Cross-cultural Adaptation of the 'Cold Intolerance Severi... | NCT05925907

Studies
Cross-cultural Adaptation of the 'Cold Intolerance Severity Score' (CISS) to the Dutch Language.

NCT05925907

Sponsor

Erasmus Medical Center

Status

Unknown status

Last Update Posted

Dec 21, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Hand Injuries

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2023Actual

Primary Completion Date

Jan 1, 2024Estimated

Completion Date

Jan 1, 2025Estimated

First Submitted Date

Jun 13, 2023

First Submission Date that Met QC Criteria

Jun 22, 2023

First Posted Date

Jun 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2023

Last Update Posted Date

Dec 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Reinier Feitz, MD PhD, Reinier Feitz, MD, PhD, plastic surgeon, Erasmus Medical CenterPrincipal Investigator

Lead Sponsor

Erasmus Medical CenterOTHER

Collaborators

Name	Class
Handcentrum, Bilthoven, The Netherlands	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To report Cold intolerance by the CISS score in medicolegal patients.

Detailed Description

Rationale Cold intolerance is an important finding in hand trauma patients, nerve injury, crush injury, degloving injury or amputation. Cold intolerance as a symptom is probably the least responsive to any known medical treatment.

Perhaps due to the fact that we have no control over it, the consequences for cold tolerance are seldom researched. patients involved in medicolegal claims report more pain and less function than controls. Medicolegal examinations for various indications offer a long-term outcome view for the symptoms of cold tolerance. Therefore, together with Handcentrum we want to translate, improve and test the current PROM for cold intolerance CISS

Objective To report Coldintolerance by the CISS score in medicolegal patients.

Study parameters / Endpoints A validated Dutch version of the CISS A report on 100 CISS scores in medicolegal patients Examine if a shorter version of the CISS questionnaire is feasible

Study design 2-3 independent forward translations (e.g. from English into Dutch) by native speakers of the target language (e.g. Dutch). One of the translators understands the concept, one translator has no knowledge of the concept that the questionnaire measures and no medical background.

The translators make a joint forward translation together with an independent person.

2-3 independent back-translations (e.g. from Dutch into English) by native speakers of the source language (e.g. English). Both translators have no knowledge of the concept the questionnaire measures and have no medical background. ... Read more

Burden and risk These questionnaires are mandatory anyway. So, no additional time for the patients needed. There is no risk involved. There is no alteration in the medical or clinical pathway.

Recruitment and consent automatically enrolment and permission via Medisoft software from HandC

Summary Translation and validation of a Dutch version of a PROM for cold intolerance

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Handsurgery patients		patients recruited from trauma handsurgery outpatient clinic in an academic teaching hospital, level 1 trauma unit.
Medicolegal patients		Medicolegal patients that are examined in order to asses their personal injury claim.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validation of a Dutch language translation of standard cold intolerance form	Test and retest of a Dutch language model of the CISS score	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Adult
Traumatic hand injury
Sufficient knowledge of the Dutch language (at least level B1)

Exclusion Criteria:

- Definitive total hand amputation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Handsurgery patients and medicolegal patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Reinier Feitz, MD PhD	Contact	0303200556		info@handcentrum.nl

Overall Officials

Name	Affiliation	Role
Reinier Feitz, MD PhD	Erasmus Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasmuc MC	Recruiting	Rotterdam	South Holland	3015 GD	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006230	Hand Injuries
C536214	Crisponi syndrome
D003668	Pressure Ulcer

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided