Improving Medication Adherence in Post-ACS Patients
Improving Med Adherence in Post-ACS Patients: Phase 1B Dose-Finding RCT
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
New York
-
New York、New York、美国、10032
- Columbia University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预: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. |
|
实验性的: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.
|
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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Prevalence of medication adherence
大体时间:30 days
|
30 days
|
合作者和调查者
调查人员
- 首席研究员:Karina W. Davidson, PhD、Columbia University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
PST therapy的临床试验
-
University of Illinois at ChicagoNational Institute of Mental Health (NIMH); Washington University School of Medicine; Stanford... 和其他合作者招聘中
-
University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的
-
University of OttawaOttawa Hospital Research Institute撤销
-
University of Texas at AustinBaylor College of Medicine; University of Kansas Medical Center完全的