients with poorly managed diabetes and social needs. KP Hawaii NHPI patients (N = 80) age ≥ 18, recent A1C >8%, and who report >1 social needs will be recruited and randomized to one of two study arms: 1) family-based group centered DSMES and social care navigation intervention; or 2) enhanced usual care. In the family-based intervention, participants and their family members will receive the 6-week NHPI culturally adapted DSMES program that will be delivered by a NHPI pharmacist from the Mauliola Pharmacy. In collaboration with our partners, Hui No Ke Ola Pono, a community-based organization that employs CHWs, enrolled participants and their family members will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months. Participants in the enhanced usual care arm will receive standard diabetes clinical care and be provided with a tailored community-based resource list. Feasibility will be determined using mixed methods and based on recruitment, retention, attendance, social need resolution, and several implementation outcomes. We will also examine intervention preliminary effects on diabetes distress, self-management, self-efficacy/empowerment, A1C, and healthcare utilization at 6 months. We propose the following aims:
Aim 1. Determine feasibility of the family-based group centered DSMES and social care navigation intervention based on: a) recruitment and retention rates; b) session attendance; c) number of participants with social need(s) met, not met, or pending at 6 months; d) acceptability; e) practicality; f) fidelity; and g) cultural appropriateness.
Aim 2. Explore preliminary efficacy by comparing the two study arms on the following outcomes at 6-months post-randomization: a) diabetes distress; b) diabetes self-management; c) diabetes self-efficacy; d) mean change in A1C; e) proportion of participants with a clinic-based A1C test; and f) proportion of patients who attended a scheduled follow-up primary care appointment.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Maile Taualii, PhD, MPH
- Número de telefone: 808-462-1437
- E-mail: maile.m.taualii@kp.org
Estude backup de contato
- Nome: Jonathan Lai
- Número de telefone: 808- 476-1747
- E-mail: jonathan.ws.lai@kp.org
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- age 18 or older;
- identify as Native Hawaiian or Pacific Islander;
- diagnosed with type 2 diabetes;
- most recent A1C ≥ 8%;
- reports ≥ 1 social need;
- receive care at KPHI, and
- have an adult family member who will commit to attending classes with the participant.
Exclusion Criteria: Patients who are not able to provide informed consent due to cognitive impairment
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Family-based group-centered DSMES plus social care navigation intervention
In the family-based group-centered intervention, participants and their family member (who may be food preparers or meal planners such as spouses, parents, or adult children) will participate in an existing 6-week, NHPI culturally adapted DSMES program offered by a NHPI community partner.
Each participant and family unit will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months.
|
In the family-based group-centered intervention, participants and their family member (who may be food preparers or meal planners such as spouses, parents, or adult children) will participate in an existing 6-week, NHPI culturally adapted DSMES program offered by a NHPI community partner.
Each participant and family unit will be assigned a NHPI CHW who will provide navigation support to social services and community-based resources to address social needs for 6 months.
|
|
Comparador Ativo: Enhanced routine care
Participants in the enhanced routine care arm will receive the standard diabetes clinical care at KP Hawaii and be provided with a tailored community-based resource list.
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Participants in the enhanced routine care arm will receive the standard diabetes clinical care at KP Hawaii and be provided with a tailored community-based resource list.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility of the family-based DSMES and social care intervention
Prazo: 6-months follow-up
|
Fidelity
|
6-months follow-up
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Feasibility of the family-based DSMES and social care intervention
Prazo: 6-months follow-up
|
Fidelity
|
6-months follow-up
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maile Taualii, PhD, MPH, Kaiser Permanente
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R01DK142020 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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