NCT03420235

Brief Summary

In this study it will be investigate whether a home monitoring program improves disease-specific health-related quality of life (HRQOL) for patients with idiopathic pulmonary fibrosis (IPF) through appropriate medication use and subsequently results in better objective and subjective outcomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

January 9, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2019

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

December 20, 2017

Last Update Submit

January 29, 2020

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

quality of lifeeHealthpatient-reported outcomeshome spirometrycost-effectivenesshome monitoring

Outcome Measures

Primary Outcomes (1)

  • Difference in the change in total score of King's brief Interstitial Lung Disease Health Status (K-BILD) questionnaire between the home monitoring group and the standard care group

    Change in HRQOL assessed by the K-BILD, between control group and home monitoring group at the end of the study. The K-BILD is a 15-item self-administered questionnaire on a 7-point response scale. It has three domains: breathlessness and activities, psychological and chest symptoms.The domain and total score ranges are 0-100, with the higher scores corresponding with better HRQL.

    24 weeks after inclusion

Secondary Outcomes (16)

  • Difference in the change in total score of King's brief Interstitial Lung Disease Health Status (K-BILD) questionnaire between the home monitoring group and the standard care group

    12 weeks after inclusion

  • Patient-reported outcome (PRO) scores (GRC)

    12 weeks after inclusion

  • Patient-reported outcome (PRO) scores (EQ5D)

    12 weeks after inclusion

  • Patient-reported outcome (PRO) scores (HADS)

    12 weeks after inclusion

  • Patient-reported outcome (PRO) scores (HADS)

    24 weeks after inclusion

  • +11 more secondary outcomes

Other Outcomes (13)

  • Home monitoring values of FVC compared to in hospital values of lung function

    12 weeks after inclusion

  • Home monitoring values of FVC compared to in hospital values of lung function

    24 weeks after inclusion

  • Correlation between FVC measurements and K-BILD

    12 weeks after inclusion

  • +10 more other outcomes

Study Arms (2)

Control group

NO INTERVENTION

Control group will receive standard care alone.

Home monitoring group

EXPERIMENTAL

Intervention will consist of a home monitoring program added to standard care.

Other: Home monitoring program

Interventions

Home monitoring programOTHER

The home monitoring program consists of 1) the use of an interactive internet tool to coach patients and enhance self-management 2) home-based pulmonary function testing with a handheld spirometer and 3) recording of patient-reported outcomes (PROs).

Home monitoring group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with a diagnosis of IPF according to the ATS 2011 criteria and about to start on anti-fibrotic treatment (either nintedanib or pirfenidone)

You may not qualify if:

  • Not able to speak, read or write in Dutch
  • No access to internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 CE, Netherlands

Location

Related Publications (2)

  • Moor CC, Mostard RLM, Grutters JC, Bresser P, Aerts JGJV, Dirksen CD, Kimman ML, Wijsenbeek MS. Patient expectations, experiences and satisfaction with nintedanib and pirfenidone in idiopathic pulmonary fibrosis: a quantitative study. Respir Res. 2020 Jul 23;21(1):196. doi: 10.1186/s12931-020-01458-1.

    PMID: 32703201DERIVED

  • Moor CC, Mostard RLM, Grutters JC, Bresser P, Aerts JGJV, Chavannes NH, Wijsenbeek MS. Home Monitoring in Patients with Idiopathic Pulmonary Fibrosis. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2020 Aug 1;202(3):393-401. doi: 10.1164/rccm.202002-0328OC.

    PMID: 32325005DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marlies Wijsenbeek, MD PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a prospective randomized clinical multi-center study to evaluate the effect of home monitoring on disease-specific HRQOL, (appropriate) medication use and other patient-relevant outcomes in patients with IPF treated with anti-fibrotic drugs. Patients with IPF about to start on anti-fibrotic medication will be randomly assigned to receive either the home monitoring program integrated with standard care or standard care alone after informed consent. Patient will be stratified for study center and medication.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. M.S. Wijsenbeek, pulmonologist, Principal Investigator

Study Record Dates

First Submitted

December 20, 2017

First Posted

February 5, 2018

Study Start

January 9, 2018

Primary Completion

August 26, 2019

Study Completion

August 26, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

NL(1)