NCT06289972

Brief Summary

The goal of this methodological study is to determine the reliability and validity of the The Breathlessness Beliefs Questionnaire Caregiver Version (BBQ-C) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2024

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

February 26, 2024

Last Update Submit

March 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The Breathlessness Beliefs Questionnaire (Caregiver Version) (BBQ-C)

    The BBQ-C will assess dysfunctional dyspnea beliefs in caregivers.The questionnaire has a minimum score of 11 and a maximum score of 55. As the total score increases, the belief in dysfunctional dyspnea increases.

    baseline, after 15 days

Secondary Outcomes (4)

  • Cystic Fibrosis Questionnaire Revised (CFQ-R) for parent version

    baseline, after 15 days

  • Parent Attitude Scale (PAS)

    baseline, after 15 days

  • Perceived Social Support Scale (PSS)

    baseline, after 15 days

  • Parent Attitude Scale

    baseline, after 15 days

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of the study will consist of parents of CF patients who come to the Pediatric Chest Diseases Outpatient Clinic of a private hospital for routine control. The sample will consist of parents who fulfill the inclusion and exclusion criteria and volunteer to participate in the study.

You may qualify if:

  • To be between 25-75 years old,
  • To be literate in Turkish,
  • Being a mother, father or other caregiver of a child,
  • Voluntarily agreeing to participate in the study,
  • Be taking care of the child for at least one year

You may not qualify if:

  • Having cognitive impairment at a level that prevents cooperation with the scales,
  • Not living in the same household with a child with cystic fibrosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haliç University

Istanbul, Eyup, 34060, Turkey (Türkiye)

Location

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 Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 4, 2024

Study Start

February 20, 2024

Primary Completion

July 11, 2024

Study Completion

July 11, 2024

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations