Turkish Edinburgh Feeding Evaluation in Dementia (EdFed)... | NCT06889103

Studies
Turkish Edinburgh Feeding Evaluation in Dementia (EdFed) Scale

NCT06889103

Sponsor

Istanbul University - Cerrahpasa

Status

Completed

Last Update Posted

Mar 21, 2025Actual

Enrollment

55Actual

Phase

Not provided

Conditions

Dementia
Feeding Difficulties
Reliability and Validity

Interventions

Observation

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

Mar 2025

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

Jan 1, 2022Actual

Primary Completion Date

Jul 1, 2022Actual

Completion Date

Jul 1, 2022Actual

First Submitted Date

Jan 16, 2025

First Submission Date that Met QC Criteria

Mar 16, 2025

First Posted Date

Mar 21, 2025Actual

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

Mar 16, 2025

Last Update Posted Date

Mar 21, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Busra Kul, Principal Investigator, Istanbul University - CerrahpasaPrincipal Investigator

Lead Sponsor

Istanbul University - CerrahpasaOTHER

Collaborators

Not provided

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

This study was conducted to evaluate the psychometric properties, including interobserver agreement, of the Turkish version of the Edinburgh Feeding Evaluation in Dementia (EdFed) scale, which was developed to assess eating difficulties in patients with dementia.

Detailed Description

Eating difficulties are common in dementia patients and can lead to malnutrition. Early detection and intervention of these difficulties is of great importance to minimise the negative effects. Therefore, a reliable and valid tool for assessing nutritional difficulties in dementia patients is needed.

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

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observed		observation during eating	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	observation during eating	Observed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Edfed score	Psychometric properties of the Turkish version of the Edinburgh Feeding Evaluation in Dementia (EdFed) scale	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those over the age of 65,
Those diagnosed with dementia,
Patients who are able to weigh themselves (no lower extremity loss)

Exclusion Criteria:

• (CDR<2)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Nursing home

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Büşra Kul, MsC	ÜSKÜDAR ÜNİVERSİTESİ	Principal Investigator
Zelıha Tulek, Proffessor	İstanbul University-Cerrahpaşa	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Darülaceze		Istanbul	Sıslı	34394	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26608444	Result	Bagnasco A, Watson R, Zanini M, Rosa F, Rocco G, Sasso L. Preliminary testing using Mokken scaling of an Italian translation of the Edinburgh Feeding Evaluation in Dementia (EdFED-I) scale. Appl Nurs Res. 2015 Nov;28(4):391-6. doi: 10.1016/j.apnr.2015.02.003. Epub 2015 Feb 26.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

ID	Term
D008722	Methods
D008919	Investigative Techniques