Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Peer-Led Self-Management Support in "Real World" Clinical and Community Settings

8. september 2014 opdateret af: Rebecca Mase, University of Michigan
This study will systematically evaluate a training program in state-of-the-art behavioral change approaches and facilitation skills for peer leaders and a peer-led diabetes self-management support program designed to be conducted in community and clinic-based settings on an ongoing basis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In phase one we will develop and evaluate a theoretically-driven program to train peer leaders to facilitate longer-term empowerment-based interventions that, when led by health care professionals, have been associated with improved diabetes-related health and psychosocial outcomes.1-8 In phase two we will examine the impact of a sustained peer-led, empowerment-based self-management intervention on improving and maintaining diabetes-related health outcomes. We propose to develop and test the training and program simultaneously in two distinct cultural and linguistic communities with which the team already has strong working relationships and a track record of prior work: African-American (AA) adults in a community-based setting (Ypsilanti, Michigan) and Latino adults (Spanish- and English-speaking) in a clinic-based setting (Southwest Detroit). This will allow us to compare and contrast the translations of the training and program in these two different contexts and to better refine and understand effective methods and develop culturally tailored training and program materials in both English and Spanish.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

241

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48104
        • University of Michigan

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • the study will recruit African Americans and Latinos with type 2 diabetes, - at least 21 years old, and
  • who have a regular health care provider, and
  • will commit to attend the 12 session DSME program.

Exclusion Criteria:

  • having physical limitations preventing participation, and
  • other serious health conditions (e.g., terminal cancer),
  • serious psychiatric illness, self-reported excessive alcohol or illicit drug use, and
  • serious diabetes complications (e.g., blindness) that would impede meaningful participation in the program

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention: Peer Led Self-Management
Intervention: Peer Led Self-Management (PLSM) involves the DSME program followed by 12 months of peer-led ongoing self-management support
Adfærdsmæssigt: Peer-Led Self-Management

The PLSM intervention is designed to improve and sustain participants' self-management and health-related gains associated with type 2 diabetes. The role of peer leaders is to provide support for (1) ongoing self-management efforts (including the 5-step "action-planning" process), (2) psychosocial and emotional adjustment, and (3) linkage to needed health care resources.

PLSM intervention will consist of three main components provided by the Peer Leaders: weekly self-management support sessions; outreach telephone contacts and inbound telephone call from participants.

Andre navne:
  • Peer Support
  • Peer Leadership
Ingen indgriben: Diabetes Self-Management Education
Control: Diabetes Self-Management Education (DSME) involves 12 sessions of self-management training including diabetes education, one-on-one sessions, bi-weekly phone contacts, and preparation for a clinic visit.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in clinical, self-care and diabetes-related quality of life from baseline
Tidsramme: Measured at completion of 12 session DSME program, DSME program completion occurs between 3 and 6 months following enrollment; 6 months post-completion; 12 months post-completion
Clinical, self-care and diabetes-related quality of life improvements including the following measures: A1c, Summary of Diabetes Self-Care Activities Measure, Diabetes Distress Scale (DDS)
Measured at completion of 12 session DSME program, DSME program completion occurs between 3 and 6 months following enrollment; 6 months post-completion; 12 months post-completion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in clinical, self-care and diabetes-related quality of life from baseline
Tidsramme: Measured at completion of 12 session DSME program, DSME program completion occurs between 3 and 6 months following enrollment; 6 months post-completion; 12 months post completion
Clinical, self-care and diabetes-related quality of life improvements including the following measures: lipid levels, blood pressure reading, height and weight, BMI, and satisfaction with care.
Measured at completion of 12 session DSME program, DSME program completion occurs between 3 and 6 months following enrollment; 6 months post-completion; 12 months post completion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Michigan

Samarbejdspartnere

American Academy of Family Physicians

Efterforskere

  • Ledende efterforsker: Michele Heisler, MD, MPA, University of Michigan

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2010

Primær færdiggørelse (Faktiske)

1. december 2013

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

17. januar 2012

Først indsendt, der opfyldte QC-kriterier

20. januar 2012

Først opslået (Skøn)

25. januar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2014

Sidst verificeret

1. september 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • DRDA 90-0893

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner