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

Heart Failure Clinical Trial

— PPHP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612765
• Other study ID #: 201804-00157
• Secondary ID: NTEC-2018-0265
• Status: Completed
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	National Heart Centre Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in readmission	Measures the changes in readmission incidences.	Weeks 1 and 24
Other	Changes in emergency department visits	Measures the changes in the incidence of emergency department visits.	Weeks 1 and 24
Other	Mortality	Incidence of mortality.	Week 24
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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