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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The participants' experiences with and acceptability of the intervention | In depth interviews with participants from the intervention arm after their last coaching session | 12 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laust H Mortensen, PhD | Department of Public Health at the University of Copenhagen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
|
| 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 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |