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Heart FailurePPHPNCT03612765

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

A study testing Push-Pull-Hold Program in people with Heart Failure, run by Chinese University of Hong Kong at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 100 years
Conditions the study is for
Heart Failure
What is being tested?
Push-Pull-Hold Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteSingapore
Study dates
12 Sep 2018to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinically diagnosed with chronic heart failure for at least 1 month
  • More than 21 years old
  • Able to read and understand English or Chinese

Who cannot join

  • Dependent on caregivers
  • Awaiting implantable devices or surgery
  • Pregnant

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Heart Centre Singapore

    Singapore, 678948

Other trials in Singapore

About this study

Official title: 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.

Conditions
Heart Failure
Being tested
Push-Pull-Hold Program
Keywords
heart failure, self-care, behavio*, intervention, randomized controlled trial
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Push-Pull-Hold ProgramBehavioural

    Also called PPHP

    Developed based on concepts of motivational interviewing, temporal framing, empowerment. It is tailored to Singaporean patients and includes contextual self-care information and tips.

Study groups in NCT03612765
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants in the intervention group will receive face-to-face intervention sessions that include interviews, discussions and didactic teaching.
Receives: Behavioral: Push-Pull-Hold Program
Control groupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: weeks 1, 12 and 24

Secondary outcomes (5)

  1. 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.

    Measured: weeks 1, 12 and 24

  2. 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.

    Measured: weeks 1, 12 and 24

  3. 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.

    Measured: weeks 1, 12 and 24

  4. 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.

    Measured: weeks 1, 12 and 24

  5. 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.

    Measured: weeks 1, 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2018
  2. Study start12 Sep 2018
  3. Primary completion31 Mar 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03612765
Sponsor's protocol ID
201804-00157
Other IDs
NTEC-2018-0265
Acronym
PPHP
Status last verified
Aug 2020
First submitted
19 Jul 2018
Last updated
27 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Push-Pull-Hold Program in people with Heart Failure, run by Chinese University of Hong Kong at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Self-Care of Heart Failure Index (SCHFI) maintenance subscale (time frame: weeks 1, 12 and 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03612765.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.

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