NCT03241615

Brief Summary

The aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

August 8, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2017

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

August 3, 2017

Last Update Submit

January 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dysphagia symptom severity

    Dysphagia symptom severity will be determined by an eating assessment tool.

    1 month

Secondary Outcomes (1)

  • Quality of life assessment

    1 month

Study Arms (1)

Neurogenic dysphagia

Patients with neurogenic dysphagia who will willing to participate in the study, being over the age of 18, normal cognitive function (\[24 points according to the Mini Mental State Examination), suffering from dysphagia at least one month, and having clinically stable neurological disease will be included. Dysphagia evaluation will be performed.

Other: Dysphagia evaluation

Interventions

Dysphagia evaluation is performed in a clinical setting by an eating assessment tool. Swallowing related quality of life is also assessed.

Neurogenic dysphagia

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have neurogenic dysphagia and willing to participate in the study, being over the age of 20, normal cognitive function (24 points according to the Mini Mental State Examination), and having clinically stable neurological disease will be included.

You may qualify if:

  • Willing to participate in the study
  • Being over the age of 20
  • Normal cognitive function
  • Suffering from dysphagia at least one month

You may not qualify if:

  • Being under the age of 20 and above 65 years.
  • Abnormal cognitive function
  • Clinically unstable neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacetttepe University

Ankara, 06100, Turkey (Türkiye)

Location

Study Officials

  • SELEN SEREL ARSLAN

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 7, 2017

Study Start

August 8, 2017

Primary Completion

September 8, 2017

Study Completion

September 8, 2017

Last Updated

January 3, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations