Telemonitoring of Treatment Effects in Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
TEL-CTD-ILD
Telemonitoring as a Tool for the Assessment of Treatment Effects of Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
2 other identifiers
interventional
60
1 country
1
Brief Summary
- 1.Impact of telemonitoring on quality of life (QoL) of patients with CTD-ILD
- 2.Evaluation of health status of patients with connective tissue disease-associated interstitial lung disease (CTD-ILD) using telemonitoring and standard care.
- 3.Assessment of treatment response patterns (full remission, partial remission, progression, no response) and evaluation of clinical prognostic factors (risk factors for poor response in patients with CTD-ILD.
- 4.Evaluation of cost-effectiveness of telemonitoring solutions in patients with CTD-ILD.
- 5.Evaluation of telemedicine as a tool for assessing the safety of therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
February 11, 2020
CompletedFirst Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedJune 11, 2020
April 1, 2020
2.1 years
April 8, 2020
June 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline health-related quality of life using EQ-5D-5L questionnaire at 3 months
The EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L) questionnaire will be used for the assessment of quality of life. The EQ-5D-5L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L is especially suited to cost effectiveness analyses.
at baseline, after 3 months
Change from baseline health-related quality of life using St. George's Respiratory Questionnaire at 3 months
St. George's Respiratory Questionnaire (SGRQ) will be used to assess health related quality-of-life. The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. SGRQ is survey with scores ranging from 0 to 100 and with higher scores indicating worse quality of life.
at baseline, after 3 months
Secondary Outcomes (15)
Costs of health service utilization in Polish zloty
after 3 months, after 6 months
Assessment of Dyspnea using Modified Medical Research Council (mMRC)
at baseline, after 3 months
Assessment of fatigue using Fatigue Assessment Scale (FAS)
at baseline, after 3 months
Assessment of patients' adherence to recommended medications using the Adherence Scale in Chronic Diseases (ASCD)
at baseline, after 3 months
Change from baseline anxiety and depression symptoms as measured by HADS (Hospital Anxiety and Depression Scale)
at baseline, after 3 months
- +10 more secondary outcomes
Study Arms (2)
Telemonitoring group
EXPERIMENTAL3 months home-based telemonitoring
Control group
NO INTERVENTION3 months standard care
Interventions
Daily telemonitoring of heart rate (HR), blood pressure (BP), pulse oximetry (SpO2), spirometry (FVC), activity (accelerometry) and severity of cough and dyspnea
Eligibility Criteria
You may qualify if:
- Newly diagnosed interstitial lung disease with a small component of fibrous changes;
- Indications for systemic glucocorticoid therapy +/- immunosuppressant;
- years and older
- Informed consent to participate in the study;
- Effective contraception;
- Result of the Mini Mental test ensuring the possibility of efficient operation of monitoring devices;
- Completed training in the operation of telemedicine equipment.
You may not qualify if:
- Evidence of irreversible interstitial fibrotic changes in lung HRCT;
- Pattern of definite or probable usual interstitial pneumonia (UIP) in the HRCT examination;
- Contraindications to glucocorticoid and immunosuppressive therapy (azathioprine or mycophenolate mofetil or cyclophosphamide or cyclosporine);
- Pregnancy and breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pneumology and Allergy, Medical University of Lodz
Lodz, Lodz Province, 90-153, Poland
Related Publications (1)
Malysiak-Szpond S, Mozga M, Miadlikowska E, Milkowska-Dymanowska J, Bialas AJ, Piotrowski WJ. Study protocol for connective tissue disease-associated interstitial lung disease trial (TEL-CTD-ILD): A randomized controlled trial of a home-based telemonitoring of treatment effects. PLoS One. 2022 Dec 27;17(12):e0278601. doi: 10.1371/journal.pone.0278601. eCollection 2022.
PMID: 36574413DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wojciech Piotrowski, Assoc. Prof.
Department of Pneumology and Allergy, Medical University of Lodz
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2020
First Posted
June 11, 2020
Study Start
February 11, 2020
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
June 11, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share