NCT05963503

Brief Summary

The purpose of this study investigation of relationship between health literacy and physical activity, anxiety and depression, adherence to airway clearance techniques in adult patients with cystic fibrosis.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

July 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

July 19, 2023

Last Update Submit

February 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Health Literacy

    Health literacy will be evaluated with Health Literacy Scale. This scale total score ranges from 25-125 and lower scores show that lower health literacy.

    5 minutes

Secondary Outcomes (3)

  • Anxiety and Depression

    5 minutes

  • Physical Activity

    3 minutes

  • Adherence to Airway Clearance Tecniques

    1 minute

Study Arms (2)

Cystic Fibrosis

Inclusion Criteria: have a confirmed diagnosis of CF stable clinical condition 18-65 ages volunteering to participate Exclusion Criteria: having a serious comorbidity that limits mobilization or participation in physical activity being illiterate having cognitive problems being pregnant incomplete answers to surveys

Other: Assessments

Controls

Inclusion Criteria: 18-65 ages volunteering to participate Exclusion Criteria: having any cardiopulmonary disease having cognitive problems being illiterate

Other: Assessments

Interventions

Health literacy Anxiety and depression Physical activity Adherence to airway clearance techniques

ControlsCystic Fibrosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cystic fibrosis and healthy participants between 18-65 years old.

You may qualify if:

  • be between the ages of 18-65 volunteering to participate

You may not qualify if:

  • having any cardiopulmonary disease having cognitive problems being illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Naciye Vardar Yağlı

    Hacettepe University

    STUDY DIRECTOR
  • Ebru Damadoğlu

    Hacettepe University

    STUDY CHAIR
  • Oğuz Karcıoğlu

    Hacettepe University

    STUDY CHAIR
  • Aydan Aslı Aksel Uylar

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aydan Aslı Aksel Uylar

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 27, 2023

Study Start

August 15, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations