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| Name | Class |
|---|---|
| Carol Davila University of Medicine and Pharmacy | OTHER |
| University of Zurich | OTHER |
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The RMD-mILDer trial is a home monitoring strategy trial aiming to improve management of interstitial lung disease related to rheumatic diseases applying eHealth technology.
It is planned as a 2 arm 54 week multi-centre randomised controlled trial to assess outcome of home monitoring with bi-weekly serial forced vital capacity- and patient reported outcome-measurements compared to standard of care with fixed-interval hospital visits in adult patients with rheumatic disease associated interstitial lung diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Scheduled hospital visits every 6 months | |
| Home monitoring | Experimental | Home monitoring strategy with remote patient data observation twice a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A home monitoring strategy with event driven management | Diagnostic Test | Bi-weekly home monitoring with forced vital capacity (FVC), patient reported outcome measures (PROMs), at-home measures of blood oxygen levels (SpO2) during 1-minute-sit-to-stand test (1MSTS) and temperature with algorithm based risk evaluation of deterioration and infection and consecutive event driven management |
| Measure | Description | Time Frame |
|---|---|---|
| Assess whether home monitoring identifies disease progression earlier than monitoring by fixed-interval hospital visits. | Time from baseline to disease progression assessed as first forced vital capacity (FVC) ≥5% decline (assessed by hospital FVC measurements) or non-elective hospitalization due to respiratory cause. | 54 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate effects of home monitoring compared to fixed-interval hospital visits on change in FVC | Absolute change from baseline in FVC (mL) and absolute change from baseline in FVC (% predicted). | after 54 weeks |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on FVC decline >10% events. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported symptoms related to the rheumatic disease (RMD) | Change in visual analogue scale (VAS) on RMD from 0 - 10 with higher values indicating more symptoms | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported general well-being |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily V Langballe, MD | Contact | 0047 2307 0000 | emilylangballe@hotmail.com | |
| Peter M Andel, MD, Dr.med. | Contact | 0047 2307 0000 | pemian@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Anna-Maria Hoffmann-Vold, MD, PhD | Oslo University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | 0873 | Norway |
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| Label | URL |
|---|---|
| University homepage | View source |
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The individual patient data of this study will not be publicly available as they contain information that could compromise the privacy of research participants and may be subject to ongoing research as long as the research project is ongoing. The original data will be available from the corresponding authors of subsequent publications upon reasonable request, except where restricted by GDPR liabilities.
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international, multi-center, 2-arm, 54-week, randomized controlled trial
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Proportion of patients who experience at least one FVC decline >= 10% event from baseline |
| baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported respiratory symptoms | Change in "Living with pulmonary fibrosis score" (LPF) total score, as well as the subdomains physical health, emotional well-being, social impact, functionality and daily activities as well as cognitive function where lower values indicate quality of life | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed hospital visits on progressive pulmonary fibrosis events. | Proportion of patients who experience a progressive pulmonary fibrosis event defined as fibrosing ILD fulfilling ≥2 (out of 3) criteria (worsening respiratory symptoms, radiological progression, and physiological progression (absolute decline in FVC ≥ 5% predicted within 1 year follow up OR absolute decline in diffusion capacity for carbon monoxide (DLCO) ≥10% predicted within 1 year of follow up) occurring within the past year with no alternative explanation in a patient with ILD. | baseline to week 54 |
Change in VAS on the patients global health from 0 - 10 with higher values indicating more symptoms |
| baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported health related quality of life | Change in the EuroQol Eq-5D-5L questionnaire with the following domains: Mobility, self-care, usual activities, pain/discomfort, anxiety/depression. The score typically ranges from 0 (representing a health state equivalent to death) to 1 (representing perfect health). | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported disability to perform daily tasks and carry out basic activity | Change in Health Assessment Questionaire (HAQ) covering eight different domains: Dressing and grooming, arising, eating, walking, hygiene, reach, gripping and activities. The HAQ has 20 questions. The score reaches from 0 (no incapacity) to 3 (full incapacity) | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported pain, fatigue and dryness in included patients with interstitial lung disease (ILD) related to Sjøgrens disease (SjD-ILD) | Change in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) with a range of 0 - 10, with higher values indicating more symptoms. | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on the patient reported impact of the diseases in included patients with ILD related to systemic sclerosis | Change in EULAR Systemic Sclerosis Impact of Disease (ScleroID) questionnaire whereby higher