Back to resultsEffect of a Nursing Program for Patients With Cystic Fibrosis on Disease Management
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
CF Nursing Program
Sponsored by
About this trial
This is an interventional supportive care trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Cystic Fibrosis
Exclusion Criteria:
- None
Sites / Locations
- University Hospital Zurich
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CF Nursing Intervention
Arm Description
Outcomes
Primary Outcome Measures
Difference between baseline patient satisfaction and month 22
Self-reported patient satisfaction will be measured with a newly developped questionnaire.
Secondary Outcome Measures
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.
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.
Difference between baseline treatment burden and month 22
Self-reported treatment burden will be measured wiht a subscale of the CFQ-R.
Difference between baseline trust and month 22
Self-reported trust will be measured with the short version of the Wake Forest Trust Scale.
Difference between baseline information need and month 22
Information needs will be assessed with a subscale of the PICKER-questionnaire for patients with CF.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02286050
Brief Title
Effect of a Nursing Program for Patients With Cystic Fibrosis on Disease Management
Official Title
Auswirkung Eines CF Nursing-Programms Auf Das Krankheitsmanagement Und Die Erfahrungen Der Behandlung Von Patientinnen Und Patienten
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of a nursing program in patients with cystic fibrosis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CF Nursing Intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
CF Nursing Program
Primary Outcome Measure Information:
Title
Difference between baseline patient satisfaction and month 22
Description
Self-reported patient satisfaction will be measured with a newly developped questionnaire.
Time Frame
month 22
Secondary Outcome Measure Information:
Title
Difference between baseline adherence and month 22
Description
Self-reported adherence to therapy will be measured with the Medication Adherence Report Scale (MARS) and a newly developped questionnaire.
Time Frame
month 22
Title
Difference between baseline self-efficacy and month 22
Description
Self-reported self-efficacy to master the the therapeutic regimen will be measured with a newly developped questionnaire.
Time Frame
month 22
Title
Difference between baseline treatment burden and month 22
Description
Self-reported treatment burden will be measured wiht a subscale of the CFQ-R.
Time Frame
month 22
Title
Difference between baseline trust and month 22
Description
Self-reported trust will be measured with the short version of the Wake Forest Trust Scale.
Time Frame
month 22
Title
Difference between baseline information need and month 22
Description
Information needs will be assessed with a subscale of the PICKER-questionnaire for patients with CF.
Time Frame
month 22
Other Pre-specified Outcome Measures:
Title
Difference between baseline QoL and month 22
Description
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).
Time Frame
month 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cystic Fibrosis
Exclusion Criteria:
None
Facility Information:
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effect of a Nursing Program for Patients With Cystic Fibrosis on Disease Management
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