Heart Failure
Conditions
Keywords
heart failure, self-care, behavio*, intervention, randomized controlled trial
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.
Interventions
BEHAVIORALPush-Pull-Hold Program
Developed based on concepts of motivational interviewing, temporal framing, empowerment. It is tailored to Singaporean patients and includes contextual self-care information and tips.
Sponsors
National Heart Centre Singapore
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
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 * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Self-Care of Heart Failure Index (SCHFI) maintenance subscale | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in intention to change behaviours | weeks 1, 12 and 24 | 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. |
| Changes in the Self-Report Habit Index (SRHI) | weeks 1, 12 and 24 | 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. |
| Changes in Mindfulness Attention Awareness Scale (MAAS) | weeks 1, 12 and 24 | 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. |
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) | weeks 1, 12 and 24 | 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. |
| Changes in the Consideration of Future Consequences Scale (CFCS) | weeks 1, 12 and 24 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Week 24 | Incidence of mortality. |
| Changes in emergency department visits | Weeks 1 and 24 | Measures the changes in the incidence of emergency department visits. |
| Changes in readmission | Weeks 1 and 24 | Measures the changes in readmission incidences. |
Countries
Singapore
Outcome results
None listed