Clinical trial NCT06681714: The Validity and Reliability of the Turkish Version of the Heart Failure Somatic Perception Scale
Official title: Kalp Yetersizliği Somatik Algı Ölçeğinin Türkçe Geçerlik Ve Güvenirlik Çalışması
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure

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.

Detailed description: Heart failure is a global health issue that serves as the endpoint for many cardiovascular conditions, particularly coronary heart disease and hypertension. Common symptoms of heart failure include fatigue, dyspnea, edema, cough, lack of energy, orthopnea, paroxysmal nocturnal dyspnea, palpitations, and dizziness. These symptoms significantly affect the health-related quality of life of individuals with heart failure, especially in the palliative phase of the disease. Additionally, heart failure patients often experience physical limitations, reduced quality of life, and an increased rate of hospital admissions due to symptoms such as breathlessness and fatigue. The Heart Failure Somatic Perception Scale assesses the presence and severity of 18 common physical signs and symptoms of heart failure (e.g. chest pain), as well as dyspnea and its impact on daily activities through six items. Robust and rigorous measures are needed to assess the complexity of heart failure symptoms, and evidence suggests that evaluating a broad range of heart failure symptoms can be beneficial in guiding rehabilitation approaches, clinical decision-making, and survival prediction.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Primary outcomes:
measure: The Heart Failure Somatic Perception Scale
timeFrame: 1 day
Secondary outcomes:
measure: The Heart Failure Symptom Status Scale
timeFrame: 1 day
measure: Mini mental test
timeFrame: 1 day
measure: The MacNew Heart Disease-Specific Quality of Life Questionnaire
timeFrame: 1 day
measure: Charlson Comorbity Index
timeFrame: 1 day
measure: The Minnesota Living with Heart Failure Questionnaire
timeFrame: 1 day
measure: The Fatigue Severity Scale
timeFrame: 1 day
measure: The Leicester Questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Aynur Demirel, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: