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

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

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

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: CF Nursing Program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cystic Fibrosis

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CF Nursing Intervention	Other: CF Nursing Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between baseline patient satisfaction and month 22	Self-reported patient satisfaction will be measured with a newly developped questionnaire.	month 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Difference between baseline treatment burden and month 22	Self-reported treatment burden will be measured wiht a subscale of the CFQ-R.	month 22
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 7, 2014

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: SNCTP000000179