ENCOURAGE: Evaluating Community Peer Advisors and Diabetes Outcomes in Rural Alabama (ENCOURAGE)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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介入なし：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Glycated hemoglobin (A1c)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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body mass index
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
ENCOURAGE Studyの臨床試験
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Digisight Technologies, Inc.わからない