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

February 13, 2024 updated by: Zeliha Tülek, Istanbul University - Cerrahpasa (IUC)

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • İstanbul Üniversitesi-Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • acute stroke patients
  • 18 years and over

Exclusion Criteria:

  • those who do not want to be involved in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental
safe nutrition arm
Behavioral: SAFE NUTRITION PROGRAM

Safe nutrition program:

patient education, caregiver training, behavioral swallowing intervention, position, oral care, swallowing exercises, swallowing assessment
No Intervention: control arm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke-Specific Quality of Life Scale (SS-QOL)
Time Frame: 3 months
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)
Time Frame: 3 months
Getting a high score from the scale indicates that the individual's swallowing anxiety symptoms increase. (max: 40; min: 0)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Aysel Cavusoglu, İstanbul Üniversitesi-Cerrahpaşa
  • Study Director: Zeliha TÜLEK, İstanbul Üniversitesi-Cerrahpaşa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dysphagia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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