NCT06681714

Brief Summary

The aim of this study is to evaluate The Validity and Reliability of the Turkish Version of the Heart Failure Somatic Perception Scale in patients with heart failure.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress83%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

November 7, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 9, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2026

Expected
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 7, 2024

Last Update Submit

November 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Heart Failure Somatic Perception Scale

    The Heart Failure Somatic Perception Scale comprises 18 items that assess how much the main signs and symptoms of heart failure have distressed the individual over the past week. Each item is rated on a five-point Likert scale, ranging from 0, indicating "did not experience this symptom," to 5, indicating "severe distress." The total score is obtained by summing the scores of all items, yielding a range from 0 to 90. A higher score indicates a greater impact of heart failure symptoms on the patient's life. Turkish version of The Heart Failure Somatic Perception Scale will be applied.

    1 day

Secondary Outcomes (7)

  • The Heart Failure Symptom Status Scale

    1 day

  • Mini mental test

    1 day

  • The MacNew Heart Disease-Specific Quality of Life Questionnaire

    1 day

  • Charlson Comorbity Index

    1 day

  • The Minnesota Living with Heart Failure Questionnaire

    1 day

  • +2 more secondary outcomes

Study Arms (1)

Heart Failure

Patients with heart failure

Eligibility Criteria

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

Patients with heart failure

You may qualify if:

  • A diagnosis of heart failure. Use of optimal pharmacological treatment according to current guidelines for at least 3 months.
  • Functional capacity classified as New York Heart Association (NYHA) Class I-IV (ambulatory).
  • Age 18 or older. Ability to cooperate with measurements.

You may not qualify if:

  • Known cognitive impairment. Having undergone acute coronary syndrome, percutaneous coronary intervention, or heart surgery within the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Aynur Demirel, PT, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aynur Demirel, PT, PhD

CONTACT

Hidaye Yamikan, PT,MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD

Study Record Dates

First Submitted

November 7, 2024

First Posted

November 8, 2024

Study Start

December 9, 2024

Primary Completion

June 9, 2025

Study Completion (Estimated)

December 9, 2026

Last Updated

November 8, 2024

Record last verified: 2024-11

Locations