Connective Tissue Disease-associated Interstitial Lung DiseaseTEL-CTD-ILDNCT04428957
Telemonitoring of Treatment Effects in Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
A study testing Telemonitoring in people with Connective Tissue Disease-associated Interstitial Lung Disease and Interstitial Lung Disease, run by Medical University of Lodz at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Connective Tissue Disease-associated Interstitial Lung Disease, Interstitial Lung Disease, Connective Tissue Diseases
- What is being tested?
- Telemonitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 11 Feb 2020to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed interstitial lung disease with a small component of fibrous changes;
- Indications for systemic glucocorticoid therapy +/- immunosuppressant;
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Pneumology and Allergy, Medical University of Lodz
Lodz, Lodz Province, 90-153
Maria Mozga, MD, maria.mozga@umed.lodz.pl
Wojciech Piotrowski, Assoc. Prof.
About this study
Official title: Telemonitoring as a Tool for the Assessment of Treatment Effects of Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
- Impact of telemonitoring on quality of life (QoL) of patients with CTD-ILD
- Evaluation of health status of patients with connective tissue disease-associated interstitial lung disease (CTD-ILD) using telemonitoring and standard care.
- 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.
- Evaluation of cost-effectiveness of telemonitoring solutions in patients with CTD-ILD.
- Evaluation of telemedicine as a tool for assessing the safety of therapy
Read the detailed description
Interstitial lung disease (ILD) is one of the most serious pulmonary complications related to connective tissue diseases (CTDs), resulting in substantial morbidity and mortality. Interstitial lung disease is a common manifestation of different connective tissue diseases, such as scleroderma, rheumatoid arthritis (RA), Sjögren's syndrome, systemic lupus, dermatomyositis and others. Radiological and histopathological patterns are most often nonspecific interstitial pneumonia (NSIP), organizing pneumonia (OP), usual interstitial pneumonia (UIP) and lymphocytic interstitial pneumonia (LIP).
Current standard of care in progressive CTD associated ILD is low to medium dose of corticosteroids, frequently combined with immunosuppressive medication, depending on disease severity and local standards. However, based on clinical and radiological features, it is difficult to predict what will be the response to the treatment. Effectiveness of the treatment is assessed by functional tests and chest high resolution computed tomography (HRCT), performed usually after 3 months of therapy.
Project objective is to assess the possible benefits of using telemonitoring of functional and vital signs, symptoms and quality of life of patients with CTD-ILD in response to treatment.
In the trial patients diagnosed with CTD-ILD will be randomized to intervention group (telemonitoring) and the control group (traditional assessment). Patients from the study after initial training will perform daily spirometry (FVC), transdermal pulse oximetry, pulse and blood pressure measurements, activity measurement (accelerometry), and assessment of severity of cough and dyspnea. The additional questionnaires will also be used to assess the tolerability of treatment, quality of life and the occurrence of side effects. Telemonitoring will start 10 to 14 days before the start of treatment and will be carried out for 3 months of therapy. All patients (study and control group) will receive treatment in accordance with current treatment standards. During the 3-month observation period, visits to the center will take place at monthly intervals. In the case of treatment intolerance or deterioration of monitored parameters, patients will be evaluated at additional time points. All patients after the end of the 3-month follow-up will remain under the care of the Pulmonology Clinic and will be examined during regular visits every 3 months until the end of the 12-month follow-up period.
- Conditions
- Connective Tissue Disease-associated Interstitial Lung Disease, Interstitial Lung Disease, Connective Tissue Diseases
- Being tested
- Telemonitoring
- Keywords
- Telemonitoring, Telemedicine, Interstitial lung disease, Connective Tissue Diseases, Treatment
- Medical subject headings
- Lung Diseases, Interstitial, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringOther
Daily telemonitoring of heart rate (HR), blood pressure (BP), pulse oximetry (SpO2), spirometry (FVC), activity (accelerometry) and severity of cough and dyspnea
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring group | Experimental | 3 months home-based telemonitoring Receives: Other: Telemonitoring |
| Control group | No intervention | 3 months standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at baseline, after 3 months
Secondary outcomes (15)
Costs of health service utilization in Polish zloty
Mean costs in telemonitoring and control group will be estimated. Healthcare utilization will be assessed through the number of emergency department, hospital or outpatient clinic visits, medications and adverse events treatments. Resource use categories will be monetarily valued using unit cost and multiplied with the collected amount of resource use. Mean costs in Polish zloty per group will be calculated.
