The Reliability and Validity of Turkish Version of ''The... | NCT04305639

Studies
The Reliability and Validity of Turkish Version of ''The Dyspnea-ALS-Scale (DALS-15)"

NCT04305639

Sponsor

Istanbul Medeniyet University

Status

Completed

Last Update Posted

Apr 9, 2021Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Amyotrophic Lateral Sclerosis
Dyspnea

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Apr 1, 2021Actual

Completion Date

Apr 8, 2021Actual

First Submitted Date

Mar 10, 2020

First Submission Date that Met QC Criteria

Mar 10, 2020

First Posted Date

Mar 12, 2020Actual

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

Apr 8, 2021

Last Update Posted Date

Apr 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Esma Nur KOLBAŞI, Principal Investigator, Istanbul Medeniyet UniversityPrincipal Investigator

Lead Sponsor

Istanbul Medeniyet UniversityOTHER

Collaborators

Name	Class
Istanbul University - Cerrahpasa	OTHER
Istanbul University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The Dyspnea-ALS-Scale (DALS-15) is a uni-dimensional scale to measure dyspnea in patients with Amyotrophic Lateral Sclerosis. It can be easily and rapidly applied. The aim of this study is to investigate reliability and validity of Turkish version of the DALS-15.

Detailed Description

Not provided

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

52Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Dyspnea-ALS-Scale (DALS-15)	The scale is used to measure dyspnea in ALS patients	10 minutes

Secondary Outcomes

Measure	Description	Time Frame
Modified Borg Scale	A 10 point Modified Borg Scale is used to assess dyspnea in supine and standing positions.	10 minutes
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of 18 or above
Dyspnea on exertion, dyspnea at rest, or orthopnea without evidence of pulmonary or cardiac causes of dyspnea

Exclusion Criteria:

Severe cognitive dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who are diagnosed with Amyothrophic Lateral Sclerosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ESMA NUR KOLBAŞI, MSc	Istanbul Medeniyet University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Faculty of Medicine		Istanbul		34700	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000690	Amyotrophic Lateral Sclerosis
D004417	Dyspnea

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

Browse Leaves

Not provided

Browse Branches

Not provided