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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Push-Pull-Hold Program

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 678948
    • National Heart Centre Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	Weeks 1 and 24
Mortality	Incidence of mortality.	Week 24

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: National Heart Centre Singapore
• Investigators: Principal Investigator: Jocelyn H.S. Chew, BSc(Nursing), The Nethersole School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: randomized controlled trial; heart failure; intervention; self-care; behavio*
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 201804-00157; NTEC-2018-0265 (Other Identifier: The Joint CUHK-NTEC CREC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No