Patient-centered Outcomes Research in Interstitial Lung Disease: An Official American Thoracic Society Research Statement.
Kerri I Aronson, Sonye K Danoff, Anne-Marie Russell...
https://pubmed.ncbi.nlm.nih.gov/34283696Actively Recruiting
Led by Aveiro University · Updated on 2024-04-30
150
Participants Needed
1
Research Sites
30 weeks
Total Duration
A
Aveiro University
Lead Sponsor
F
Fundação para a Ciência e a Tecnologia
Collaborating Sponsor
Researchers are studying people with interstitial lung diseases (ILD) to understand how their ability to perform daily activities, called functional status, changes over time. The study aims to explore what causes declines in functional status, evaluate tools that measure this ability, gather patients' perspectives through interviews, track progression over two years, and develop a combined index to predict mortality. ILD causes lung inflammation and scarring, leading to breathing difficulties and muscle weakness that affect daily functioning and quality of life. This observational study includes several tasks: first, validating functional status measurement tools with assessments at baseline and one week later; second, conducting interviews to capture patient experiences; third, tracking functional status and health outcomes every six months for two years aligned with routine appointments; and finally, using collected data to create a multidimensional index predicting mortality. Assessments involve physical tests, questionnaires, interviews, and clinical data collection. Participants will be involved in about 90-minute sessions for each assessment at designated hospitals. Researchers will collect data on muscle strength, physical activity, symptoms, quality of life, hospitalizations, and mortality. The primary outcome is measured by the Short Physical Performance Battery at multiple time points. Safety and health status are monitored throughout, with data analyzed to understand functional decline and its impact in ILD over time.
CONDITIONS
LetS Get fUnctional! FuNctional Status in pEople With intersTitial Lung Disease
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for informed consent and eligibility confirmation
Duration - 1 day
Participants complete baseline functional status assessments and interviews to characterize their current health and functional abilities.
1 baseline visit (in-person) coinciding with routine appointment
Duration - 1 day
Participants complete a second functional status assessment 7 days after baseline to validate measures.
1 follow-up visit (in-person) approximately 7 days after baseline
Duration - 24 months
Participants are observed over 24 months with repeated assessments of functional status and health outcomes during routine appointments.
4 visits (in-person) at 6, 12, 18, and 24 months aligned with routine care
Total: 1 location
1
University of Aveiro
Aveiro, Portugal, 3810-193
Actively Recruiting
A
Alda S. Marques, PhD
O
Odete M. Alves, MSc
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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