NCT05420688

Brief Summary

The aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the European Heart Failure Self-Care Behavior Questionnaire for Caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

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

June 11, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

June 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

June 11, 2022

Last Update Submit

January 19, 2024

Conditions

Heart FailureSelf Care

Keywords

Heart FailureValidity and ReliabilitySelf Care

Outcome Measures

Primary Outcomes (2)

  • European Heart Failure Self-Care Behavior Scale for Caregivers

    Using a five-point Likert scale, patients report the extent to which they agree with the statements corresponding to the 9-item self-care behavior (for example, weighing oneself every day), with responses ranging from "totally agree" to "disagree".

    Baseline

  • Scale of Caregiver Contribution in Heart Failure Self-Care

    "Caregiver contribution scale in heart failure self-care", which consists of 22 items, consists of 3 separate scales.

    Baseline

Interventions

Heart Failure GroupOTHER

This is a single-center, prospective, observational study. The assessment and reporting will be followed the Consensus-Based Standards for the Selection of Health Status Measurement Instruments (COSMIN) checklist.

Also known as: Assesment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with Heart Failure

You may qualify if:

  • be over 18
  • To be a caregiver for patients with heart failure for at least 1 year.
  • Volunteer to participate in the research.

You may not qualify if:

  • Having communication problems and mental problems.
  • be under the age of 18.
  • Receiving hemodialysis treatment for less than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University

Sanliurfa, Türki̇ye, 63000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • İbrahim C Di̇ki̇ci̇, MSc

    Harran Üniversitesi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 11, 2022

First Posted

June 15, 2022

Study Start

June 12, 2022

Primary Completion

September 10, 2022

Study Completion

September 10, 2023

Last Updated

January 22, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)