Skip to main content
OpenTrials
Completed

NCT Number: NCT03612765

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Heart Centre Singapore

Singapore, 678948

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PPHP

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. Changes in readmission

    Time frame: Weeks 1 and 24

    Measures the changes in readmission incidences.

  2. Changes in emergency department visits

    Time frame: Weeks 1 and 24

    Measures the changes in the incidence of emergency department visits.

  3. Mortality

    Time frame: Week 24

    Incidence of mortality.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • National Heart Centre Singapore

Registry information

Official study title

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

Acronym: PPHP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 2, 2018
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.