NCT06112717

Brief Summary

The present study evaluates the effect of nursing care based on the Self-Care Deficit Nursing Theory on the knowledge and skills related to self-care among adolescents with Cystic Fibrosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 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

February 14, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
Last Updated

November 2, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

October 29, 2023

Last Update Submit

November 1, 2023

Conditions

Keywords

Cystic FibrosisAdolescenceSelf-care

Outcome Measures

Primary Outcomes (1)

  • The change in self care knowledge and skills of adolescents with Cystic Fibrosis

    The change in self-care knowledge and skills of adolescents at the end of the research after the applied nursing interventions.

    18 weeks(4.5 months) after first enrollment of patient.

Study Arms (2)

Nursing Care

EXPERIMENTAL

Seven home visit was made to adolescent in the intervention group. In the first and last visits only self-care knowledge and skills of adolescents were evaluated. In the 2.,3.,4.,5. and 6. home visits they received supportive-educational individualised nursing care based on Orem's Self Care Deficit Nursing Theory. The applied nursing interventions varied based on the individual needs and the level of assistance required by each adolescent. Each home visit lasted 30-60 minutes. Adolescents were given an educational booklet containing information about self-care in cystic fibrosis.

Other: Supportive-Educative Nursing Care

Control Group

NO INTERVENTION

Adolescents in the control group received no intervention by the researcher.

Interventions

Adolescents in the intervention group were received Supportive-Educative Nursing Care based on Orem's Self Care Deficit Nursing Theory

Nursing Care

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of Cystic Fibrosis determined by a positive sweat test and/or the presence of two Cystic Fibrosis mutations,
  • Aged between 12 and 18 years
  • Living in the same Ankara

You may not qualify if:

  • Adolescents with mental health issues
  • Adolescents with an atypical form of Cystic Fibrosis (characterized by an absence of symptoms and no medication requirement)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, 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 Officials

  • Hicran Çavuşoğlu, Professor

    Head of Pediatric Nursing Department, Faculty of Nursing, Hacettepe University, Turkey

    STUDY DIRECTOR
  • Deniz Doğru, Professor

    Pediatric Pulmonology Department, Faculty of Medicine, Hacettepe University, Turkey

    STUDY DIRECTOR
  • Tuğçe TORUN, PhD

    Pediatric Nursing Department, Faculty of Nursing, Hacettepe University, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There are 2 group in the study. Intervention Group and Control Group. The control group received no intervention by principal researcher.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Research Assistant

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 1, 2023

Study Start

February 14, 2019

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

November 2, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations