The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure: A Randomised Controlled Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Push-Pull-Hold Program


Participation Criteria
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Eligibility Criteria
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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 Pregnant

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants in the intervention group will receive face-to-face intervention sessions that include interviews, discussions and didactic teaching. | Behavioral: Push-Pull-Hold Program<br>* Developed based on concepts of motivational interviewing, temporal framing, empowerment. It is tailored to Singaporean patients and includes contextual self-care information and tips.<br>* Other names: PPHP;|
| No Intervention: Control group<br>Participants in the control group will receive usual care that normally includes three monthly outpatient doctor consultations and when necessary, heart failure nurse referral. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Self-Care of Heart Failure Index (SCHFI) maintenance subscale | 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. | weeks 1, 12 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Consideration of Future Consequences Scale (CFCS) | CFCS is a 14-items self-administered instrument that measures the degree to which one considers about and is influenced by the potential consequences of their present behaviours. Each item is measured using a 7-point Likert scale where 1 represents extremely uncharacteristic and 7 represents extremely characteristic of the participant. The average scores of the items will be calculated, where a higher score indicates a higher consideration of future consequences. | weeks 1, 12 and 24 | 
| Changes in intention to change behaviours | Intention will be measured using a self-developed 3-item, self-administered instrument. Responses will be measured on a 7-point Likert scale where a higher score indicates a higher intention to change behaviours. | weeks 1, 12 and 24 | 
| Changes in the Self-Report Habit Index (SRHI) | SRHI is a 12-items, self-administered instrument that measures automaticity; behaviour frequency; and self-identity on a 7-point Likert scale. Scores will be averaged and a higher score indicates higher habit strength. | weeks 1, 12 and 24 | 
| Changes in Mindfulness Attention Awareness Scale (MAAS) | MAAS is a 15-items, self-administered instrument measured on a 6-point Likert scale. A mean score will be computed and a higher score indicates higher level of mindfulness. | weeks 1, 12 and 24 | 
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) | MLHFQ is a 21-items, self-administered instrument measured on a 6-point Likert scale and includes components of physical, emotional, social and mental dimensions of quality of life. Scores will be summed up and ahigher score indicates poorer quality of life. | weeks 1, 12 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, self-care, behavio*, intervention, randomized controlled trial