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临床试验/NCT01864369
NCT01864369已完成不适用

Canadian e-Platform to Promote Behavioral Self-Management in Chronic Heart Failure: CHF-CePPORT

University Health Network, Toronto3 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
248
试验地点
3
主要终点
Quality of Life: Kansas City Cardiomyopathy Questionnaire

研究概览

简要总结

Chronic Heart Failure (CHF) is a growing public health issue in Canada. Hospital re-admission within 1-year after diagnosis is 25-40%, and the 5-year rate of CHF death is 50%. Counseling by multidisciplinary health care teams helps CHF patients to improve self-care behaviors (for medications, diet, exercise, smoking cessation and symptom monitoring), and this reduces the rate of death and CHF hospitalization. In the absence of intervention, patient adherence to these behaviors is below recommended standards and quality of life among CHF patients becomes progressively compromised. A major challenge is to make self-care counseling available without overtaxing health care resources.

This year multicenter clinical trial will establish and evaluate a Canadian e-platform that provides multidisciplinary e-counseling to help patients with CHF to initiate and maintain recommended self-care behaviors. The investigators will recruit 298 CHF patients in Toronto, Montreal and Vancouver. The investigators hypothesize that a 12-month program of e-Counseling + Usual Care versus general eInfo + Usual Care will improve quality of life, self-care behaviors, program engagement, and heart health. This proposal is based upon previous clinical trials in CHF, e-health and preventive lifestyle counseling by our team. The novel contribution of this research is that it will establish an infrastructure for a pan-Canadian e-platform in preventive e-counseling for CHF. A key feature of this proposal is that our multidisciplinary team will work with professional heart health organizations to share our findings and e-health resources with the public and other health care professionals in Canada, which will help to galvanize research and clinical work in eCounseling. Our clinical trial will strengthen eCounseling services in order to improve the quality of life of patients with CHF.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • •Male and female patients 18 years of age who are diagnosed with heart failure with reduced ejection fraction ("systolic HF") corresponding to New York Heart Association Class II-III for 3 months prior to enrolment;
  • •documentation of LVEF 40%;
  • •subject has access to a personal computer;

排除标准

  • •Documentation at enrolment of renal failure, significant liver disease or poorly controlled diabetes mellitus;
  • •persistent systolic or diastolic hypertension [systolic > 170 mmHg or diastolic > 100 mmHg despite antihypertensive therapy;
  • •CHF secondary to cardiovascular co-morbidities/procedures;
  • •previous heart transplant or wait listed for heart transplant at time of enrolment

研究组 & 干预措施

Control: eInfo + Usual Care

Active Comparator

Usual Care + eInfo on general guidelines for heart healthy living

干预措施: eCounseling + Usual Care (Behavioral)

Behavioral: eCounseling + Usual Care

Experimental

Behavioral:eCounseling + Usual Care: interactive web pages utilized to provide e-counseling messages and e-tools.

干预措施: eCounseling + Usual Care (Behavioral)

结局指标

主要结局

Quality of Life: Kansas City Cardiomyopathy Questionnaire

时间窗: 12 months

The primary outcome in CHF-CePPORT is quality of life, as measured by the number of subjects who demonstrate a clinically meaningful increase of ≥5 points on the summary index of the Kansas City Cardiomyopathy Questionnaire (KCCQ).

次要结局

  • Clinical and functional assesments.(12-months)
  • Behavioral, functional and clinical outcomes(4- and 12- months)
  • Behavioral,functional and clinical outcomes(4- and 12- months)
  • Behavioral, clinical and funcitonal outcomes(4 and 12- months)
  • Program engagement and usability(4- and 12- months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Nolan

Research Psychologist- Director, Behavioral Cardiology Research Unit

University Health Network, Toronto

研究点 (3)

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