Summary of the administrative structure of the study
| Study title | Comparison of clinical effectiveness and cost-effectiveness of a remote monitoring programme vs usual care in interstitial lung disease (REMOTE-ILD) | |
| Trial registration number Date registered | www.clinicaltrials.gov NCT05662124; 22/12/2022 | |
| Protocol Version | v3.3 third July 2023 | |
| Funding | The study is funded by NIHR Invention for Innovation (i4i) programme | |
| Protocol Contributors | Dr Sarah Barth Dr Colin Edwards Rebecca Borton Dan Beever Dr Wendy Adams Prof Gisli Jenkins Dr Elena Pizzo Dr Iain Stewart Dr Melissa Wickremasinghe | ICHT, ICL patientMpower Ltd patientMpower Ltd Action for Pulmonary Fibrosis Action for Pulmonary Fibrosis ICL UCL ICL ICHT |
| Name and contact information for the trial sponsor | Research Governance and Integrity Team, Joint research office, Room 221, Medical School Building, St Mary’s Campus, Norfolk Place, London W2 1 PG rgit@imperial.ac.uk | |
| Role of sponsor | The study sponsor has overseen the design of the study and will have oversight of the trial. The sponsor has ensured that the trial protocol, Patient Information Sheet (PIS), Informed Consent Form (ICF), GP letter and submitted supporting documents have been approved by the MHRA and a main Research Ethics Committee (REC), prior to any patient recruitment taking place. This study will be conducted in compliance with the protocol approved by the REC and according to GCP standards and UK Clinical Trials Regulation. Data ownership rights will lie with the institution. Our expectation is that after data analysis, information from this study will be widely disseminated in the medical and scientific community. | |
| Study start date | 1st March 2023 | |
| Planned completion of study | 31st March 2025 |