NCT01814696终止不适用
The Effect of the MedSentry System on Medication Adherence for Patients With Congestive Heart Failure: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Medical Outcomes Study (MOS) "Adhere"
研究概览
简要总结
The goal of this pilot study to evaluate the effect of the MedSentry system, a multi-faceted medication adherence device and reminder system, on medication adherence and clinical outcomes in heart-failure (HF) patients. We will also evaluate the usability and satisfaction derived from using this system.
We hypothesize that:
- The use of the MedSentry system will improve medication adherence in patients with a discharge diagnosis of HF.
- The improvement in adherence correlates with fewer hospitalizations and emergency department (ED) visits.
- The improvement in adherence correlates with better health-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have successfully completed the Partners Connected Cardiac Care Program (CCCP)
- •Take at least 3 and no more than 10 different daily medications (including both prescription and non-prescription/over the counter medications) to treat Heart Failure (HF) and other comorbid disorders.
- •Take medications no more than 4 specified times each day (i.e. morning, afternoon, early evening, bedtime).
- •The patient must be able to open a pill bottle independently.
- •The patient must be able to sort and manage their own medications.
- •Hospitalization within the last 24 months.
- •Have a telephone or cell phone.
- •Live in the greater Boston area.
- •The patients must speak, read and write English.
- •The patients must not be either vision or hearing impaired (i.e., unable to hear an alarm similar to a clock alarm or oven alarm).
- •Patient must have an Massachusetts General Hospital (MGH) affiliated care provider.
排除标准
- •Dementia or other conditions precluding the participant from providing informed consent or from learning to use the MedSentry pillbox.
- •Home environment unsuitable for the MedSentry pillbox and other installed equipment.
- •Awaiting revascularization, cardiac resynchronization or heart transplant.
- •Patients with a coexisting terminal illness like cancer or Chronic Renal Failure (CRF) requiring dialysis.
结局指标
主要结局
Medical Outcomes Study (MOS) "Adhere"
时间窗: 3 months
Subject reported medication adherence. The Medical Outcomes Study (MOS) "Adhere" medication adherence measure consists of a single question that asks participants "How often did you take your medications as prescribed during the past 4 weeks?" Responses are recoded into a dichotomous measure of nonadherent (none, a little, some of the time) and adherent (most, all of the time).
次要结局
- Number of Hospitalization Visits.(3 months)
- Hospitalization, Length of Stay (Days)(3 months)
- Number of Participants With 1 or More Emergency Department (ED) Visits.(3 months)
- Number of Emergency Department (ED) Visits.(3 months)
- Number of Participants With 1 or More Hospitalizations.(3 months)
- Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score(Baseline, end 3 months)
研究者
Joseph C. Kvedar
Dermatologist
Massachusetts General Hospital
研究点 (2)
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