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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
Sponsor:
Collaborator:
National Heart Centre Singapore
Information provided by (Responsible Party):
Jocelyn Chew, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Heart Failure Behavioral: Push-Pull-Hold Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Jocelyn H Chew, BSc(Nursing) +6598394881 jocelyn.chew.hs@link.cuhk.edu.hk

Sponsors and Collaborators
Chinese University of Hong Kong
National Heart Centre Singapore

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Responsible Party: Jocelyn Chew, Principal Investigator, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03612765     History of Changes
Other Study ID Numbers: 201804-00157
NTEC-2018-0265 ( Other Identifier: The Joint CUHK-NTEC CREC )
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jocelyn Chew, Chinese University of Hong Kong:
heart failure
self-care
behavio*
intervention
randomized controlled trial
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases