HOMe-based HEart Failure Self-Management Programme Study (The HOM-HEMP Study): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 1
- 主要终点
- HF self care
研究概览
简要总结
Aim: To develop a nurse-led, home-based self-management psychosocial education programme, entitled HOMe-based HEart Failure Self-Management Programme (HOM-HEMP), and evaluate its effects on improving heart failure self-care, cardiac self-efficacy, health-related quality of life (HRQoL), psychological well-being, perceived social support, and clinical outcomes among patients with heart failure in Singapore.
Background: The number of elderly people is expected to increase in the coming decades, and so too the prevalence of with chronic heart failure (HF) is expected to increase. Since HF is a chronic condition, there is a need to develop programmes that will improve the quality of life of older patients who have to manage this condition for years to come.
Design: A stratified, three-arm randomised controlled trial (RCT) will be adopted.
Methodology:
The HOM-HEMP is designed a six-week home-based psychosocial education programme comprising of a specifically developed HF education and self-management toolkit and three biweekly home visits by the research nurse. In addition, participants in experimental group B will receive a supplementary smartphone app.
A consecutive sample of 213 patients with HF will be recruited from the cardiac ward of a tertiary public hospital in Singapore. They will be randomly assigned to the control group, or experimental group A (HOM-HEMP without App) or the experimental group B (HOM-HEMP with App). A research nurse will be delivering the HOM-HEMP intervention to the participants in the experimental groups, while another research assistant who is blinded to participants' group assignment will be responsible for data collection.
Data will be collected at baseline, at 6 weeks from baseline (i.e. immediate after the intervention), and at 3 and 6 months from the baseline. At the end of the programme, a process evaluation will be conducted to assess the acceptability, strengths and weaknesses of the HOM-HEMP based on the participants' perspectives.
Discussion: It is expected the proposed RCT will make a contribution to knowledge development of the effectiveness of the HOM-HEMP and the active ingredients of the programme.
详细描述
Specific Aims
The primary aims of this study are:
- To develop a nurse-led, home-based self-management psychosocial education programme, entitled HOMe-based HEart Failure Self-Management Programme (HOM-HEMP)
- To examine its effectiveness on improving HF self-care, cardiac self-efficacy, anxiety and depression levels, health-related quality of life (HRQoL), perceived social support, and clinical outcomes among patients with HF in Singapore.
Study Hypotheses
Study participants will be randomised into one of the three groups: a Control Group (receiving usual care), an Experimental Group A (receiving HOM-HEMP without a supplementary smartphone App), and an Experimental Group B (receiving HOM-HEMP with a supplementary smartphone App).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with HF
- •21 years or older, which is the legal age to give consent in Singapore
- •able to comprehend Chinese or English;
- •possess and able to use smart mobile phone (e.g. Samsung Galaxy, iPhone) in their daily lives, and
- •able to be followed up at home after hospital discharge.
排除标准
- •have unstable angina, resting tachycardia (>120 beats/minute), or severe arterial hypertension;
- •have a terminal illness other than HF, e.g. end-stage renal failure, cancer, severe pulmonary disease;
- •have psychiatric or cognitive impairment that will affect patient's understanding of the study intervention and/or nature of the study
- •are bed-bound or wheelchair-bound that will affect patient's ability to perform self-care
- •No internet access at home
研究组 & 干预措施
Intervention group A
a 6-week nurse-led, home-based self-management psychosocial education programme (HOM-HEMP)
干预措施: HOM-HEMP (Behavioral)
Intervention group B
HOM-HEMP with the smartphone app.
干预措施: HOM-HEMP with smartphone app (Behavioral)
control group
Participants will receive the standard care provided by the hospital. It consists of all nursing, medical, and follow-up services as needed.
干预措施: Standard Care (Behavioral)
结局指标
主要结局
HF self care
时间窗: Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline
As measured by the Self-Care Heart Failure Index (SCHFI)
次要结局
- Health-related quality of life (HRQoL)(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Cardiac Self-Efficacy(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Anxiety and depression levels(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Perceived social support(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
研究者
Wang Wenru
Assistant Professor
National University of Singapore