The BALANCE Study: A Study in Spain to Find Out Whether a Patient Support Program Helps People With Pulmonary Fibrosis Who Take Nintedanib

Not yet recruiting

• Conditions: Pulmonary Fibrosis

• Registration Number: NCT06912659
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Study First Posted: 2025-04-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Study Start: 2025-06-05
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 493

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient satisfaction with Patient Support Program (PSP) Balance Program at baseline using the Baker Questionnaire.	at Baseline	Baker Questionnaire: This questionnaire contains 18 items divided into four domains. related to general satisfaction, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published.; Items in both modules have a five-option numeric score that ranges from 1 "Not at all" to 5 "Extremely". Total Baker score ranges from 0 to 90, with higher numbers indicating a greater satisfaction. In this study the mean value will be include.

Secondary Outcome Measures

Name	Time	Method
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)	up to 12 months
Time from first dose to permanent discontinuation of nintedanib within 12-month follow-up.	up to 12 months
Absolute number of nintedanib dose interruptions.	up to 12 months
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.	up to 12 months	Baker Questionnaire: This questionnaire contains 18 items divided into four domains. related to general satisfaction, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published.; Items in both modules have a five-option numeric score that ranges from 1 "Not at all" to 5 "Extremely". Total Baker score ranges from 0 to 90, with higher numbers indicating a greater satisfaction. In this study the mean value will be include.
Patient satisfaction with PSP Balance Program at baseline, 6 and 12 months after the inclusion in the study using the Likert scale.	at baseline and up to 12 months	Likert scale: This questionnaire contains 8 items. related to satisfaction with PSP, the care provided by the professional, the time dedicated to the consultation and the relationship with the professional. There is no cut point published.; Items have a four-option numeric score that ranges from 1 "Not at all" to 4 "Extremely".
Health-Related Quality of Life (HRQoL) at baseline and 12-month follow-up using the L-PF Impacts Questionnaire.	at baseline and up to 12 months	Total score (from 0 to 100 points) and symptoms, impacts, dyspnea, cough and fatigue scores obtained in the L-PF Questionnaire at each visit; L-PF Impacts Questionnaire: This questionnaire contains 44 items divided into two modules. The Impacts module (21 items) assesses multiple aspects of the quality of life with a recall period of 1 week. The questionnaire was developed recently (before it was used in Idiopathic Pulmonary Fibrosis (IPF) patients only) and there is no cut point published. The Symptoms module yields three domain scores: 1) dyspnea, 2) cough and 3) fatigue as well as a total Symptoms score. Items in both modules (L-PF Impacts and L-PF Symptoms) have a five-option numeric score that ranges from 0 "Not at all" to 4 "Extremely". Total L-PF score ranges from 0 to 100, with higher numbers indicating a greater impairment.
Anxiety and depression scores in Hospital Anxiety and Depression Scale (HADS) Questionnaire at baseline and 12-month follow-up.	at baseline and up to 12 months	Total score (from 0 to 100 points) obtained in the HADS Questionnaire at each visit.; HADS Questionnaire: The Hospital Anxiety and Depression Scale-Spanish Version is a 14-item self-report screening scale for anxiety and depression in Spanish-speaking populations. HADS consists of a 7-item anxiety subscale and a 7-item depression subscale. Each item scores on a 4-point Likert scale.; Each item is scored on a scale of 0 = best to 3 = worst, which means that the maximum score for each subscale is 21. To interpret the results, the total sums of each subscale are considered separately. A score of 0 to 7 on any of the subscales is generally considered to be an absence of relevant disorder, 8 to 10 indicates the presence of borderline or borderline symptoms, and a score of 11 or higher suggests a significant presence of anxiety or depression.
Disease symptoms score in Living with Pulmonary Fibrosis (L-PF) Symptoms Questionnaire at baseline and 12 months follow-up.	at baseline and up to 12 months	Total score (from 0 to 100 points) obtained in the L-PF Questionnaire at each visit.; L-PF Symptoms Questionnaire: This questionnaire contains 44 items divided into two modules. The Symptoms module (23 items) rates shortness of breath, cough, and fatigue in the past 24 hours. The questionnaire was developed recently (before it was used in IPF patients only) and there is no cut point published.; Items in both modules (L-PF Impacts and L-PF Symptoms) have a five-option numeric score that ranges from 0 "Not at all" to 4 "Extremely". Total L-PF score ranges from 0 to 100, with higher numbers indicating a greater impairment.
Absolute number of visits to emergency service and hospitalization related to Interstitial Lung Disease (ILD) between baseline and 12-month follow-up.	up to 12 months