NCT06191172

Brief Summary

The aim of this study is to examine the effect of person-centered care on nutritional status of patients with dementia. In this study, we think that since the practices that reduce the eating difficulties of patients with dementia and prevent possible problems will be applied in a person-centered manner, a different perspective will be developed in this field and will affect the care of the patients more positively.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 20, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

2.3 years

First QC Date

December 20, 2023

Last Update Submit

December 20, 2023

Conditions

Keywords

dementiaperson-centeredEdfedfeeding difficulty

Outcome Measures

Primary Outcomes (1)

  • Edfed score

    Change in edfed score after one month of application

    one month

Study Arms (5)

EXPERIMENT I

EXPERIMENTAL

Reminiscence therapy intervention group

Behavioral: Reminiscence Therapy

EXPERIMENT II

EXPERIMENTAL

Montessori application initiative group

Behavioral: Montessori application

EXPERIMENT III

EXPERIMENTAL

Environmental initiative group

Behavioral: Environmental Layout

EXPERIMENT IV

EXPERIMENTAL

Application of contrast ergonomic special equipment initiative group

Behavioral: Application of contrast ergonomic special equipment

CONTROL GROUP

NO INTERVENTION

ORDINARY CARE

Interventions

Old objects and pictures of old objects that facilitate remembering about weekly topics will be taken to the institution by the researcher, and individuals within the scope of the research will be asked for their own photographs, if any.

EXPERIMENT I

Drill toy Matching puzzle Chickpeas, rice sorting Lock, zipper Counting beans Making a tie Taking and pouring food with a scoop

EXPERIMENT II

Dining place Music Lighting Heat

EXPERIMENT III

White tablecloth Beveled red blue and yellow blue plate Ergonomic yellow and red fork, spoon and cup

EXPERIMENT IV

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being over 65 years old,
  • Being diagnosed with dementia
  • Being able to step on the scale (no lower extremity loss)

You may not qualify if:

  • Acute disease state (pneumonia),
  • Patients with PEG,
  • Patients with severe visual and hearing impairment,
  • Mild dementia patients,
  • Parkinson\'s patients,
  • Patients with head trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey

Istanbul, Sıslı, 34394, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC

Study Record Dates

First Submitted

December 20, 2023

First Posted

January 5, 2024

Study Start

December 20, 2021

Primary Completion

April 1, 2024

Study Completion

June 1, 2024

Last Updated

January 5, 2024

Record last verified: 2023-12

Locations