NCT07721909

Brief Summary

This is a pilot randomized clinical trial that have employed a motivational interviewing intervention to enhance self-care in heart failure patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jan 2020

Longer than P75 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

Study Start

First participant enrolled

January 1, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2024

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 23, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

March 8, 2026

Last Update Submit

July 18, 2026

Conditions

Keywords

Heart failureomanmotivationtelehealthnurse

Outcome Measures

Primary Outcomes (2)

  • The Self Care of Heart Failure Index

    The Self-Care of Heart Failure Index (SCHFI) Version 6.2) is a validated self-report instrument that measures self-care among individuals with heart failure. It consists of 22 items across three subscales: self-care maintenance (10 items), self-care management (6 items), and self-care confidence (6 items). Scores for each subscale are standardised to a 0-100 scale, with higher scores indicating better self-care. A score of ≥70 is considered indicative of adequate self-care

    At enrolment then at six and nine months

  • Heart Failure Somatic Perception Scale (HFSPS v.3)

    The 18-item Heart Failure Somatic Perception Scale (HFSPS v.3) is a validated self-report instrument that assesses the severity and burden of physical symptoms experienced by individuals with heart failure, such as dyspnea, fatigue, edema, and sleep disturbances. The total score ranges from 0 to 90, with higher scores indicating greater symptom burden and worse symptom perception. Scores are categorised as 0-18 (minimal), 19-36 (mild), 37-54 (moderate), 55-72 (high), and 73-90 (very high) symptom burden.

    At enrolment and then at six and nine months

Study Arms (2)

Standard

NO INTERVENTION

This is the control group who will get education materials standard

Motivational

EXPERIMENTAL

this group will receive motivational interviewing and education in addition to telephonic follow up

Behavioral: Motivational interviewingOther: Standard Care (Treatment as Usual)

Interventions

this group will receive motivational interviewing and education in addition to telephonic follow up

Motivational

the patients will get standard care and educational materials

Motivational

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic adults who are 18 years and older with a heart failure diagnosis --Participants who are able to self-report their experience
  • English or Arabic speakers

You may not qualify if:

  • \- Patients who have a record of cognitive impairment (e.g. Alzheimer's), major psychiatric disorders (e.g. Depression), or concurrent terminal illness (e.g. terminal cancers)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

sULTAN qABOOS uNIVERSITY

Muscat, 123, Oman

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Motivational InterviewingStandard of CareTherapeutics

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and ServicesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

March 8, 2026

First Posted

July 23, 2026

Study Start

January 1, 2020

Primary Completion

February 2, 2024

Study Completion

February 2, 2024

Last Updated

July 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations