Effect of a Nursing Program for Patients With Cystic Fibrosis on Disease Management

Cystic Fibrosis Clinical Trial

Official title:

Auswirkung Eines CF Nursing-Programms Auf Das Krankheitsmanagement Und Die Erfahrungen Der Behandlung Von Patientinnen Und Patienten

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02286050
• Other study ID #: SNCTP000000179
• Status: Completed
• Phase: N/A
• First received: October 27, 2014
• Last updated: May 9, 2017
• Start date: November 2014
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of a nursing program in patients with cystic fibrosis.

Description:

All patients living with cystic fibrosis will be asked by questionnaire before (November 2014) and after (September 2016) the implementation of the program about their satisfaction with treatment, trust in the CF-Team, adherence, self-efficacy, treatment burden and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cystic Fibrosis

Exclusion Criteria:

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• CF Nursing Program

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference between baseline QoL and month 22	Self-reported QoL will be measured with the Cystic Fibrosis Questionnaire - revised (CFQ-R) and the VAS of the European Quality of Life Instrument - 5 dimensions (EQ-5D VAS).	month 22
Primary	Difference between baseline patient satisfaction and month 22	Self-reported patient satisfaction will be measured with a newly developped questionnaire.	month 22
Secondary	Difference between baseline adherence and month 22	Self-reported adherence to therapy will be measured with the Medication Adherence Report Scale (MARS) and a newly developped questionnaire.	month 22
Secondary	Difference between baseline self-efficacy and month 22	Self-reported self-efficacy to master the the therapeutic regimen will be measured with a newly developped questionnaire.	month 22
Secondary	Difference between baseline treatment burden and month 22	Self-reported treatment burden will be measured wiht a subscale of the CFQ-R.	month 22
Secondary	Difference between baseline trust and month 22	Self-reported trust will be measured with the short version of the Wake Forest Trust Scale.	month 22
Secondary	Difference between baseline information need and month 22	Information needs will be assessed with a subscale of the PICKER-questionnaire for patients with CF.	month 22