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Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes (PLEASED)

1 de novembro de 2016 atualizado por: University of British Columbia

Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes: A Randomized Controlled Trial (The PLEASED Trial)

PLEASED is a 12-month program that aims to help South Asians with type 2 diabetes improve and sustain diabetes-related health outcomes e.g. glycemic control, quality of life...) achieved from previous short-term diabetes education program. Our goal is to provide a new generation of education and support that can be ongoing, patient-driven, and flexible to the dynamic and evolving conditions of patients' "real-word" environment and life circumstances.

Visão geral do estudo

Status

Desconhecido

Condições

Intervenção / Tratamento

Descrição detalhada

Diabetes self-management education: In the first three months of PLEASED, patients with type 2 diabetes will participate in 12 weekly sessions: 6 sessions will focus on diabetes education and be delivered by a health professional and 6 sessions will focus on lifestyle change and be delivered by a peer leader. Education sessions will be 2-hours long and be facilitated by nurses, dieticians, and pharmacists. Patients will learn about the diabetes disease process, lifestyle modification, healthy eating, physical activity, medications, monitoring, short- and long- complications, diabetes distress, and coping. Lifestyle change sessions will be 1-hour long and start with 30 minutes of physical activity followed by 30 minutes of goal-setting, action planning, and problem solving. Additional activities such as recipe makeovers and exchanges will also be included.

Diabetes self-management support: In the next nine months of the PLEASED program, patients will be invited to attend 32 weekly self-management support sessions (1-hour long) facilitated by a peer leader. The goal of these sessions is to help patients continue making positive lifestyle changes. Each support session will start with 30 minutes of physical activity led by the peer leader followed by a discussion where participants are invited to (1) discuss self-management challenges, (2) share thoughts and feelings about these challenges, (3) ask self-management questions, (4) engage in problem solving, and (5) set self-management goals and design behavioral experiments to achieve those goals. Patients are invited to attend as frequently as they need or as they are able to given other competing life demands. While these sessions focus on lifestyle change and emotional support, participants will be able to obtain responses to medical and clinical questions from 811 or the PLEASED hotline (hosted by dieticians, nurses, and pharmacists).

All patients enrolled in the PLEASED program will undergo three free health assessments: at the start of the program, at 3 months, and at 12 months. Health assessments will include measuring glycemic control, ApoB, blood pressure, waist circumference, weight, and body mass index. All patients will also complete a survey assessing quality of life, social support, depression, and self-efficacy.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

80

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

  • Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá, V6Z 1Y6
        • St. Paul's Hospital

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

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

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

To be eligible to participate as a subject in this study, individuals must

  1. Have type 2 diabetes,
  2. Be of South Asian background,
  3. Live in the Metro Vancouver area,
  4. Be at least 21 years old,
  5. Have transportation to attend group sessions.

To be eligible to participate as a peer leader in this study, individuals must

  1. Have diabetes or are a caregiver to someone who has diabetes,
  2. Are of South Asian background,
  3. Live in the Greater Vancouver area,
  4. Are at least 21 years old,
  5. Are bilingual in English and Punjabi,
  6. Have transportation to attend training,
  7. Are able and willing to commit to 6 sessions of training (5 hours each, over a 6 week period)

Exclusion criteria for both participants and peer leaders include:

  1. Serious health conditions
  2. Addictions to alcohol or drugs, which would hinder meaningful participation in the study.

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: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Peer Support
Peer support intervention group: During the first 3 months of DSME, participants in the DSMS intervention group will be invited to attend 6 lifestyle change sessions delivered a 2-person peer leader team and conducted bi-weekly. Immediately following the 3 months of DSME, participants are invited to attend 9 months of weekly DSMS sessions (60-minutes per session) delivered by a Peer Leader. These sessions are designed to sustain the self-management gains achieved in the 3 months of DSME.
Comportamental: Peer Support
The intervention is lifestyle change. First, the peer leaders will be trained how to conduct diabetes self-management education and support sessions. During the first 3 months, all the participants will attend the diabetes self-management education sessions. The participants in the intervention arm will also receive diabetes self-management support sessions as well. In the end of the first 3 months, the intervention group participants will receive weekly support sessions for 9 months.
Sem intervenção: Wait-list Control
Immediately following the 6 bi-weekly DSME sessions, participants randomized to the Wait-list control group will have completed their participation in the study.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Glycemic Control measured by HbA1c
Prazo: Up to 12 months
To compare a peer support model for diabetes self-management support (DSMS) to usual care on sustaining improvements in glycemic control achieved from short-term diabetes self-management education (DSME).
Up to 12 months

Medidas de resultados secundários

Medida de resultado
Prazo
Blood pressure (mmHg) measured by Omron BP785 monitor
Prazo: Up to 12 months
Up to 12 months
ApoB (g/L) will be collected using venous puncture blood draw
Prazo: Up to 12 months
Up to 12 months
Waist circumference (inch) measured by Seca 203 Circumference Measuring Tape
Prazo: Up to 12 months
Up to 12 months
Body Mass Index (kg/m2)
Prazo: Up to 12 months
Up to 12 months
Physical activity measured by the actical accelerometer
Prazo: Up to 12 months
Up to 12 months
Diabetes-specific Social Support will be assessed using a 4-item perceived social support scale developed by Tang et al. that measures amount of support and satisfaction with support from family, friends and the health care team
Prazo: Up to 12 months
Up to 12 months
Depressive Symptom Severity will be assessed with the PRIME-MD Patient Health Questionnaire (PHQ-9)
Prazo: Up to 12 months
Up to 12 months
Diabetes-related distress measured by the Diabetes Distress Scale (DDS), a 17-item scale developed by Polonsky and colleagues
Prazo: Up to 12 months
Up to 12 months
Height measured using a stadiometer
Prazo: Up to 12 months
Up to 12 months
Weight measured on a high quality, calibrated digital scale, with the participant wearing clothes, but no shoes
Prazo: Up to 12 months
Up to 12 months

Colaboradores e Investigadores

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

Patrocinador

University of British Columbia

Colaboradores

VGH and UBC Hospital Foundation

Investigadores

  • Investigador principal: Tricia Tang, PhD, University of British Columbia

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

1 de novembro de 2013

Conclusão Primária (Antecipado)

1 de setembro de 2017

Conclusão do estudo (Antecipado)

1 de setembro de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

24 de fevereiro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de janeiro de 2016

Primeira postagem (Estimativa)

22 de janeiro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

3 de novembro de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de novembro de 2016

Última verificação

1 de novembro de 2016

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • H13-02163-A002

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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