ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama (ENCOURAGE)
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Glycated hemoglobin (A1c)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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body mass index
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
진성 당뇨병에 대한 임상 시험
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Fondazione Policlinico Universitario Agostino Gemelli...아직 모집하지 않음비만 | 제2형 당뇨병 | 인슐린 저항성 당뇨병 (Mellitus)
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