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Completed

NCT Number: NCT02110914

A Coaching Intervention to Young Adults With Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

coaching

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.

Other names: Life coaching

Primary outcomes

  1. Feasibility of the intervention

    Time frame: 12 months

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

Secondary outcomes

  1. Health Related Quality of Life

    Time frame: 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)

  2. Self-reported Adherence

    Time frame: 21 months

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

  3. Pharmacy Refill Histories

    Time frame: 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

  4. Self-efficacy

    Time frame: 21 month

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

  5. Clinical data

    Time frame: 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

Other outcomes

  1. The participants' experiences with and acceptability of the intervention

    Time frame: 12 month

    In depth interviews with participants from the intervention arm after their last coaching session

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2014
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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