A Coaching Intervention to Young Adults With Cystic Fibrosis

Study Overview
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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.

Official Title
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Coach to Cope. Coaching Young Adults With Cystic Fibrosis - a Feasibility Study

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Coaching


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coaching<br>10 coaching sessions over a period of 6 - 9 months. The intervention is life coaching based on principles of the co-active coaching model. | Behavioral: Coaching<br>* 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.<br>* Other names: Life coaching;|
| No Intervention: Control<br>Standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the intervention | Willingness of eligible participants to be recruited and randomized, adherence to the intervention and attrition rates | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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 | up to 1 year | 
| Self-efficacy | General Self-Efficacy Scale (GSE), questionnaires are completed at baseline, and 4, 9 and 21 months after baseline | 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 | 21 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coaching, Feasibility study, Adherence, Health related quality of life