Measured: after 3 months, after 6 months
Assessment of Dyspnea using Modified Medical Research Council (mMRC)
The Modified Medical Research Council Dyspnea (mMRC) scale will be used to determine functional impairment due to dyspnea. It is a five-level rating scale consisting of just five items containing statements about the impact of dyspnea on the patients' daily activities performance. Higher scores indicate a greater impact of dyspnea on the patients' daily activities performance.
Measured: at baseline, after 3 months
Assessment of fatigue using Fatigue Assessment Scale (FAS)
Fatigue Assessment Scale (FAS) will be used for assessment of fatigue status. The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
Measured: at baseline, after 3 months
Assessment of patients' adherence to recommended medications using the Adherence Scale in Chronic Diseases (ASCD)
The Adherence Scale in Chronic Diseases is a self-reported questionnaire with 8 items and with proposed 5 sets of answers. The total score in the Adherence Scale in Chronic Diseases ranges from 0 to 32 points. Three levels of adherence were considered (low: scores of 0 to 20; medium 21 to 25; high > 26).
Measured: at baseline, after 3 months
Change from baseline anxiety and depression symptoms as measured by HADS (Hospital Anxiety and Depression Scale)
The Hospital Depression and Anxiety Index (HADS) is a 14-item survey with scores ranging from 0 to 21 and with higher scores indicating greater depression and anxiety.
Measured: at baseline, after 3 months
Change from baseline depression as measured by PHQ-9
The Patient Health Questionnaire (PHQ-9) is a 10-item survey with scores ranging from 1 to 27 and with higher scores indicating greater levels of depression.
Measured: at baseline, after 3 months
For the telemonitoring arm, oxygen saturation (SpO2) expressed in percent
Oxygen saturation level (SpO2) will be measured by transdermal Pulse Oximeter.
Measured: twice a day day from baseline for 3 months
For the telemonitoring arm, heart rate (HR) expressed in beats per minute (bpm)
Heart rate home telemonitoring consisted of twice-daily patient self-measurement of heart rate with automated device.
Measured: twice a day day from baseline for 3 months
For the telemonitoring arm, systolic blood pressure (SBP) expressed in mmHg
Systolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer
Measured: twice a day day from baseline for 3 months
For the telemonitoring arm, diastolic blood pressure (DBP) expressed in mmHg
Diastolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer
Measured: twice a day day from baseline for 3 months
For the telemonitoring arm, forced vital capacity (FVC) expressed in percent
Lung function like forced vital capacity (FVC, %FVC) will be assessed using home spirometry.
Measured: twice a day day from baseline for 3 months
For the telemonitoring arm, forced expiratory volume in 1st second (FEV1) expressed in percent
Lung function like forced expiratory volume in 1 second (FEV1, ％FEV1) will be assessed using home spirometry.
Measured: twice a day day from baseline for 3 months
For the telemonitoring arm, patient's satisfaction assessed by developed telemonitoring satisfaction survey.
Developed telemonitoring satisfaction survey will be used for the assessment of patient's satisfaction in 10 areas assessed using the 5-point Likert scale.
Measured: after 3 months
For the telemonitoring arm, cough severity measured using 5-point Likert scale (range 0-4)
A 5-point Likert scale will be used to measure cough severity
Measured: twice a day day from baseline for 3 months
For the telemonitoring arm, dyspnea severity measured using a 5-point Likert scale (range 0-4)
A 5-point Likert scale will be used to measure dyspnea severity
Measured: twice a day day from baseline for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start11 Feb 2020
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Connective Tissue Disease-associated Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wojciech Piotrowski, Assoc. Prof., Principal investigator, Department of Pneumology and Allergy, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428957
- Sponsor's protocol ID
- RNN/50/20/KE
- Other IDs
- 0047/DW/2018
- Acronym
- TEL-CTD-ILD
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36574413
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring as a Tool for the Assessment of Treatment Effects of Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
- ClinicalTrials.gov ID
- NCT04428957
- Acronym / sponsor ID
- TEL-CTD-ILD / RNN/50/20/KE
- Conditions
- Connective Tissue Disease-associated Interstitial Lung Disease, Interstitial Lung Disease, Connective Tissue Diseases
- Keywords
- Telemonitoring, Telemedicine, Interstitial lung disease, Connective Tissue Diseases, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Impact of telemonitoring on quality of life (QoL) of patients with CTD-ILD
- Evaluation of health status of patients with connective tissue disease-associated interstitial lung disease (CTD-ILD) using telemonitoring and standard care.
