The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure (PPHP)
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|ClinicalTrials.gov Identifier: NCT03612765|
Recruitment Status : Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Behavioral: Push-Pull-Hold Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure: A Randomised Controlled Trial|
|Estimated Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Intervention group
Participants in the intervention group will receive face-to-face intervention sessions that include interviews, discussions and didactic teaching.
Behavioral: Push-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.
Other Name: PPHP
No Intervention: 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.
- 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.
- Changes in the Consideration of Future Consequences Scale (CFCS) [ Time Frame: 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.
- Changes in intention to change behaviours [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 readmission [ Time Frame: Weeks 1 and 24 ]Measures the changes in readmission incidences.
- Changes in emergency department visits [ Time Frame: Weeks 1 and 24 ]Measures the changes in the incidence of emergency department visits.
- Mortality [ Time Frame: Week 24 ]Incidence of mortality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612765
|Contact: Jocelyn H Chew, BSc(Nursing)||+firstname.lastname@example.org|