Implementation of Home Monitoring in Patients With Pulmonary Fibrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
The objective of this study is to evaluate the impact of structurally replacing half of the outpatient clinic visits for patients with pulmonary fibrosis by home monitoring and video consultations on patient self-management and health(care) outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A multidisciplinary ILD team diagnosis of pulmonary fibrosis according to ATS/ERS/JRS/ALAT guidelines;
Adults (=/>18 years).
Disqualifiers
Patients who are not able to speak, read and/or write in Dutch;
Patients with no access to the internet;
Patients with a life expectancy of less than 1 year as determined by the treating healthcare provider;
Patients who are or have been using a home monitoring program for PF.
Trial design
Design model
Parallel
Treatments tested in this trial
Home monitoring care
Combination productPatients in the home monitoring group will receive a home spirometer, pulse oximetry meter, and access to a smartphone or tablet app, where they can perform home based measurements weekly and complete PROMs. Furthermore, this app includes disease specific information and allows for direct communication with the hospital via eConsultation. In the home monitoring group, half of the outpatient clinic visits will alternately be replaced by remote visits via video consultation.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Hospital-based careNo intervention 0 interventions
Group B: Home monitoring careExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient self-management
Delta score of the Patient Activation Measure (PAM) questionnaire. The PAM is a 13-item survey assessing levels of patient activation in terms of managing their own health and healthcare. Total score ranges are 0-100, with higher scores indicating greater patient activation.
Time frame
Baseline to 12 monthsSecondary outcomes
1
Patient self-management
The Patient Activation Measure (PAM) questionnaire is a 13-item survey assessing levels of patient activation in terms of managing their own health and healthcare. Total score ranges are 0-100, with higher scores indicating greater patient activation.
Time frame
Baseline2
Patient self-management
Delta score of the Patient Activation Measure (PAM) questionnaire. The PAM is a 13-item survey assessing levels of patient activation in terms of managing their own health and healthcare. Total score ranges are 0-100, with higher scores indicating greater patient activation.
Time frame
Baseline to 6 months3
Living with Pulmonary Fibrosis (L-PF) questionnaire
The Living with Pulmonary Fibrosis (L-PF) questionnaire is developed to assess symptoms and HRQOL in patients with Pulmonary Fibrosis. It consists of 44 items divided into two modules: symptoms (23 items) and impacts (21 items). The symptom module assesses shortness of breath, cough and fatigue. The impacts module assesses multiple aspects of HRQOL on a five-option numeric rating score. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment.
Time frame
Baseline4
Living with Pulmonary Fibrosis (L-PF) questionnaire
Delta scores of all domains of the Living with Pulmonary Fibrosis (L-PF) questionnaire will be assessed. The L-PF questionnaire is developed to assess symptoms and HRQOL in patients with Pulmonary Fibrosis. It consists of 44 items divided into two modules: symptoms (23 items) and impacts (21 items). The symptom module assesses shortness of breath, cough and fatigue. The impacts module assesses multiple aspects of HRQOL on a five-option numeric rating score. Overall scores range from 0 to 100, with higher numbers indicating a greater impairment.
Time frame
Baseline to 6 monthsOther outcomes
1
Cost-effectiveness and cost-utility analyses
The costs, cost-effectiveness and cost-utility analyses will be conducted from a healthcare system and societal perspective.
Time frame
Baseline to 12 months2
Healthcare professional- and patient satisfaction
Healthcare providers and patients will be asked about their satisfaction and experiences on home monitoring.
Time frame
12 months3
Time to detection of a decline of 10% in in-hospital versus home-based FVC
Time frame
Baseline to 12 months4
Travel movements
Explorative evaluation of the effect of home monitoring on travel movements.
Time frame
Baseline to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands
Collaborator
Leiden University Medical Center, LUMC, Leiden, The Netherlands
Collaborator
UMC Utrecht, Utrecht, the Netherlands
Collaborator
Rijnstate, Arnhem, the Netherlands
Collaborator
Catharina, Eindhoven, the Netherlands
Collaborator
MC Leeuwarden, Leeuwarden, the Netherlands
Collaborator
OLVG, Amsterdam, the Netherlands
Collaborator
Medical Center Haaglanden, The Hague, The Netherlands
Collaborator
Amphia, Breda, the Netherlands
Collaborator
St. Antonius Hospital
Collaborator
Source ClinicalTrials.gov