Evaluation Of The Effectiveness Of Safe Nutrition Program... | NCT06269575

Studies
Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia

NCT06269575

Sponsor

Istanbul University - Cerrahpasa

Status

Completed

Last Update Posted

Feb 21, 2024Actual

Enrollment

78Actual

Phase

Not Applicable

Conditions

DYSPHAGIA

Interventions

SAFE NUTRITION PROGRAM

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2020Actual

Primary Completion Date

Aug 15, 2023Actual

Completion Date

Dec 15, 2023Actual

First Submitted Date

Jan 4, 2024

First Submission Date that Met QC Criteria

Feb 13, 2024

First Posted Date

Feb 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2024

Last Update Posted Date

Feb 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental	Experimental	safe nutrition arm	Behavioral: SAFE NUTRITION PROGRAM
control arm	No Intervention	control arm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAFE NUTRITION PROGRAM	Behavioral	Safe nutrition program: patient education, caregiver training, behavioral swallowing intervention, position, oral care, swallowing exercises, swallowing assessment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complications of dysphagia	aspiration pneumonia	3 months
Complications of dysphagia	Dehydration	3 months
Complications of dysphagia	malnutrition	3 months

Secondary Outcomes

Measure	Description	Time Frame
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)	3 months
Swallowing Anxiety Scale (YKÖ)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute stroke patients
18 years and over

Exclusion Criteria:

those who do not want to be involved in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aysel Cavusoglu	Istanbul Universitesi-Cerrahpasa	Principal Investigator
Zeliha Tulek	Istanbul Universitesi-Cerrahpasa	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Universitesi-Cerrahpasa		Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003680	Deglutition Disorders
D020521	Stroke

Ancestor Terms

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided