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

1 de noviembre de 2016 actualizado 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.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Anticipado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Conductual: 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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Glycemic Control measured by HbA1c
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Periodo de tiempo
Blood pressure (mmHg) measured by Omron BP785 monitor
Periodo de tiempo: Up to 12 months
Up to 12 months
ApoB (g/L) will be collected using venous puncture blood draw
Periodo de tiempo: Up to 12 months
Up to 12 months
Waist circumference (inch) measured by Seca 203 Circumference Measuring Tape
Periodo de tiempo: Up to 12 months
Up to 12 months
Body Mass Index (kg/m2)
Periodo de tiempo: Up to 12 months
Up to 12 months
Physical activity measured by the actical accelerometer
Periodo de tiempo: 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
Periodo de tiempo: Up to 12 months
Up to 12 months
Depressive Symptom Severity will be assessed with the PRIME-MD Patient Health Questionnaire (PHQ-9)
Periodo de tiempo: 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
Periodo de tiempo: Up to 12 months
Up to 12 months
Height measured using a stadiometer
Periodo de tiempo: 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
Periodo de tiempo: Up to 12 months
Up to 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of British Columbia

Colaboradores

VGH and UBC Hospital Foundation

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de noviembre de 2013

Finalización primaria (Anticipado)

1 de septiembre de 2017

Finalización del estudio (Anticipado)

1 de septiembre de 2017

Fechas de registro del estudio

Enviado por primera vez

24 de febrero de 2015

Primero enviado que cumplió con los criterios de control de calidad

20 de enero de 2016

Publicado por primera vez (Estimar)

22 de enero de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

3 de noviembre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

1 de noviembre de 2016

Última verificación

1 de noviembre de 2016

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • H13-02163-A002

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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