NCT06889103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

January 16, 2025

Last Update Submit

March 16, 2025

Conditions

DementiaFeeding DifficultiesReliability and Validity

Keywords

dementiaEdFedinterobserver agreement

Outcome Measures

Primary Outcomes (1)

  • Edfed score

    Psychometric properties of the Turkish version of the Edinburgh Feeding Evaluation in Dementia (EdFed) scale

    1 year

Study Arms (1)

Observed

observation during eating

Other: Observation

Interventions

ObservationOTHER

observation during eating

Observed

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nursing home

You may qualify if:

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

You may not qualify if:

  • (CDR\<2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Darülaceze

Istanbul, Sıslı, 34394, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 26608444BACKGROUND

MeSH Terms

Conditions

Dementia

Interventions

Observation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Büşra Kul, MsC

    ÜSKÜDAR ÜNİVERSİTESİ

    PRINCIPAL INVESTIGATOR

  • Zelıha Tulek, Proffessor

    İstanbul University-Cerrahpaşa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 16, 2025

First Posted

March 21, 2025

Study Start

January 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations

TU(1)