Using the Internet for Self-management and Monitoring Patients With Heart Failure at a Distance
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Functional capacity
研究概览
简要总结
Several studies have indicated that heart failure (HF) clinics facilitating patient self-management and using multi-disciplinary care reduce in hospital bed-days, all-cause and HF-related hospitalizations, all-cause mortality, and improve patient quality of life. Additionally, national and provincial organizations have identified patient-focused homecare initiatives in telehealth as demonstrating great promise for health service. Our pilot study demonstrated the feasibility of the internet based vHFC and supports the investigation of this intervention in patients with HF.
The purpose of our single-blinded randomized trail is to investigate the efficacy of an Internet-based heart failure (HF) clinic (vHFC) in 186 patients living with HF.
Hypotheses
A. Participation in a vHFC emphasizing patient self-management and monitoring will result in improved functional capacity compared to usual care in patients with HF.
B. Participation in a vHFC emphasizing patient self-management and monitoring will result in improved health indices such as, self-management skills, quality of life, levels of B-type natriuretic peptide and healthcare utilization compared to usual care in patients with HF.
Our objectives of the vHFC study is as follows:
- To establish a cohort of 186 patients with HF.
- To determine the benefits of participating in the vHFC over usual care at 12 months with respect to exercise capacity.
- To compare the changes in other risk factors and lifestyle behaviours between the vHFC and usual care patients.
详细描述
Consecutive cardiac in-patients of the University Hospital of Northern BC in Prince George and of St. Paul's Hospital in Vancouver will be screened for the Inclusion/Exclusion Criteria. Those who meet the criteria will undergo the baseline assessment.
The baseline assessment will include collecting information on social demographics, (including age, gender, education level, and socioeconomic data) medical history, 6-minute walk test, self-management and quality of life, fasting blood test, medication use, HF severity classification, blood pressure, and lifestyle (physical activity, smoking status, alcohol consumption). Following baseline assessment, patients will be stratified by sex and randomized to either the vHFC or usual care.
Usual Care Group:
Participants randomized to usual care will be given educational information explaining what HF is, the importance of salt and fluid restriction, a form to log their weight and a list of Internet-based resources.There will be no contact between the study personnel and the usual care participants for the duration of the study, nor will there be any attempt to control for the level of patient care. Participants will return at 12 months for outcome assessment.
Intervention Group:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •daily Internet access
- •able to provide informed consent
- •able to read, write and understand English without difficulty
排除标准
- •have significant co-morbidities that may interfere with effective HF management
- •reside in a nursing home
- •have a disability that precludes walking
- •patients in who it is foreseen will be unlikely to survive for the duration of the study or have scheduled surgical procedures that based on the opinion of their hospital attending physician should be excluded
结局指标
主要结局
Functional capacity
时间窗: 12 months
Assessed by measuring the distance walked during the 6-minute walk test following the guidelines of the American Thoracic Society.
次要结局
- Self-management skills(12 months)
- Medication use(12 months)
- Health care utilization(12 months)
- Quality of life(12 months)
- Blood pressure(12 months)
- Participant adherence to the vHFC(12 months)
- B-type natriuretic peptide(12 months)
- Lifestyle(12 months)
研究者
Scott Lear
Associate Professor
Simon Fraser University