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ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama (ENCOURAGE)

9. marts 2016 opdateret af: Monika M. Safford, Weill Medical College of Cornell University
It is unclear whether peer coaching is effective in minority populations living with diabetes in hard-to-reach, under resourced areas such as the rural South. We examined the effect of an innovative peer coaching intervention plus brief education vs. brief education alone on diabetes outcomes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this project was to provide robust evidence on the effectiveness of a peer support intervention in improving diabetes outcomes by conducting a group-randomized, controlled implementation trial of a volunteer peer support intervention.

The study had three specific aims:

Aim 1. In Phase I (months 0-8), to perform a qualitative needs assessment with peer advisors and health care providers to inform peer advisor roles and responsibilities (i.e., the intervention) and peer advisor recruitment strategies, curriculum and training; and patient recruitment plans.

Aim 2. Also in Phase I, to pilot our collaboratively developed intervention and, based on pilot test results, to recruit and train peer advisors for the intervention, and begin patient recruitment.

Aim 3. In Phase II (months 9-32), conduct the group randomized implementation trial and evaluate it using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

424

Fase

  • Ikke anvendelig

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

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 19 or older in age, diagnosed with diabetes, under the care of a doctor

Exclusion Criteria:

  • not community dwelling, less than 19 years old, pregnant, end-stage medical conditions with limited life expectancy, no access to telephone, does not speak english

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: control group
Participants received 1-hour group diabetes education class covering diabetes basics, healthy eating, stress reduction, physical activity, social support, and how to get the most out of their doctors visit. Participants also received a diabetes report card showing their Hba1c, blood pressure, ldl cholesterol, and body weight.
Eksperimentel: Encourage study

Participants in the intervention arm were paired with a peer coach, interacting by telephone weekly for the first 8 weeks and then monthly for a total of 10 months.

Participants also received 1-hour group diabetes education class covering diabetes basics, healthy eating, stress reduction, physical activity, social support, and how to get the most out of their doctors visit. Participants also received a diabetes report card showing their Hba1c, blood pressure, ldl cholesterol, and body weight.
Adfærdsmæssigt: ENCOURAGE Study
This intervention tested the effects of a peer coaching program plus brief diabetes education versus brief diabetes education alone on diabetes outcomes.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Glycated hemoglobin (A1c)
Tidsramme: Change in A1c in 12 months
fingerstick, point-of-care a1c test
Change in A1c in 12 months
Blood pressure
Tidsramme: Change in blood pressure measure in 12 months
Measured using digital automated blood pressure monitor
Change in blood pressure measure in 12 months
LDL cholesterol
Tidsramme: Change in LDL cholesterol in 12 month
measured using finger stick, spectrophotometer to measure LDL cholesterol
Change in LDL cholesterol in 12 month
diabetes self-care behaviors questionnaire
Tidsramme: Change in diabetes self-care behaviors at 12 months
aspects of diabetes self-management such as taking medications as directed, self-report of exercise, and eating behaviors
Change in diabetes self-care behaviors at 12 months
depressive symptoms
Tidsramme: change in depressive symptoms at 12 months
self-report using Patient Health Questionnaire 8 (PHQ8)
change in depressive symptoms at 12 months
quality of life
Tidsramme: Change in quality of life measures at 12 months
self-report using Short form-1 (SF1), and Euroquol (EQ-5D)
Change in quality of life measures at 12 months
patient activation
Tidsramme: change in patient activation in 12 months
self-report using the 13 item Patient Activation Measure (PAM13)
change in patient activation in 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
body mass index
Tidsramme: change in BMI in 12 months
weight measured using digital scale, height measured using stadiometer
change in BMI in 12 months
diabetes knowledge
Tidsramme: change in diabetes knowledge in 12 months
assessed using the Spoken Knowledge in Low Literacy in Diabetes Scale
change in diabetes knowledge in 12 months
trust in physicians
Tidsramme: change in trust in physicians in 12 months
assessed using the Trust in Physicians Scale
change in trust in physicians in 12 months
composite measure of healthcare utilization
Tidsramme: Change in health care utilization in 12 months
self-report by participant, number of times utilized healthcare services
Change in health care utilization in 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Weill Medical College of Cornell University

Samarbejdspartnere

University of Alabama at Birmingham

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. februar 2009

Primær færdiggørelse (Faktiske)

1. februar 2012

Studieafslutning (Faktiske)

1. februar 2012

Datoer for studieregistrering

Først indsendt

29. maj 2015

Først indsendt, der opfyldte QC-kriterier

1. juni 2015

Først opslået (Skøn)

2. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • T0808270039

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Data will stay at UAB

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 .

Kliniske forsøg med Diabetes mellitus

Kliniske forsøg med ENCOURAGE Study

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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