The Effect of the MedSentry System on Medication Adherence for Patients With Congestive Heart Failure: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 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.
研究组 & 干预措施
Control
Subjects will continue to receive usual medical care from their doctor(s).
MedSentry System
Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
干预措施: MedSentry System (Device)
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 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)
- Number of Hospitalization Visits.(3 months)
- Hospitalization, Length of Stay (Days)(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