counts on a scale from 0-100 would indicate more impact | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on Physician reported global health burden | Change in VAS on global health from 0 - 10 with higher values indicating a higher burden | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with rheumatoid arthritis associated ILD (RA-ILD) | Change in Disease Activity Score-28 (DAS28) | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with Sjøgrens disease associated ILD (SjD-ILD) | Change in EULAR Sjögren's syndrome disease activity index (ESSDAI) | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with inflammatory idiopathic myopathies including antisynthetasis syndromes on a visual analogue scales | Change in MDAAT / MYOACT (range 0-60) where higher values would indicate more disease activity | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with inflammatory idiopathic myopathies including antisynthetasis syndromes on a questionnaire based skale | Change in MDAAT / MITAX (range 0-63) where higher values would indicate more disease activity | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on the disease activity in patients with systemic sclerosis | Change in Revised European Scleroderma Trials and Research Group Activity Index (EUSTAR-AI) (range 0-10) where higher values would indicate more disease activity | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on change in DLCO | Absolute change from baseline in DLCO (SI) · Absolute change from baseline in DLCO (% predicted) | at week 54 |
| Assess effect of home monitoring compared to fixed-interval hospital visits on extent of pulmonary fibrosis on high resolution computed tomography (HRCT) | Change in extent of fibrosis as percentage of total lung parenchyma on HRCT | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on degree of patient reported disability that breathlessness poses on day-to-day activities | Change in "Modified Medical Research Council Dyspnoea Scale" (mMRC) with a range of 0-4 where higher values indicate more disability | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported dyspnea | Change on a visual analogue scale for dyspnea where higher values would indicate more symptoms | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported cough | Change on a visual analogue scale for cough where higher values would indicate more symptoms | baseline to week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on patient reported symptoms | Change on a visual analogue scale for fatigue where higher values would indicate more symptoms | baseline to week 54 |
| Estimate ability of home monitoring compared to fixed-interval hospital visits to detect afebrile episodes | Number of verified afebrile episodes | at week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on patient treatment satisfaction | Difference in "Client satisfaction questionnaire 8" (CSQ-8) scores (range 8-32 where higher values indicate a higher satisfaction) between the to arms | at week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on patient mental health parameters | Difference on the "Hosital Anxiety and Depression Scale" (HADS) with a range of 0-21 where higher scores would indicate more depression and axiety | at week 54 |
| Estimate the effects of home monitoring compared to fixed-interval hospital visits on identification of clinically significant Respiratory Tract Infections (csRTI) | Total number and proportion of severe csRTIs compared between the arms | at week 54 |
| Estimate the effects of home monitoring compared to fixed-interval hospital visits on length of antibiotic treatment due to clinically significant Respiratory Tract Infections (csRTI) | Days on antibiotic therapy for csRTIs compared between the arms | at week 54 |
| Estimate the effects of home monitoring compared to fixed-interval hospital visits on hospitalisation for clinically significant Respiratory Tract Infections (csRTI) | Days hospitalised for csRTIs compared between the arms | at week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on identification of acute exacerbations | Time to first acute exacerbation event | baseline to week 54 |
| Assess immunologic activity in the peripheral blood by immune cells and soluble markers of inflammation in patients followed with home monitoring or fixed-interval hospital visits | Assess content and change in peripheral blood markers derived from peripheral blood (as evaluated by sequencing techniques, proteomics and cellular phenotyping) | at baseline and at week 54 |
| Assess immunologic activity in nasal swabs by immune cells and soluble markers of inflammation in patients followed with home monitoring or fixed-interval hospital visits | Assess content and change in immune cells and soluble markers of inflammation in nasal swabs (as evaluated by sequencing techniques, proteomics and cellular phenotyping) | at baseline and at week 54 |
| Estimate effects of home monitoring compared to fixed-interval hospital visits on changes in immunosuppressive therapy | Proportion of participants subjected to increased immunosuppression | baseline to week 54 |
| Assess remission of non-ILD disease manifestations in patients followed with home monitoring or fixed-interval hospital visits | Proportion of participants in non-remission for non-ILD disease manifestations | at baseline and at week 54 |
| Assess the effect of reflux disease at baseline on ILD progression | Proportion of patients who experience ILD progression with reflux disease compared to no reflux disease | after 54 weeks |
| ID | Term |
|---|---|
| D003882 | Dermatomyositis |
| D001172 | Arthritis, Rheumatoid |
| D003240 | Connective Tissue Diseases |
| D017563 | Lung Diseases, Interstitial |
| D012216 | Rheumatic Diseases |
| D011658 | Pulmonary Fibrosis |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D017285 | Polymyositis |
| D009220 | Myositis |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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