DementiaEdFedNCT06889103
Turkish Edinburgh Feeding Evaluation in Dementia (EdFed) Scale
An observational study of Dementia and Feeding Difficulties, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Feeding Difficulties, Reliability and Validity
- What is being tested?
- Observation
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Nursing home
Who may be able to join
- Those over the age of 65,
- Those diagnosed with dementia,
- Patients who are able to weigh themselves (no lower extremity loss)
Who cannot join
- (CDR<2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychometric Properties of the Turkish Version of the Edinburgh Feeding Evaluation in Dementia (EdFed) Scale
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.
Read the 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.
- Conditions
- Dementia, Feeding Difficulties, Reliability and Validity
- Being tested
- Observation
- Keywords
- dementia, EdFed, interobserver agreement
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
observation during eating
| Study group | Role | What they receive |
|---|---|---|
| Observed | observation during eating Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edfed score
Psychometric properties of the Turkish version of the Edinburgh Feeding Evaluation in Dementia (EdFed) scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Jan 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Kul, Istanbul University - Cerrahpasa
- Investigators
- Büşra Kul, MsC, Principal investigator, ÜSKÜDAR ÜNİVERSİTESİZelıha Tulek, Proffessor, Study director, İstanbul University-Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889103
- Sponsor's protocol ID
- Edfed scale
- Acronym
- EdFed
- Status last verified
- Mar 2025
- First submitted
- 16 Jan 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It can be shared after publication.
Publications
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.
PubMed 26608444
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of the Turkish Version of the Edinburgh Feeding Evaluation in Dementia (EdFed) Scale
- ClinicalTrials.gov ID
- NCT06889103
- Acronym / sponsor ID
- EdFed / Edfed scale
- Conditions
- Dementia, Feeding Difficulties, Reliability and Validity
- Keywords
- dementia, EdFed, interobserver agreement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed | – | Other: Observationobservation during eating |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Nursing home
Key inclusion criteria (3 listed)
- Those over the age of 65,
- Those diagnosed with dementia,
- Patients who are able to weigh themselves (no lower extremity loss)
Key exclusion criteria (1 listed)
- (CDR<2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observationobservation during eating | Other | Observed |
Primary outcome
Edfed score
Time frame: 1 year
Psychometric properties of the Turkish version of the Edinburgh Feeding Evaluation in Dementia (EdFed) scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Results publication: PubMed 26608444Bagnasco 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.
- Individual participant dataSharing planned: Undecided. It can be shared after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Büşra Kul, MsC principal investigator
ÜSKÜDAR ÜNİVERSİTESİ
Zelıha Tulek, Proffessor study director
İstanbul University-Cerrahpaşa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Feeding Difficulties, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edfed score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06889103, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.