Validity and Reliability of the Turkish Version of HAnDE

August 6, 2024 updated by: Gamze Pala, Gazi University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Amasya, Turkey, 05000
        • Amasya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

diagnosed with scleroderma

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 1) being in a psychological or cognitive disorders that would prevent to answer questions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
got diagnosed scleroderma
Other: Scales
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
MHISS
Time Frame: Patients were asked to complete the MHISS when they first came (baseline).
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.
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).
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.
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).
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.
Patients were asked to complete the HAQ when they first came (baseline).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Study Director: Deran Oskay, Prof. Dr., Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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