Developing Accessible mHealth Programs for Depression Management in Bolivia
調査の概要
詳細な説明
All patients will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 12 weeks. During enrollment, the research team will explain how to use the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, symptoms of depression, and medication adherence (if patients are prescribed an anti-depressant). Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. At the end of each automated call, patients will hear the phone number of their clinic, which they can call for a health problem or to disenroll from the program. At the time of recruitment, if possible, an initial automated call will be sent to the patient's phone so that they can learn what to expect and have the chance to ask questions of the research associate who will be present.
In the event that the patient reports a health or self-care problem during their call (i.e., the patient reports rarely or never taking their medication), a report will automatically be generated and sent by email to the research team plus the patient's designated clinician so that follow-up can take place. The secure email address will be verified with each clinician, and be password protected.
The intervention will last up to 12 weeks, after which the patient will have a follow-up meeting with the research team and will complete a survey about the program. All follow-ups will take place either in person or over the phone.
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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La Paz、ボリビア
- El Servicio Departmental de Salud (SEDES) affiliated clinics
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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:
- 21-80 years of age
- PHQ-8 score of 10 or higher
Exclusion Criteria:
- Have diagnoses indicating a six-month life expectancy
- Prior inpatient psychiatric treatment
- Patients with probable bipolar disorder or cognitive impairment as indicated on validated screeners
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:なし
- 介入モデル:単一グループの割り当て
- 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 |
---|---|
実験的:Automated phone calls
Automated disease assessment & self-care support phone calls for up to 12 weeks.
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Automated disease assessment & self-care support phone calls for up to 12 weeks.
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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 |
時間枠 |
---|---|
Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)
時間枠:Baseline and 12 week post-intervention follow-up
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Baseline and 12 week post-intervention follow-up
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)
時間枠:Baseline and 12 week post-intervention follow-up
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Baseline and 12 week post-intervention follow-up
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Evaluate program feasibility (telephone call completion rates)
時間枠:12 week post-intervention follow-up
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12 week post-intervention follow-up
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Patient satisfaction (satisfaction questionnaire)
時間枠:12 week Post-intervention follow-up
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12 week Post-intervention follow-up
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Patient qualitative feedback (qualitative questionnaire)
時間枠:12 week Post-intervention follow-up
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12 week Post-intervention follow-up
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協力者と研究者
スポンサー
捜査官
- 主任研究者:John D Piette, PhD、University of Michigan
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。