SclerodermaNCT06536595
Validity and Reliability of the Turkish Version of HAnDE
An observational study of Scleroderma and Hand Rheumatism, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study was to translate and cross-culturally adapt The Hand Scleroderma Experienced Experience (HAnDE) Scale into the Turkish language and investigate its reliability and validity in Turkish-speaking patients with systemic sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scleroderma, Hand Rheumatism
- What is being tested?
- Scales
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: diagnosed with scleroderma
Who may be able to join
- 1) being 18-65 years of age,
- 2) being diagnosed of SSc according to do 2013 American College of Rheumatology (ACR) criteria and/or European League Against Rheumatism (EULAR) criteria,
- 3) being literate in Turkish,
- 4) being agreed to participate in the research.
Who cannot join
- 1) being in a psychological or cognitive disorders that would prevent to answer questions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Reliability of the Turkish Version of the Hand Scleroderma Lived Experience Scale
The aim of the present study was to translate and cross-culturally adapt The Hand Scleroderma Experienced Experience (HAnDE) Scale into the Turkish language and investigate its reliability and validity in Turkish-speaking patients with systemic sclerosis.
Read the detailed description
Objective: The aim of the present study was to translate and cross-culturally adapt The Hand Scleroderma Experienced Experience (HAnDE) Scale into the Turkish language and investigate its reliability and validity in Turkish-speaking patients with systemic sclerosis.
Methods: The HAnDE was cross-culturally adapted according to Beaton's guideline. Participants completed the Turkish version of HAnDE scale (HAnDE-T), The Mouth Handicap in Systemic Sclerosis Scale (MHISS), 36 Item Short Form Survey (SF-36), Health Assessment Questionnaire (HAQ). Internal consistency of the HAnDE-T questionnaire was evaluated by Cronbach's alpha coefficient. Convergent validity was tested using Pearson's correlation coefficient. The construct validity of the HAnDE-T questionnaire was assessed by factor analysis. The construct validity of the HAnDE-T was evaluated by correlating the scores between HAnDE-T and HAQ, SF-36 PCS, SF-36 MCS and MHISS scores.
- Conditions
- Scleroderma, Hand Rheumatism
- Being tested
- Scales
- Keywords
- hand, reliability, scale, validation, scleroderma
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScalesOther
Participants were asked to complete the HAnDE-T, MHISS, SF-36 and HAQ when they first came. After 1 week, they were asked to complete HAnDE-T for re-test.
| Study group | Role | What they receive |
|---|---|---|
| Study group | got diagnosed scleroderma Receives: Other: Scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAnDE-T
The Hand Scleroderma Lived Experience Scale. HAnDE is a PROM scale developed by Sibeoni et al. to assess the patient's current situation regarding his/her lived experience of global hand involvement. It consists of 16 questions that patients answer by giving a score between 0 and 4. While 0 means "I do not agree at all", 4 means "I completely agree." The total score of the HAnDE is determined by the sum of all answers given. The total score ranges from 0 to 64. Higher scores indicated higher hand involvement.
Measured: Patients were asked to complete the HAnDE-T when they first came (baseline). After 1 week, they were asked to complete HAnDE-T for retest.
Secondary outcomes (3)
MHISS
The Mouth Handicap in Systemic Sclerosis Scale. MHISS is a scale developed by Mouthon et al. to quantify the handicap associated with mouth disability in patients with SSc. The MHISS consists of 12 questions to assess mouth-related disability. Patients responded to each question by giving a score of at least 0 and maximum 4. MHISS includes three domains: mouth opening, mouth dryness and esthetic concerns. The score that can be obtained from the scale ranges from 0 to 48, with higher scores indicating more limitations. The Turkish version of the MHISS was shown to be valid and reliable.
Measured: Patients were asked to complete the MHISS when they first came (baseline).
SF-36
36-Item Short Form Survey. The SF-36 is a general quality of life assessment scale widely used to assess the quality of life. It was developed by the Rand Corporation in 1992. The SF-36 is a scale consisting of 8 sections and 36 items, including physical functionality, role limitations due to physical health problems, pain, social functionality, general health status, role limitations due to emotional problems, energy/vitality and mental health. The scale gives the total score for each subscale separately. The total score ranges from 0 to100. 0 indicates "poor health" status, 100 indicates "good health" status. The Turkish version of the SF-36 was shown to be valid and reliable.
Measured: Patients were asked to complete the SF-36 when they first came (baseline).
HAQ
Health Assessment Questionnaire. HAQ is an instrument developed to evaluate physical disability in 8 domains of the function: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activity. HAQ has been validated in patients with scleroderma. HAQ has 20 items in which patients evaluate their daily living activities by scoring between 0 and 3. The score of the test is determined by dividing the total scores given by the number of questions and varies between 0 and 3. The Turkish version of the HAQ was shown to be valid and reliable.
