跳至主要内容
临床试验/NCT06536595
NCT06536595已完成不适用

Validity and Reliability of the Turkish Version of the Hand Scleroderma Lived Experience Scale

Gazi University1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
HAnDE-T

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

HAnDE-T

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Pala

Research assistant

Gazi University

研究点 (1)

Loading locations...

相似试验

Validity and Reliability of the Turkish Version of... | 临床试验