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Chronic Kidney Disease(CKD)NCT06591702

Investigation of the Validity, Reliability, and Responsiveness of BETY-BQ in Chronic Kidney Disease, on Dialysis, and Kidney Transplantation

An observational study of Chronic Kidney Disease(CKD) and Chronic Kidney Disease Requiring Chronic Dialysis, run by Hacettepe University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A review of the literature has shown that Chronic Kidney Disease (CKD) is strongly associated with an increasing degree of psychosocial impact, such as depression and anxiety and a decrease in quality of life. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Questionnaire study
How many people
150 participants
Where
1 siteTurkey (Türkiye)
Study dates
21 Feb 2024to 31 Dec 2026
How long will I take part?
3 Months
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: The study population will consist of individuals who come to the university hospital for routine controls.

Who may be able to join

  • Being diagnosed with chronic kidney disease
  • To be over 18 years old
  • Consent of the participant
  • Being a dialysis patient
  • To be over 18 years old
  • Consent of the participant
Show all 9Show fewer
  • To have had a kidney transplant
  • To be over 18 years old
  • Consent of the participant

Who cannot join

  • Acute infection
  • Being diagnosed with cancer
  • Individuals on dialysis:
  • Acute infection
  • Being diagnosed with cancer
  • Kidney transplant recipients:
  • Acute infection
  • Being diagnosed with cancer

Trial locations and contacts

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

Orkun Tüfekçi, PT, PhD (c) contact

5319502648

orkuntf@gmail.com

Turkey (Türkiye)1 site, 1 recruiting

  • Hacettepe University

    Ankara, Altındağ, 06100

    Orkun Tüfekçi, PT, PhD(c), +90 312 305 25 25, orkuntf@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Validity, Reliability, and Responsiveness of BETY-Biopsychosocial Questionnaire in Individuals with Chronic Kidney Disease, on Dialysis, and Kidney Transplantation

A review of the literature has shown that Chronic Kidney Disease (CKD) is strongly associated with an increasing degree of psychosocial impact, such as depression and anxiety and a decrease in quality of life. Therefore, while determining the psychosocial aspects of the disease gains importance, it is reported that determining and evaluating the biopsychosocial characteristics may facilitate the disease management of individuals. Considering that CKD is associated with various comorbidities, psychosocial features, and symptom burden, it is interpreted that patient-reported outcome measures may support the complex management of these individuals. Routine collection and use of patient-reported outcome measures may provide valuable data for understanding the disease from both individual and community perspectives, with the potential to improve the quality of care and outcomes.

The Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise model based on physical exercise and an example of a biopsychosocial approach developed for patients with rheumatism. The BETY-Biopsychosocial Questionnaire (BETY-BQ) was created by repeated statistics of improvement characteristics reported by individuals who participated in BETY sessions for many years. The BETY-BQ holistically assesses many biopsychosocial characteristics of the person, such as pain, functionality, mood, sociability, sexuality, and sleep. Therefore, there is a need for scales that assess these symptoms holistically in chronic kidney disease. BETY-BQ can be envisaged as an assessment tool for interdisciplinary healthcare team members who want to evaluate the CKD population, including individuals on dialysis and kidney transplant recipients. Since the BETY-BQ can assess biopsychosocial characteristics quickly and its structure was created with the feedback of individuals with chronic diseases, it aimed to examine its validation in this disease group.

In this study, which investigators planned to contribute to this field, investigators aimed to investigate the validity, reliability, and sensitivity of BETY-BQ in individuals diagnosed with chronic kidney disease on dialysis and kidney transplantation.

Being tested
Questionnaire study
Keywords
biopsychosocial model, validity and reliability, BETY-BQ, Chronic Kidney Disease, Kidney Transplantation, Dialysis
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

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

  • Questionnaire studyOther

    Also called BETY-Biopsychosocial Questionnaire

    Questionnaire application

What is being measured

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

  1. BETY-Biopsychosocial Questionnaire

    The biopsychosocial status is evaluated through questions about pain, functionality, mood, sociability, sexuality, and sleep. Each question has 30 items, with scores ranging from 0 to 120, categorized as follows: 0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), and 4 (yes always). Higher scores reflect a poorer biopsychosocial status.

    Measured: Three months

Secondary outcomes (4)

  1. Hospital Anxiety Depression Scale

    The Hospital Anxiety and Depression Scale (HADS) comprises 14 items, with 7 items assessing anxiety and the other 7 evaluating depression. Each item is scored on a scale of 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate more severe levels of anxiety and depression.

    Measured: Three months

  2. Kidney Disease and Quality of Life™ (KDQOL™-36)

    The 36-item scale includes three specific dimensions: symptoms/problems, burden of kidney disease and effects of kidney disease, and physical component and mental component components derived from SF12. The scale, which consists of 5 sub-dimensions, is scored between 0-100. Higher scores indicate better health-related quality of life.

    Measured: Three months

  3. Clinical Frailty Scale

    A scale that can be easily administered in most clinical settings and is scored from 1 (very fit) to 9 (terminally ill) about fitness, active illness, activities of daily living, and cognition. The assessment is based on the subjective judgment of a clinician.

    Measured: Three months

  4. Frail Scale

    The FRAIL scale is based on a table of self-reported fatigue, mobility, strength, weight loss, and comorbidities. Each item is scored between 0-1, totaling 5 points. A high score indicates a high level of frailty.

    Measured: Three months

Timeline

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

  1. First posted19 Sep 2024
  2. Study start21 Feb 2024
  3. Primary completion21 Feb 2026 (estimated)
  4. Study completion31 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
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06591702
Sponsor's protocol ID
SBA 24/097
Status last verified
Sep 2024
First submitted
8 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Will not be shared to protect the data of individuals

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease(CKD) and Chronic Kidney Disease Requiring Chronic Dialysis, 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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Sep 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 Orkun Tüfekçi, PT, PhD (c) (5319502648, orkuntf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BETY-Biopsychosocial Questionnaire (time frame: Three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06591702.

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 19 Sep 2024.

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