This trial is active, not recruiting.

Condition cystic fibrosis
Treatment coaching
Sponsor Rigshospitalet, Denmark
Collaborator Gilead Sciences
Start date May 2014
End date December 2016
Trial size 40 participants
Trial identifier NCT02110914, H-2-2013-FSP01


The treatment burden for patients with cystic fibrosis (CF) is significant and poor adherence has been well-documented. The investigators hypothesize that a health 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 Motivational Interviewing inspired coaching-intervention.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
10 coaching sessions over a period of 6 - 9 months. The intervention is classic coaching based on principles of motivational interviewing (MI).
coaching Motivational interviewing
Coaching is based on the principles of Motivational Interviewing (MI) and performed by a certified coach trained within (MI). 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, Skype/Face Time 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.
(No Intervention)
Standard care

Primary Outcomes

Health Related Quality of Life
time frame: Up to 21 months

Secondary Outcomes

Self-reported Adherence
time frame: 21 months
Pharmacy Refill Histories
time frame: up to 1 year
time frame: 21 month
Clinical data
time frame: 21 months

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

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

Additional Information

Official title Coach to Cope. A Motivational Interviewing Inspired Coaching Intervention for Young Adults With Cystic Fibrosis: A Randomized Controlled Feasibility Study
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.