NCT03612765

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 12, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

July 19, 2018

Last Update Submit

August 25, 2020

Conditions

Heart Failure

Keywords

heart failureself-carebehavio*interventionrandomized controlled trial

Outcome Measures

Primary Outcomes (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.

    weeks 1, 12 and 24

Secondary Outcomes (5)

  • Changes in the Consideration of Future Consequences Scale (CFCS)

    weeks 1, 12 and 24

  • Changes in intention to change behaviours

    weeks 1, 12 and 24

  • Changes in the Self-Report Habit Index (SRHI)

    weeks 1, 12 and 24

  • Changes in Mindfulness Attention Awareness Scale (MAAS)

    weeks 1, 12 and 24

  • Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    weeks 1, 12 and 24

Other Outcomes (3)

  • Changes in readmission

    Weeks 1 and 24

  • Changes in emergency department visits

    Weeks 1 and 24

  • Mortality

    Week 24

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention group will receive face-to-face intervention sessions that include interviews, discussions and didactic teaching.

Behavioral: Push-Pull-Hold Program

Control group

NO INTERVENTION

Participants in the control group will receive usual care that normally includes three monthly outpatient doctor consultations and when necessary, heart failure nurse referral.

Interventions

Push-Pull-Hold ProgramBEHAVIORAL

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

Also known as: PPHP
Intervention group

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Centre Singapore

Singapore, 678948, Singapore

Location

MeSH Terms

Conditions

Heart Failure

Interventions

5-phenylpent-4-enyl-1-hydroperoxide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jocelyn H.S. Chew, BSc(Nursing)

    The Nethersole School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 2, 2018

Study Start

September 12, 2018

Primary Completion

March 31, 2019

Study Completion

December 31, 2019

Last Updated

August 27, 2020

Record last verified: 2020-08

Locations

SG(1)