Improving Medication Adherence in Post-ACS Patients
Improving Med Adherence in Post-ACS Patients: Phase 1B Dose-Finding RCT
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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New York
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New York、New York、アメリカ、10032
- Columbia University
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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:
Medical eligibility:
- Patient presenting for staged intervention with positive cardiac history OR
- Patient with stable CAD who received cardiac admission but does not report chest pain. OR
- Patient with stable CAD who has had a cardiac admission in the past.
- Patient is non-adherent to prescribed medication.
The following exclusion criteria have been set for either safety concerns or concerns that patients will not be able to complete the protocol:
- inability to communicate in English or Spanish
- unwilling to be randomized or to have aspirin in a separate bottle if they use a pill box
- unavailability for the 1 month period of the study (including being unavailable by phone and/or traveling out of the country)
- medically unable to receive aspirin (e.g. allergy, contra-indicated, etc)
- deemed unable to comply with the protocol (either self selected or by indicating during screening that s/he could not complete all requested tasks). This includes patients with a level of cognitive impairment indicative of dementia, and patients with current alcohol or substance abuse.
- deemed to need immediate psychiatric assessment (e.g., must be hospitalized, or have some other psychiatric intervention conducted within 72 hours).
- active psychosis, bipolar disorder, or any overt personality disorder
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:支持療法
- 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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介入なし:A
Participants will complete Baseline and 30-day assessment visit. At both visits BDI II, Self-Efficacy Questions, AEs Assessment, and Treatment Satisfaction will be assessed. A MEMS cap will be used during the 30-day period to asses medication adherence to their prescribed aspirin. Usual Care: Participants assigned to UCC will only receive the pre- and post-assessment session, and any adherence education or encouragement that is regularly provided by their treating physicians. |
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実験的:B
Participants will complete Baseline and 30-day assessment visit.
At both visits BDI II, Self-Efficacy Questions, AEs Assessment, and Treatment Satisfaction will be assessed.
A MEMS cap will be used during the 30-day period to asses medication adherence to their prescribed aspirin.
After Baseline, there is an initial session telephone session with PST therapist.
Subsequent treatment sessions provide a context for the patient to discuss the problems and difficulties they face and that give rise to medication non-adherence.
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Problem-Solving Therapy (PST) is a behavioral approach that teaches patients how to systematically solve their own behavioral difficulties.
During telephone treatment sessions, the patient will discuss the problems and difficulties they face and that give rise to medication non-adherence.
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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 |
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Prevalence of medication adherence
時間枠:30 days
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30 days
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Karina W. Davidson, PhD、Columbia University
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。
PST therapyの臨床試験
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University of OttawaOttawa Hospital Research Institute引きこもった
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Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
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University of Illinois at ChicagoNational Institute of Mental Health (NIMH); Washington University School of Medicine; Stanford... と他の協力者募集
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Universitätsklinikum Hamburg-Eppendorf完了
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Thomas Jefferson UniversityJohns Hopkins University; Dartmouth-Hitchcock Medical Center完了