A Coaching Intervention to Young Adults With Cystic Fibrosis

NCT ID: NCT02110914

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-12-21

Brief Summary

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The treatment burden for patients with cystic fibrosis (CF) is significant and poor adherence has been well-documented. The investigators hypothesize that a coaching intervention will empower young adults with CF to manage their lives with CF and improve health-related quality of life (HRQoL). The main aim of the study is to establish the feasibility and acceptability of a life-coaching intervention.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Coaching

10 coaching sessions over a period of 6 - 9 months. The intervention is life coaching based on principles of the co-active coaching model.

Group Type EXPERIMENTAL

Coaching

Intervention Type BEHAVIORAL

Coaching is based on the principles of the Co-active coaching model and performed by a certified coach. At the first coaching session the coach and client will make an agreement about the format for subsequent coaching sessions. The first and the last coaching session will always be "face to face" at the hospital and last 1- 1½ hours. Intervening coaching sessions will be approximately 60 minutes by phone or face to face. In total, ten coaching sessions will be offered, one every 1-2 weeks early in the program and one every 2-4 weeks later in the process. The duration of the coaching intervention will be between 6 and 9 months.

Control

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Coaching

Coaching is based on the principles of the Co-active coaching model and performed by a certified coach. At the first coaching session the coach and client will make an agreement about the format for subsequent coaching sessions. The first and the last coaching session will always be "face to face" at the hospital and last 1- 1½ hours. Intervening coaching sessions will be approximately 60 minutes by phone or face to face. In total, ten coaching sessions will be offered, one every 1-2 weeks early in the program and one every 2-4 weeks later in the process. The duration of the coaching intervention will be between 6 and 9 months.

Intervention Type BEHAVIORAL

Other Intervention Names

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Life coaching

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with cystic fibrosis (CF), confirmed by clinical findings, identification of two disease-causing CF- mutations, and a positive sweat test
* Patient at the Copenhagen CF Centre

Exclusion Criteria

* Severe intellectual impairment or insufficient mastery of the Danish language, determined by incapacity to independently complete the questionnaires
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Karin Bæk Knudsen

PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laust H Mortensen, PhD

Role: STUDY_CHAIR

Department of Public Health at the University of Copenhagen

Locations

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Rigshospitalet

Copenhagen, Copenhagen, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-2013-FSP01

Identifier Type: -

Identifier Source: org_study_id

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