The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Changes in Self-Care of Heart Failure Index (SCHFI) maintenance subscale
研究概览
简要总结
This study is a randomized controlled trial that tests the effectiveness of a novel intervention called the Push-Pull-Hold program on improving self-care in patients with heart failure. This intervention was developed based on our previous quantitative and qualitative findings and existing psychological concepts. Results would inform current understanding of the intention-behavior link in self-care and inform future policy and intervention development to improve patient and caregiver outcomes.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with chronic heart failure for at least 1 month
- •More than 21 years old
- •Able to read and understand English or Chinese
排除标准
- •Dependent on caregivers
- •Awaiting implantable devices or surgery
研究组 & 干预措施
Intervention group
Participants in the intervention group will receive face-to-face intervention sessions that include interviews, discussions and didactic teaching.
干预措施: Push-Pull-Hold Program (Behavioral)
Control group
Participants in the control group will receive usual care that normally includes three monthly outpatient doctor consultations and when necessary, heart failure nurse referral.
结局指标
主要结局
Changes in Self-Care of Heart Failure Index (SCHFI) maintenance subscale
时间窗: weeks 1, 12 and 24
SCHFI maintenance subscale is a 10-item, self-administered instrument that measures self-care maintenance behaviours such as medication adherence. Each item of the instrument is rated on a 4-point Likert scale and each subscale score is rescaled to range from 0 to 100 where a score of more than or equal to 70 represents adequate self-care.
次要结局
- Changes in intention to change behaviours(weeks 1, 12 and 24)
- Changes in the Self-Report Habit Index (SRHI)(weeks 1, 12 and 24)
- Changes in Mindfulness Attention Awareness Scale (MAAS)(weeks 1, 12 and 24)
- Minnesota Living with Heart Failure Questionnaire (MLHFQ)(weeks 1, 12 and 24)
- Changes in the Consideration of Future Consequences Scale (CFCS)(weeks 1, 12 and 24)
研究者
Jocelyn Chew
Principal Investigator
Chinese University of Hong Kong