NCT02286050

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

October 27, 2014

Last Update Submit

May 9, 2017

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Difference between baseline patient satisfaction and month 22

    Self-reported patient satisfaction will be measured with a newly developped questionnaire.

    month 22

Secondary Outcomes (5)

  • Difference between baseline adherence and month 22

    month 22

  • Difference between baseline self-efficacy and month 22

    month 22

  • Difference between baseline treatment burden and month 22

    month 22

  • Difference between baseline trust and month 22

    month 22

  • Difference between baseline information need and month 22

    month 22

Other Outcomes (1)

  • Difference between baseline QoL and month 22

    month 22

Study Arms (1)

CF Nursing Intervention

EXPERIMENTAL
Other: CF Nursing Program

Interventions

CF Nursing ProgramOTHER
CF Nursing Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cystic Fibrosis

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

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 Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2014

First Posted

November 7, 2014

Study Start

November 1, 2014

Primary Completion

February 1, 2017

Study Completion

April 1, 2017

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

CH(1)