The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Changes in Self-Care of Heart Failure Index (SCHFI) maintenance subscale
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinically diagnosed with chronic heart failure for at least 1 month
- •More than 21 years old
- •Able to read and understand English or Chinese
Exclusion Criteria
- •Dependent on caregivers
- •Awaiting implantable devices or surgery
Arms & Interventions
Intervention group
Participants in the intervention group will receive face-to-face intervention sessions that include interviews, discussions and didactic teaching.
Intervention: 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.
Outcomes
Primary Outcomes
Changes in Self-Care of Heart Failure Index (SCHFI) maintenance subscale
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Jocelyn Chew
Principal Investigator
Chinese University of Hong Kong