NCT06269575

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

January 4, 2024

Last Update Submit

February 13, 2024

Conditions

DYSPHAGIA

Keywords

DYSPHAGIASTROKE

Outcome Measures

Primary Outcomes (3)

  • Complications of dysphagia

    aspiration pneumonia

    3 months

  • Complications of dysphagia

    Dehydration

    3 months

  • Complications of dysphagia

    malnutrition

    3 months

Secondary Outcomes (2)

  • Stroke-Specific Quality of Life Scale (SS-QOL)

    3 months

  • Swallowing Anxiety Scale (YKÖ)

    3 months

Study Arms (2)

experimental

EXPERIMENTAL

safe nutrition arm

Behavioral: SAFE NUTRITION PROGRAM

control arm

NO INTERVENTION

control arm

Interventions

SAFE NUTRITION PROGRAMBEHAVIORAL

Safe nutrition program: patient education, caregiver training, behavioral swallowing intervention, position, oral care, swallowing exercises, swallowing assessment

experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute stroke patients
  • years and over

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Universitesi-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Deglutition DisordersStroke

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Aysel Cavusoglu

    Istanbul Universitesi-Cerrahpasa

    PRINCIPAL INVESTIGATOR

  • Zeliha Tulek

    Istanbul Universitesi-Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: non-randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 4, 2024

First Posted

February 21, 2024

Study Start

October 5, 2020

Primary Completion

August 15, 2023

Study Completion

December 15, 2023

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)