A multi-site trial of specialist palliative care in cystic fibrosis

Not Applicable

• Conditions: Cystic fibrosis in adults; Nutritional, Metabolic, Endocrine; Cystic fibrosis

• Registration Number: ISRCTN53323164
• Lead Sponsor: Emory University

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36126995/ (added 27/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-09
• Last Update Posted: 27 March 2023
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

1. English-speaking
2. Age =18 years
3. Palliative needs, as indicated by the following criteria:
3.1. =1 moderate or severe symptom (captured by the Integrated Palliative Outcomes Scale [IPOS]); OR
3.2. Reduced QoL (as captured by the IPOS); OR
3.3. =2 hospitalizations in the preceding year

Exclusion Criteria

1. Post lung transplant
2. Patient does not receive primary CF care from the study site or intends to transfer primary CF care elsewhere over the next year
3. Received outpatient specialty palliative care within the past 12 months
4. Lack of reliable telephone or internet access
5. Active suicidal ideation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Patient quality of life, measured by FACIT-PAL at baseline and quarterly for 15 months (months 3, 6, 9, 12, 15)<br> 2. Caregiver quality of life, measured by PROMIS Global 10 at baseline and quarterly for 15 months (months 3, 6, 9, 12, 15)<br>