NCT02110914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2016

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

2.6 years

First QC Date

April 4, 2014

Last Update Submit

April 12, 2017

Conditions

Cystic Fibrosis

Keywords

Feasibility studyCoachingHealth related quality of lifeAdherence

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the intervention

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

    12 months

Secondary Outcomes (5)

  • Health Related Quality of Life

    Up to 21 months

  • Self-reported Adherence

    21 months

  • Pharmacy Refill Histories

    up to 1 year

  • Self-efficacy

    21 month

  • Clinical data

    21 months

Other Outcomes (1)

  • The participants' experiences with and acceptability of the intervention

    12 month

Study Arms (2)

Coaching

EXPERIMENTAL

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

Control

NO INTERVENTION

Standard care

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.

Also known as: Life coaching
Coaching

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Severe intellectual impairment or insufficient mastery of the Danish language, determined by incapacity to independently complete the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Laust H Mortensen, PhD

    Department of Public Health at the University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 10, 2014

Study Start

May 1, 2014

Primary Completion

December 21, 2016

Study Completion

December 21, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

DK(1)