A Coaching Intervention to Young Adults With Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Coaching

• Registration Number: NCT02110914
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Study Start: 2014-05
• Primary Completion: 2016-12-21
• Study Completion: 2016-12-21
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coaching	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	12 months	Willingness of eligible participants to be recruited and randomized, adherence to the intervention and attrition rates

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life	Up to 21 months	The primary effect outcome is change in health-related quality of life (HRQoL), with special focus on the two domains: Social and Emotional functioning on the Cystic Fibrosis Questionnaire-Revised (CFQ-R).; For the intervention group HRQoL is measured at baseline, midway (after 5 coaching sessions), post intervention (after 10 coaching sessions) and at follow up (12 months post intervention) For the control group HRQoL is measured at baseline, midway (after 4 months), post intervention (after 9 months) and at follow up (12 months post intervention)
Self-reported Adherence	21 months	Morisky Medication Adherence Scale (MMAS-8), questionnaires are completed at baseline, and 4, 9 and 21 months after baseline
Pharmacy Refill Histories	up to 1 year	Data from the pharmacy database will be collected for two four- month periods: four months prior to the intervention and four months at the end of the intervention. The last four months will be two months prior to end of study and two months after for the intervention group, and seven to eleven month after baseline for the control group
Self-efficacy	21 month	General Self-Efficacy Scale (GSE), questionnaires are completed at baseline, and 4, 9 and 21 months after baseline
Clinical data	21 months	Lung function test (spirometry, FEV1), Body Mass Index (BMI) and Hemoglobin A1C (HbA1C), Data will be collected from the medical chart at baseline, and 4, 9 and 21 months after baseline

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark