The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure (PPHP)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Push-Pull-Hold Program
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure focused on measuring heart failure, self-care, behavio*, intervention, randomized controlled trial
Eligibility Criteria
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
Sites / Locations
- National Heart Centre Singapore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Participants in the intervention group will receive face-to-face intervention sessions that include interviews, discussions and didactic teaching.
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 Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03612765
First Posted
July 19, 2018
Last Updated
August 25, 2020
Sponsor
Chinese University of Hong Kong
Collaborators
National Heart Centre Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03612765
Brief Title
The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure
Acronym
PPHP
Official Title
The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
National Heart Centre Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, self-care, behavio*, intervention, randomized controlled trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive face-to-face intervention sessions that include interviews, discussions and didactic teaching.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will receive usual care that normally includes three monthly outpatient doctor consultations and when necessary, heart failure nurse referral.
Intervention Type
Behavioral
Intervention Name(s)
Push-Pull-Hold Program
Other Intervention Name(s)
PPHP
Intervention Description
Developed based on concepts of motivational interviewing, temporal framing, empowerment. It is tailored to Singaporean patients and includes contextual self-care information and tips.
Primary Outcome Measure Information:
Title
Changes in Self-Care of Heart Failure Index (SCHFI) maintenance subscale
Description
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.
Time Frame
weeks 1, 12 and 24
Secondary Outcome Measure Information:
Title
Changes in the Consideration of Future Consequences Scale (CFCS)
Description
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.
Time Frame
weeks 1, 12 and 24
Title
Changes in intention to change behaviours
Description
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.
Time Frame
weeks 1, 12 and 24
Title
Changes in the Self-Report Habit Index (SRHI)
Description
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.
Time Frame
weeks 1, 12 and 24
Title
Changes in Mindfulness Attention Awareness Scale (MAAS)
Description
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.
Time Frame
weeks 1, 12 and 24
Title
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Description
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.
Time Frame
weeks 1, 12 and 24
Other Pre-specified Outcome Measures:
Title
Changes in readmission
Description
Measures the changes in readmission incidences.
Time Frame
Weeks 1 and 24
Title
Changes in emergency department visits
Description
Measures the changes in the incidence of emergency department visits.
Time Frame
Weeks 1 and 24
Title
Mortality
Description
Incidence of mortality.
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn H.S. Chew, BSc(Nursing)
Organizational Affiliation
The Nethersole School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Heart Centre Singapore
City
Singapore
ZIP/Postal Code
678948
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure
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