DYSPHAGIANCT06269575
Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia
A study testing SAFE NUTRITION PROGRAM in people with DYSPHAGIA, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
It was planned in a quasi-experimental design with a non-randomized control group. The study was planned to be completed in three stages: control, preparation and intervention periods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DYSPHAGIA
- What is being tested?
- SAFE NUTRITION PROGRAM
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2020to 15 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute stroke patients
- 18 years and over
Who cannot join
- those who do not want to be involved in the study
Trial locations and contacts
1 site in 1 country.
About this study
It was planned in a quasi-experimental design with a non-randomized control group. The study was planned to be completed in three stages: control, preparation and intervention periods.
Question 1: Does a safe nutrition program prevent aspiration pneumonia, dehydration and malnutrition in acute stroke patients with dysphagia? Question 2: Is the safe nutrition program effective on addiction level, quality of life and depression in acute stroke patients with dysphagia? Question 3: Does a safe nutrition program shorten the hospital stay and NG tube duration in acute stroke patients with dysphagia?
Read the detailed description
Introduction: Dysphagia is a common complication in acute stroke patients. Although there are treatment options, healing takes time. Managing this process in the safest way is important for the physical and mental health of the patient.
Purpose: This study aimed to evaluate the effectiveness of a safe nutrition program applied to acute stroke patients with dysphagia.
- Conditions
- DYSPHAGIA
- Being tested
- SAFE NUTRITION PROGRAM
- Keywords
- DYSPHAGIA, STROKE
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFE NUTRITION PROGRAMBehavioural
Safe nutrition program:
patient education, caregiver training, behavioral swallowing intervention, position, oral care, swallowing exercises, swallowing assessment
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | safe nutrition arm Receives: Behavioral: SAFE NUTRITION PROGRAM |
| control arm | No intervention | control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of dysphagia
aspiration pneumonia
Measured: 3 months
Complications of dysphagia
Dehydration
Measured: 3 months
Complications of dysphagia
malnutrition
Measured: 3 months
Secondary outcomes (2)
Stroke-Specific Quality of Life Scale (SS-QOL)
A high score on the scale indicates a high quality of life, A low score indicates a low quality of life. (Max:235; min: 48)
Measured: 3 months
Swallowing Anxiety Scale (YKÖ)
Getting a high score from the scale indicates that the individual's swallowing anxiety symptoms increase. (max: 40; min: 0)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start5 Oct 2020
- Primary completion15 Aug 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DYSPHAGIAStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- non-randomized controlled
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha Tülek, Istanbul University - Cerrahpasa
- Investigators
- Aysel Cavusoglu, Principal investigator, Istanbul Universitesi-CerrahpasaZeliha Tulek, Study director, Istanbul Universitesi-Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269575
- Sponsor's protocol ID
- Dysphagia
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT06269575
- Acronym / sponsor ID
- Dysphagia
- Conditions
- DYSPHAGIA
- Keywords
- DYSPHAGIA, STROKE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 21 Feb 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.
It was planned in a quasi-experimental design with a non-randomized control group. The study was planned to be completed in three stages: control, preparation and intervention periods.
Question 1: Does a safe nutrition program prevent aspiration pneumonia, dehydration and malnutrition in acute stroke patients with dysphagia? Question 2: Is the safe nutrition program effective on addiction level, quality of life and depression in acute stroke patients with dysphagia? Question 3: Does a safe nutrition program shorten the hospital stay and NG tube duration in acute stroke patients with dysphagia?
Detailed description
Introduction: Dysphagia is a common complication in acute stroke patients. Although there are treatment options, healing takes time. Managing this process in the safest way is important for the physical and mental health of the patient.
Purpose: This study aimed to evaluate the effectiveness of a safe nutrition program applied to acute stroke patients with dysphagia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-randomized controlled
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: SAFE NUTRITION PROGRAMsafe nutrition arm |
| control arm | No intervention | –control arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute stroke patients
- 18 years and over
Key exclusion criteria (1 listed)
- those who do not want to be involved in the study
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 |
|---|---|---|
| SAFE NUTRITION PROGRAMSafe nutrition program: patient education, caregiver training, behavioral swallowing intervention, position, oral care, swallowing exercises, swallowing assessment | Behavioural | experimental |
Primary outcome
Complications of dysphagia
Time frame: 3 months
aspiration pneumonia
Complications of dysphagia
Time frame: 3 months
Dehydration
Complications of dysphagia
Time frame: 3 months
malnutrition
2 secondary outcomes
Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: 3 months
Swallowing Anxiety Scale (YKÖ)
Time frame: 3 months
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 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Aysel Cavusoglu principal investigator
Istanbul Universitesi-Cerrahpasa
Zeliha Tulek study director
Istanbul Universitesi-Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAFE NUTRITION PROGRAM in people with DYSPHAGIA, 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 2 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 Feb 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?
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?
Complications of dysphagia (time frame: 3 months). The study lists 3 primary outcomes in all. 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 21 Feb 2024.