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Heart FailureNCT06681714

The Validity and Reliability of the Turkish Version of the Heart Failure Somatic Perception Scale

An observational study of Heart Failure, run by Hacettepe University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
How many people
100 participants
Where
1 siteTurkey (Türkiye)
Study dates
9 Dec 2024to 9 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with heart failure

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aynur Demirel, PT, PhD contact

+905545295057

aynur.demirel@hacettepe.edu.tr

Hidaye Yamikan, PT,MSc contact

hidaye.yamikan@hacettepe.edu.tr

Turkey (Türkiye)1 site
  • Hacettepe University

    Ankara

    Aynur Demirel, PT, PhD, aynur.demirel@hacettepe.edu.tr

    Hidaye Yamikan, PT,MSc, hidaye.yamikan@hacettepe.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: Kalp Yetersizliği Somatik Algı Ölçeğinin Türkçe Geçerlik Ve Güvenirlik Çalışması

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.

Read the 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.

Conditions
Heart Failure
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06681714
Study groupRoleWhat they receive
Heart FailurePatients with heart failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day

Secondary outcomes (7)
  1. The Heart Failure Symptom Status Scale

    The Heart Failure Symptom Status Scale is designed to assess the presence, frequency, severity, and impact of the seven most common symptoms in patients with heart failure.

    Patients evaluate the presence, frequency, and severity of symptoms such as dyspnea, orthopnea, fatigue, chest pain, edema, sleep disturbances, dizziness, or lightheadedness using a four-point Likert scale.

    The total score attainable on this scale ranges from 0 to 84.

    Measured: 1 day

  2. Mini mental test

    The Mini-Mental test was developed to assess cognitive impairment in adults. It is structured under five main categories: orientation, registration memory, attention and calculation, recall, and language. The test is scored on a total of 30 points. Individuals scoring 17 or below are classified as having severe dementia, those scoring between 18 and 23 are classified with mild dementia, and individuals scoring between 24 and 30 are considered not to have dementia.

    Measured: 1 day

  3. The MacNew Heart Disease-Specific Quality of Life Questionnaire

    The MacNew Heart Disease-Specific Quality of Life Questionnaire is an internationally recognized tool for measuring health-related quality of life in patients with Coronary Artery Disease (CAD).

    The questionnaire is designed to assess how physical, emotional, and social functions, as well as daily activities, are affected by CAD. The questionnaire consists of three subscales: physical limitation, emotional function, and social function, with a total of 27 items. Subscale scores are calculated by averaging the responses to the relevant items. For each subscale and for the total score, the lowest possible score is 1 and the highest is 7, with higher scores indicating better quality of life.

    Measured: 1 day

  4. Charlson Comorbity Index

    It is a mortality scoring system that includes 19 comorbidity diagnostic groups. This index is frequently used as an assessment tool for evaluating comorbidities. A score of "1 point" is assigned for the presence of myocardial infarction, congestive heart failure, peripheral vascular diseases, cerebrovascular disease, dementia, chronic pulmonary disease, connective tissue disease, ulcer disease, mild liver disease, and diabetes. A score of "2 points" is given for conditions such as hemiplegia, moderate/severe renal disease, diabetes with end-organ damage, tumors, leukemia, and malignant lymphoma. A score of "3 points" is assigned for moderate/severe liver disease, and "6 points" is given for the presence of metastatic solid tumors and AIDS. The total score is calculated by summing the individual scores, with higher scores indicating more serious conditions and a worse prognosis.

    Measured: 1 day

  5. The Minnesota Living with Heart Failure Questionnaire

    The Minnesota Living with Heart Failure Questionnaire consists of 21 items that examine the physical and emotional dimensions of heart failure. Items 2, 3, 4, 5, 6, 7, 12, and 13 assess the physical dimension, while items 17, 18, 19, 20, and 21 assess the emotional dimension. Each item is scored on a scale from 0 to 5, with a maximum possible score of 105. Higher scores indicate poorer quality of life.

    Measured: 1 day

  6. The Fatigue Severity Scale

    The Fatigue Severity Scale is a questionnaire designed to measure the severity of fatigue over the past week. It consists of 9 items, each rated on a scale from 0 to 7. The total score is obtained by summing the responses to all items and dividing the sum by 9. A score of 4 or higher typically indicates severe fatigue.

    Measured: 1 day

  7. The Leicester Questionnaire

    The Leicester Cough Questionnaire is a health-related quality of life tool specifically designed for chronic cough. It is a self-administered, easy-to-use form that evaluates the impact of chronic cough on physical, psychological, and social aspects of life. The questionnaire consists of 19 items across these three domains, and it uses a 7-point Likert scale for responses.

    Higher scores on the LCQ indicate that the individual is less affected by the cough, reflecting better overall health. The total score is the sum of the scores from the physical, psychological, and social domains.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study start9 Dec 2024 (estimated)
  3. Primary completion9 Jun 2025 (estimated)
  4. Study completion9 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06681714
Sponsor's protocol ID
SBA 24/702
Status last verified
Nov 2024
First submitted
7 Nov 2024
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Hacettepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aynur Demirel, PT, PhD (+905545295057, aynur.demirel@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Heart Failure Somatic Perception Scale (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.

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