ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama (ENCOURAGE)
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: 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.
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Experimentell: 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. |
This intervention tested the effects of a peer coaching program plus brief diabetes education versus brief diabetes education alone on diabetes outcomes.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Glycated hemoglobin (A1c)
Tidsram: Change in A1c in 12 months
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fingerstick, point-of-care a1c test
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Change in A1c in 12 months
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Blood pressure
Tidsram: Change in blood pressure measure in 12 months
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Measured using digital automated blood pressure monitor
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Change in blood pressure measure in 12 months
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LDL cholesterol
Tidsram: Change in LDL cholesterol in 12 month
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measured using finger stick, spectrophotometer to measure LDL cholesterol
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Change in LDL cholesterol in 12 month
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diabetes self-care behaviors questionnaire
Tidsram: Change in diabetes self-care behaviors at 12 months
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aspects of diabetes self-management such as taking medications as directed, self-report of exercise, and eating behaviors
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Change in diabetes self-care behaviors at 12 months
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depressive symptoms
Tidsram: change in depressive symptoms at 12 months
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self-report using Patient Health Questionnaire 8 (PHQ8)
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change in depressive symptoms at 12 months
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quality of life
Tidsram: Change in quality of life measures at 12 months
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self-report using Short form-1 (SF1), and Euroquol (EQ-5D)
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Change in quality of life measures at 12 months
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patient activation
Tidsram: change in patient activation in 12 months
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self-report using the 13 item Patient Activation Measure (PAM13)
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change in patient activation in 12 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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body mass index
Tidsram: change in BMI in 12 months
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weight measured using digital scale, height measured using stadiometer
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change in BMI in 12 months
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diabetes knowledge
Tidsram: change in diabetes knowledge in 12 months
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assessed using the Spoken Knowledge in Low Literacy in Diabetes Scale
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change in diabetes knowledge in 12 months
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trust in physicians
Tidsram: change in trust in physicians in 12 months
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assessed using the Trust in Physicians Scale
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change in trust in physicians in 12 months
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composite measure of healthcare utilization
Tidsram: Change in health care utilization in 12 months
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self-report by participant, number of times utilized healthcare services
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Change in health care utilization in 12 months
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Samarbetspartners och utredare
Samarbetspartners
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- T0808270039
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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