DementiaDementiaNCT06191172
The Effect of Person-Centered Care Applied to Patients With Dementia on Nutritional Status
A study testing Reminiscence Therapy, Montessori application and Environmental Layout in people with Dementia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Reminiscence Therapy, Montessori application and Environmental Layout
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2021to Jun 2024
- Phase
- Interventional
- 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
Who may be able to join
- Being over 65 years old,
- Being diagnosed with dementia
- Being able to step on the scale (no lower extremity loss)
Who cannot join
- Acute disease state (pneumonia),
- Patients with PEG,
- Patients with severe visual and hearing impairment,
- Mild dementia patients,
- Parkinson\'s patients,
- Patients with head trauma
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
In line with the observations made and the patient\'s wishes, Montessori application, landscaping, special equipment such as high-contrast colored crockery, flatware, and spill-free containers, positive communication, effectiveness Person-centered care interventions such as activities will be implemented and their effects on nutritional status will be evaluated (Pre-test - post-test).
test randomized control group experimental design). No intervention will be made to the control group, they will only be observed.
- Conditions
- Dementia
- Being tested
- Reminiscence Therapy, Montessori application, Environmental Layout, Application of contrast ergonomic special equipment
- Keywords
- dementia, person-centered, Edfed, feeding difficulty
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminiscence TherapyBehavioural
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.
Montessori applicationBehavioural
Drill toy Matching puzzle Chickpeas, rice sorting Lock, zipper Counting beans Making a tie Taking and pouring food with a scoop
Environmental LayoutBehavioural
Dining place Music Lighting Heat
Application of contrast ergonomic special equipmentBehavioural
White tablecloth Beveled red blue and yellow blue plate Ergonomic yellow and red fork, spoon and cup
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENT I | Experimental | Reminiscence therapy intervention group Receives: Behavioral: Reminiscence Therapy |
| EXPERIMENT II | Experimental | Montessori application initiative group Receives: Behavioral: Montessori application |
| EXPERIMENT III | Experimental | Environmental initiative group Receives: Behavioral: Environmental Layout |
| EXPERIMENT IV | Experimental | Application of contrast ergonomic special equipment initiative group Receives: Behavioral: Application of contrast ergonomic special equipment |
| CONTROL GROUP | No intervention | ORDINARY CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edfed score
Change in edfed score after one month of application
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start20 Dec 2021
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Kul, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191172
- Sponsor's protocol ID
- IstanbulUC-2022/10
- Acronym
- Dementia
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Person-Centered Care Applied to Patients With Dementia on Nutritional Status
- ClinicalTrials.gov ID
- NCT06191172
- Acronym / sponsor ID
- Dementia / IstanbulUC-2022/10
- Conditions
- Dementia
- Keywords
- dementia, person-centered, Edfed, feeding difficulty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 5 Jan 2024 (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.
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.
Detailed description
In line with the observations made and the patient\'s wishes, Montessori application, landscaping, special equipment such as high-contrast colored crockery, flatware, and spill-free containers, positive communication, effectiveness Person-centered care interventions such as activities will be implemented and their effects on nutritional status will be evaluated (Pre-test - post-test).
test randomized control group experimental design). No intervention will be made to the control group, they will only be observed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENT I | Experimental | Behavioral: Reminiscence TherapyReminiscence therapy intervention group |
| EXPERIMENT II | Experimental | Behavioral: Montessori applicationMontessori application initiative group |
| EXPERIMENT III | Experimental | Behavioral: Environmental LayoutEnvironmental initiative group |
| EXPERIMENT IV | Experimental | Behavioral: Application of contrast ergonomic special equipmentApplication of contrast ergonomic special equipment initiative group |
| CONTROL GROUP | No intervention | –ORDINARY CARE |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Being over 65 years old,
- Being diagnosed with dementia
- Being able to step on the scale (no lower extremity loss)
Key exclusion criteria (6 listed)
- Acute disease state (pneumonia),
- Patients with PEG,
- Patients with severe visual and hearing impairment,
- Mild dementia patients,
- Parkinson\'s patients,
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 |
|---|---|---|
| Reminiscence TherapyOld 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. | Behavioural | EXPERIMENT I |
| Montessori applicationDrill toy Matching puzzle Chickpeas, rice sorting Lock, zipper Counting beans Making a tie Taking and pouring food with a scoop | Behavioural | EXPERIMENT II |
| Environmental LayoutDining place Music Lighting Heat | Behavioural | EXPERIMENT III |
| Application of contrast ergonomic special equipmentWhite tablecloth Beveled red blue and yellow blue plate Ergonomic yellow and red fork, spoon and cup | Behavioural | EXPERIMENT IV |
Primary outcome
Edfed score
Time frame: one month
Change in edfed score after one month of application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reminiscence Therapy, Montessori application and Environmental Layout in people with Dementia, 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 6 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. 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?
Results are not available in the source record.
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: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.