A Coaching Intervention to Young Adults With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Coaching
Sponsored by
About this trial
This is an interventional other trial for Cystic Fibrosis focused on measuring Feasibility study, Coaching, Health related quality of life, Adherence
Eligibility Criteria
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
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Coaching
Control
Arm Description
10 coaching sessions over a period of 6 - 9 months. The intervention is life coaching based on principles of the co-active coaching model.
Standard care
Outcomes
Primary Outcome Measures
Feasibility of the intervention
Willingness of eligible participants to be recruited and randomized, adherence to the intervention and attrition rates
Secondary Outcome Measures
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)
Self-reported Adherence
Morisky Medication Adherence Scale (MMAS-8), questionnaires are completed at baseline, and 4, 9 and 21 months after baseline
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
Self-efficacy
General Self-Efficacy Scale (GSE), questionnaires are completed at baseline, and 4, 9 and 21 months after baseline
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
Full Information
NCT ID
NCT02110914
First Posted
April 4, 2014
Last Updated
April 12, 2017
Sponsor
Rigshospitalet, Denmark
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02110914
Brief Title
A Coaching Intervention to Young Adults With Cystic Fibrosis
Official Title
Coach to Cope. Coaching Young Adults With Cystic Fibrosis - a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 21, 2016 (Actual)
Study Completion Date
December 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Feasibility study, Coaching, Health related quality of life, Adherence
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coaching
Arm Type
Experimental
Arm Description
10 coaching sessions over a period of 6 - 9 months. The intervention is life coaching based on principles of the co-active coaching model.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Coaching
Other Intervention Name(s)
Life coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the intervention
Description
Willingness of eligible participants to be recruited and randomized, adherence to the intervention and attrition rates
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
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
Title
Self-reported Adherence
Description
Morisky Medication Adherence Scale (MMAS-8), questionnaires are completed at baseline, and 4, 9 and 21 months after baseline
Time Frame
21 months
Title
Pharmacy Refill Histories
Description
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
Title
Self-efficacy
Description
General Self-Efficacy Scale (GSE), questionnaires are completed at baseline, and 4, 9 and 21 months after baseline
Time Frame
21 month
Title
Clinical data
Description
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
Time Frame
21 months
Other Pre-specified Outcome Measures:
Title
The participants' experiences with and acceptability of the intervention
Description
In depth interviews with participants from the intervention arm after their last coaching session
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laust H Mortensen, PhD
Organizational Affiliation
Department of Public Health at the University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
A Coaching Intervention to Young Adults With Cystic Fibrosis
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