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

1 november 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Glycemic Control measured by HbA1c
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of British Columbia

Medewerkers

VGH and UBC Hospital Foundation

Onderzoekers

  • Hoofdonderzoeker: Tricia Tang, PhD, University of British Columbia

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2013

Primaire voltooiing (Verwacht)

1 september 2017

Studie voltooiing (Verwacht)

1 september 2017

Studieregistratiedata

Eerst ingediend

24 februari 2015

Eerst ingediend dat voldeed aan de QC-criteria

20 januari 2016

Eerst geplaatst (Schatting)

22 januari 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

3 november 2016

Laatste update ingediend die voldeed aan QC-criteria

1 november 2016

Laatst geverifieerd

1 november 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • H13-02163-A002

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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