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| ID | Type | Description | Link |
|---|---|---|---|
| NTEC-2018-0265 | Other Identifier | The Joint CUHK-NTEC CREC |
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| Name | Class |
|---|---|
| National Heart Centre Singapore | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants in the intervention group will receive face-to-face intervention sessions that include interviews, discussions and didactic teaching. |
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| Control group | No Intervention | Participants in the control group will receive usual care that normally includes three monthly outpatient doctor consultations and when necessary, heart failure nurse referral. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Push-Pull-Hold Program | Behavioral | Developed based on concepts of motivational interviewing, temporal framing, empowerment. It is tailored to Singaporean patients and includes contextual self-care information and tips. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in readmission | Measures the changes in readmission incidences. | Weeks 1 and 24 |
| Changes in emergency department visits | Measures the changes in the incidence of emergency department visits. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jocelyn H.S. Chew, BSc(Nursing) | The Nethersole School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Heart Centre Singapore | Singapore | 678948 | Singapore |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C047254 | 5-phenylpent-4-enyl-1-hydroperoxide |
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| 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 |
| Weeks 1 and 24 |
| Mortality | Incidence of mortality. | Week 24 |