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).
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.
Hidaye Yamikan, PT,MSc contact
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
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 group | Role | What they receive |
|---|---|---|
| Heart Failure | Patients with heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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.
- First posted8 Nov 2024
- Study start9 Dec 2024 (estimated)
- Primary completion9 Jun 2025 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Demirel, Hacettepe University
- Investigators
- Aynur Demirel, PT, PhD, Principal investigator, Hacettepe University
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kalp Yetersizliği Somatik Algı Ölçeğinin Türkçe Geçerlik Ve Güvenirlik Çalışması
- ClinicalTrials.gov ID
- NCT06681714
- Acronym / sponsor ID
- SBA 24/702
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 9 Dec 2024 (estimated)
- Primary completion
- 9 Jun 2025 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | – | –Patients with heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Known cognitive impairment. Having undergone acute coronary syndrome, percutaneous coronary intervention, or heart surgery within the past three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Heart Failure Somatic Perception Scale
Time frame: 1 day
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.
7 secondary outcomes
The Heart Failure Symptom Status Scale
Time frame: 1 day
Mini mental test
Time frame: 1 day
The MacNew Heart Disease-Specific Quality of Life Questionnaire
Time frame: 1 day
Charlson Comorbity Index
Time frame: 1 day
The Minnesota Living with Heart Failure Questionnaire
Time frame: 1 day
The Fatigue Severity Scale
Time frame: 1 day
The Leicester Questionnaire
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hidaye Yamikan, PT,MSc contact
Aynur Demirel, PT, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
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.