Training and Supervision Program for Depression Management
Comprehensive Technology-Assisted Training and Supervision Program to Enhance Depression Management in Primary Care
調査の概要
詳細な説明
A cluster randomized controlled clinical trial will be conducted in four Primary Health Care (PHC) clinics in Santiago, Chile.
The sample selection of the PHC clinics will be performed in two steps. Firstly, two urban municipalities of Santiago Metropolitan Region, Chile, will be randomly selected if they work with the Faculty of Medicine of the U.Chile and have at least two PHC.Municipalities with a high Human Development Index, high percentage of immigrants and older population, and Psychiatry residents working in PHC , will be excluded.Secondly in each selected municipalities,two PHC will be randomly selected for the active and control arm.
To detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, 152 depressed persons, 76 to each group, will be required for the study. A design effect of 2.42 was estimated. After applying the design effect the sample needed increased to 368 depressed persons. Considering a retention rate of approximately 85%, 434 depressed cases will be needed required for the study, hence 109 cases in each of the 4 primary health care clinics.
Analysis and presentation of the results will be in accordance with CONSORT guidelines for randomized clinical trials, with the primary comparative analysis being conducted on an intention to treat basis and due emphasis placed on confidence intervals for the between-arm comparisons.
Initially descriptive analysis to assess the balance between two groups will be conducted. The primary analysis will employ multilevel multivariable lineal regression to investigate differences in the PHQ-9 scores between groups at 3 and 6 months after randomization, adjusting for baseline outcome variable scores. Sensitivity analysis making different assumptions will be conducted to investigate the potential effects of missing data. Similar analysis will be done for the secondary outcomes measures.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Santiago
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Quinta Normal、Santiago、チリ
- CESFAM Garín
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Quinta Normal、Santiago、チリ
- CESFAM Lo Franco
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San Miguel、Santiago、チリ
- CESFAM Barros Luco
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San Miguel、Santiago、チリ
- CESFAM Recreo
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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:
- signing written informed consent
- age between 18-65 years
- current depressive episode, according to the Mini-International Neuropsychiatric Interview (MINI)
Exclusion Criteria:
- current depression treatment
- no access to telephone
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Depression training/supervision program
A complex intervention, which will include:
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The intervention will be composed of:
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介入なし：Usual Care
Patients in the control group will receive all the interventions that are guaranteed for persons with depression in Chile: treatment in Primary Health Care clinics with the Primary Health Care team and referral to the regional specialized psychiatric service.
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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 |
|---|---|---|
|
Change from Baseline Depressive Symptomatology at 3 months
時間枠：Baseline , 3 months
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Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 3 months after patient recruitment.
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Baseline , 3 months
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Change from Baseline Depressive Symptomatology at 6 months
時間枠：Baseline, 6 months.
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Depressive symptomatology measured with the Patient Health Questionnaire - Nine Item (PHQ-9) at 6 months after patient recruitment.
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Baseline, 6 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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Adherence to depression treatment at patient's level
時間枠：3 and 6 months after baseline.
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3 and 6 months after baseline.
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Change from Baseline Quality of life at 3 and 6 months
時間枠：Baseline , 3 months, 6 months.
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Quality of life at patient's level measured with the Health Survey, Short form (SF-36), at 3 months and 6 months after patient recruitment.
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Baseline , 3 months, 6 months.
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Change from Baseline Clinical Outcomes at 3 and 6 months
時間枠：Baseline , 3 months, 6 months.
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Clinical outcomes at patient's level measured with the Outcome Questionnaire-45.2 (OQ-45.2),
at 3 months and 6 months after patient recruitment.
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Baseline , 3 months, 6 months.
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Use of Health Care services at patient's level
時間枠：3 and 6 months after baseline
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Use of Health Care services at patient's level measured with and ad-hoc built questionnaire.
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3 and 6 months after baseline
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Rate of treated depressed cases at Primary Care team level
時間枠：12 months before randomization and 12 months after.
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12 months before randomization and 12 months after.
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協力者と研究者
スポンサー
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 (実際)
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 (実際)
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。
Depression training/supervision programの臨床試験
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Children's Hospital Los AngelesRobert Wood Johnson Foundation募集