A Coaching Intervention to Young Adults With Cystic Fibrosis

Rigshospitalet, Denmark40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

CoachingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

Rigshospitalet

Copenhagen, Copenhagen, Denmark

Outcomes

Primary Outcomes

Feasibility of the intervention

Willingness of eligible participants to be recruited and randomized, adherence to the intervention and attrition rates

Time frame: 12 months

Secondary Outcomes

Health Related Quality of Life

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)

Time frame: Up to 21 months

Self-reported Adherence

Morisky Medication Adherence Scale (MMAS-8), questionnaires are completed at baseline, and 4, 9 and 21 months after baseline

Time frame: 21 months

Pharmacy Refill Histories

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

Time frame: up to 1 year

Self-efficacy

General Self-Efficacy Scale (GSE), questionnaires are completed at baseline, and 4, 9 and 21 months after baseline

Time frame: 21 month

Clinical data

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

Data from ClinicalTrials.gov

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