Validity and Reliability of the Turkish Version of HAnDE

NCT06536595 | Completed DMC

• 1 other identifier: 2021-1
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scleroderma; Hand Rheumatism

Keywords

hand; reliability; scale; validation; scleroderma

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Patients were asked to complete the MHISS when they first came (baseline).

• SF-36

  Patients were asked to complete the SF-36 when they first came (baseline).

• HAQ

  Patients were asked to complete the HAQ when they first came (baseline).

Study Arms (1)

Study group

got diagnosed scleroderma

Other: Scales

Interventions

Scales OTHER

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

diagnosed with scleroderma

You may qualify if:

• \) being 18-65 years of age,
• \) being diagnosed of SSc according to do 2013 American College of Rheumatology (ACR) criteria and/or European League Against Rheumatism (EULAR) criteria,
• \) being literate in Turkish,
• \) being agreed to participate in the research.

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Amasya University

Amasya, 05000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Deran Oskay, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 5, 2024
• Study Start: February 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)