Clinical trial NCT06912659: The BALANCE Study: A Study in Spain to Find Out Whether a Patient Support Program Helps People With Pulmonary Fibrosis Who Take Nintedanib
Official title: Non-interventional Prospective Study in Patients With Pulmonary Fibrosis Treated With Nintedanib Participating in a Patient Support Program in Spain, to Describe Patient Satisfaction With the Program and to Monitor Quality of Life - BALANCE Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-04-06
Enrollment: 493
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will include patients with IPF and PPF (other than IPF) participating in the PSP Balance Program. The study duration will be from the start of the recruitment period (which will last approximately 6 months) to the last follow-up visit of the last patient (approximately 18 months of total study period). Patients will be followed-up at 6 months and at 12 months.

Brief summary: The aim of this study is to describe patients' satisfaction with Patient Support Program (Balance Program), Quality of Life and depression symptoms, dosing pattern, disease symptoms, adverse events and nintedanib discontinuation (both permanent and non-permanent) from study inclusion to 12 months of follow-up.


Eligibility criteria: Inclusion criteria

* Adults (≥18 years old at baseline).
* Patients included in the Patient Support Program (PSP) Balance Program.
* Ability to read and speak Spanish correctly according to the investigator criteria.
* Agree to participate and signing informed consent at baseline.

Exclusion criteria

- Suspicion or diagnosis of any relevant cognitive impairment at the discretion of the investigator.

Primary outcomes:
measure: Patient satisfaction with Patient Support Program (PSP) Balance Program at baseline using the Baker Questionnaire.
timeFrame: at Baseline
Secondary outcomes:
measure: 1. Change in the satisfaction with Patient Support Program (PSP) Balance Program at 6 and 12-month follow-up after inclusion in the study, using the Baker Questionnaire.
timeFrame: up to 12 months
measure: Patient satisfaction with PSP Balance Program at baseline, 6 and 12 months after the inclusion in the study using the Likert scale.
timeFrame: at baseline and up to 12 months
measure: Dosing pattern of nintedanib calculated as absolute number of doses taken correctly divided by all the doses prescribed in that period (6 and 12 months)
timeFrame: up to 12 months
measure: Time from first dose to permanent discontinuation of nintedanib within 12-month follow-up.
timeFrame: up to 12 months
measure: Absolute number of nintedanib dose interruptions.
timeFrame: up to 12 months
measure: Health-Related Quality of Life (HRQoL) at baseline and 12-month follow-up using the L-PF Impacts Questionnaire.
timeFrame: at baseline and up to 12 months
measure: Anxiety and depression scores in Hospital Anxiety and Depression Scale (HADS) Questionnaire at baseline and 12-month follow-up.
timeFrame: at baseline and up to 12 months
measure: Disease symptoms score in Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire at baseline and 12 months follow-up.
timeFrame: at baseline and up to 12 months
measure: Absolute number of visits to emergency service and hospitalization related to Interstitial Lung Disease (ILD) between baseline and 12-month follow-up.
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
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