Measured: Patients were asked to complete the HAQ when they first came (baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Feb 2022
- Primary completion1 Jun 2022
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Other
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Pala, Gazi University
- Investigators
- Deran Oskay, Prof. Dr., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536595
- Sponsor's protocol ID
- 2021-1
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pala GG, Tore NG, Sari F, Bayram S, Vasi I, Tufan A, Oskay D. Validity and reliability of the Turkish version of the hand scleroDerma lived experience scale. J Bodyw Mov Ther. 2026 Jul;47:60-64. doi: 10.1016/j.jbmt.2026.03.012. Epub 2026 Mar 11.
PubMed 42264844
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Hand Scleroderma Lived Experience Scale
- ClinicalTrials.gov ID
- NCT06536595
- Acronym / sponsor ID
- 2021-1
- Conditions
- Scleroderma, Hand Rheumatism
- Keywords
- hand, reliability, scale, validation, scleroderma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 5 Aug 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 the present study was to translate and cross-culturally adapt The Hand Scleroderma Experienced Experience (HAnDE) Scale into the Turkish language and investigate its reliability and validity in Turkish-speaking patients with systemic sclerosis.
Detailed description
Objective: The aim of the present study was to translate and cross-culturally adapt The Hand Scleroderma Experienced Experience (HAnDE) Scale into the Turkish language and investigate its reliability and validity in Turkish-speaking patients with systemic sclerosis.
Methods: The HAnDE was cross-culturally adapted according to Beaton's guideline. Participants completed the Turkish version of HAnDE scale (HAnDE-T), The Mouth Handicap in Systemic Sclerosis Scale (MHISS), 36 Item Short Form Survey (SF-36), Health Assessment Questionnaire (HAQ). Internal consistency of the HAnDE-T questionnaire was evaluated by Cronbach's alpha coefficient. Convergent validity was tested using Pearson's correlation coefficient. The construct validity of the HAnDE-T questionnaire was assessed by factor analysis. The construct validity of the HAnDE-T was evaluated by correlating the scores between HAnDE-T and HAQ, SF-36 PCS, SF-36 MCS and MHISS scores.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Scalesgot diagnosed scleroderma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diagnosed with scleroderma
Key inclusion criteria (4 listed)
- 1) being 18-65 years of age,
- 2) being diagnosed of SSc according to do 2013 American College of Rheumatology (ACR) criteria and/or European League Against Rheumatism (EULAR) criteria,
- 3) being literate in Turkish,
- 4) being agreed to participate in the research.
Key exclusion criteria (1 listed)
- 1) being in a psychological or cognitive disorders that would prevent to answer questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScalesParticipants were asked to complete the HAnDE-T, MHISS, SF-36 and HAQ when they first came. After 1 week, they were asked to complete HAnDE-T for re-test. | Other | Study group |
Primary outcome
HAnDE-T
Time frame: Patients were asked to complete the HAnDE-T when they first came (baseline). After 1 week, they were asked to complete HAnDE-T for retest.
The Hand Scleroderma Lived Experience Scale. HAnDE is a PROM scale developed by Sibeoni et al. to assess the patient's current situation regarding his/her lived experience of global hand involvement. It consists of 16 questions that patients answer by giving a score between 0 and 4. While 0 means "I do not agree at all", 4 means "I completely agree." The total score of the HAnDE is determined by the sum of all answers given. The total score ranges from 0 to 64. Higher scores indicated higher hand involvement.
3 secondary outcomes
MHISS
Time frame: Patients were asked to complete the MHISS when they first came (baseline).
SF-36
Time frame: Patients were asked to complete the SF-36 when they first came (baseline).
HAQ
Time frame: Patients were asked to complete the HAQ when they first came (baseline).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 42264844Pala GG, Tore NG, Sari F, Bayram S, Vasi I, Tufan A, Oskay D. Validity and reliability of the Turkish version of the hand scleroDerma lived experience scale. J Bodyw Mov Ther. 2026 Jul;47:60-64. doi: 10.1016/j.jbmt.2026.03.012. Epub 2026 Mar 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Deran Oskay, Prof. Dr. study director
Gazi 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 Scleroderma and Hand Rheumatism, run by Gazi 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 4 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: finished, as of the sponsor's last update on 9 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAnDE-T (time frame: Patients were asked to complete the HAnDE-T when they first came (baseline). After 1 week, they were asked to complete HAnDE-T for retest.). 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 NCT06536595, which also lists 1 linked publication.
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 9 Aug 2024.