Cystic FibrosisNCT02286050
Effect of a Nursing Program for Patients With Cystic Fibrosis on Disease Management
A study testing CF Nursing Program in people with Cystic Fibrosis, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to evaluate the effect of a nursing program in patients with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- CF Nursing Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cystic Fibrosis
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- CF Nursing Program
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CF Nursing ProgramOther
| Study group | Role | What they receive |
|---|---|---|
| CF Nursing Intervention | Experimental | Not described Receives: Other: CF Nursing Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between baseline patient satisfaction and month 22
Self-reported patient satisfaction will be measured with a newly developped questionnaire.
Measured: month 22
Secondary outcomes (5)
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.
Measured: 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.
Measured: month 22
Difference between baseline treatment burden and month 22
Self-reported treatment burden will be measured wiht a subscale of the CFQ-R.
Measured: 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.
Measured: 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.
Measured: month 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286050
- Sponsor's protocol ID
- SNCTP000000179
- Status last verified
- May 2017
- First submitted
- 27 Oct 2014
- Last updated
- 10 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auswirkung Eines CF Nursing-Programms Auf Das Krankheitsmanagement Und Die Erfahrungen Der Behandlung Von Patientinnen Und Patienten
- ClinicalTrials.gov ID
- NCT02286050
- Acronym / sponsor ID
- SNCTP000000179
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF Nursing Intervention | Experimental | Other: CF Nursing Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cystic Fibrosis
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CF Nursing Program | Other | CF Nursing Intervention |
Primary outcome
Difference between baseline patient satisfaction and month 22
Time frame: month 22
Self-reported patient satisfaction will be measured with a newly developped questionnaire.
5 secondary outcomes
Difference between baseline adherence and month 22
Time frame: month 22
Difference between baseline self-efficacy and month 22
Time frame: month 22
Difference between baseline treatment burden and month 22
Time frame: month 22
Difference between baseline trust and month 22
Time frame: month 22
Difference between baseline information need and month 22
Time frame: month 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CF Nursing Program in people with Cystic Fibrosis, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between baseline patient satisfaction and month 22 (time frame: month 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.