Hand ScleroDerma Lived Experience Scale in Individuals With Systemic Sclerosis

NCT06658483 | Enrolling By Invitation

• 1 other identifier: Validity and Reliability
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study was to examine the Turkish validity and reliability of the Hand scleroDerma lived Experience Scale (HAnDE Scale) Questionnaire in individuals with SSc.

Conditions

Systemic Sclerosis (SSc); Hand Function

Outcome Measures

Primary Outcomes (1)

• Hand ScleroDerma Lived Experience Scale (HAnDE Scale) Questionnaire

  The scale consists of 18 items regarding the patient-reported status of hand function in individuals with SSc. Each response ranges from 0 to 4. 0 means 'completely disagree' and 4 means 'completely agree'. The higher the scale score, the worse the experience with the hand

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Secondary Outcomes (4)

• Hand Mobility in Scleroderma Test

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

• Scleroderma Skin Involvement: Patient-Reported Outcomes

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

• Modified Rodnan Skin Thickness Score

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

• Scleroderma Health Assessment Questionnaire

  Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Eligibility Criteria

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

Study Population

The study will include individuals aged 18 and older who are receiving treatment for Systemic Sclerosis at two university hospital in Turkey, and meet the inclusion and exclusion criteria.

You may qualify if:

• Being diagnosed with Systemic Sclerosis by a rheumatologist
• Being 18 years of age or older,

You may not qualify if:

• Presence of neurological disease
• Presence of any orthopedic problem that will affect functionality
• Presence of orthopedic surgery history
• Inability to speak or understand Turkish fluently.
• Presence of psychiatric disease that will affect cooperation.
• Severe neurological disease that will affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident).
• Heart failure and lung pathology that will affect daily living activities.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (2)

Inonu University

Malatya, Malatya, Turkey (Türkiye)

Location

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): September 24, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

TU (2)