- 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.
- Evaluation of cost-effectiveness of telemonitoring solutions in patients with CTD-ILD.
- Evaluation of telemedicine as a tool for assessing the safety of therapy
Detailed description
Interstitial lung disease (ILD) is one of the most serious pulmonary complications related to connective tissue diseases (CTDs), resulting in substantial morbidity and mortality. Interstitial lung disease is a common manifestation of different connective tissue diseases, such as scleroderma, rheumatoid arthritis (RA), Sjögren's syndrome, systemic lupus, dermatomyositis and others. Radiological and histopathological patterns are most often nonspecific interstitial pneumonia (NSIP), organizing pneumonia (OP), usual interstitial pneumonia (UIP) and lymphocytic interstitial pneumonia (LIP).
Current standard of care in progressive CTD associated ILD is low to medium dose of corticosteroids, frequently combined with immunosuppressive medication, depending on disease severity and local standards. However, based on clinical and radiological features, it is difficult to predict what will be the response to the treatment. Effectiveness of the treatment is assessed by functional tests and chest high resolution computed tomography (HRCT), performed usually after 3 months of therapy.
Project objective is to assess the possible benefits of using telemonitoring of functional and vital signs, symptoms and quality of life of patients with CTD-ILD in response to treatment.
In the trial patients diagnosed with CTD-ILD will be randomized to intervention group (telemonitoring) and the control group (traditional assessment). Patients from the study after initial training will perform daily spirometry (FVC), transdermal pulse oximetry, pulse and blood pressure measurements, activity measurement (accelerometry), and assessment of severity of cough and dyspnea. The additional questionnaires will also be used to assess the tolerability of treatment, quality of life and the occurrence of side effects. Telemonitoring will start 10 to 14 days before the start of treatment and will be carried out for 3 months of therapy. All patients (study and control group) will receive treatment in accordance with current treatment standards. During the 3-month observation period, visits to the center will take place at monthly intervals. In the case of treatment intolerance or deterioration of monitored parameters, patients will be evaluated at additional time points. All patients after the end of the 3-month follow-up will remain under the care of the Pulmonology Clinic and will be examined during regular visits every 3 months until the end of the 12-month follow-up period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring group | Experimental | Other: Telemonitoring3 months home-based telemonitoring |
| Control group | No intervention | –3 months standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed interstitial lung disease with a small component of fibrous changes;
- Indications for systemic glucocorticoid therapy +/- immunosuppressant;
- 18 years and older
- Informed consent to participate in the study;
- Effective contraception;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemonitoringDaily telemonitoring of heart rate (HR), blood pressure (BP), pulse oximetry (SpO2), spirometry (FVC), activity (accelerometry) and severity of cough and dyspnea | Other | Telemonitoring group |
Primary outcome
Change from baseline health-related quality of life using EQ-5D-5L questionnaire at 3 months
Time frame: at baseline, after 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.
Change from baseline health-related quality of life using St. George's Respiratory Questionnaire at 3 months
Time frame: at baseline, after 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.
15 secondary outcomes
Costs of health service utilization in Polish zloty
Time frame: after 3 months, after 6 months
Assessment of Dyspnea using Modified Medical Research Council (mMRC)
Time frame: at baseline, after 3 months
Assessment of fatigue using Fatigue Assessment Scale (FAS)
Time frame: at baseline, after 3 months
Assessment of patients' adherence to recommended medications using the Adherence Scale in Chronic Diseases (ASCD)
Time frame: at baseline, after 3 months
Change from baseline anxiety and depression symptoms as measured by HADS (Hospital Anxiety and Depression Scale)
Time frame: at baseline, after 3 months
Change from baseline depression as measured by PHQ-9
Time frame: at baseline, after 3 months
For the telemonitoring arm, oxygen saturation (SpO2) expressed in percent
Time frame: twice a day day from baseline for 3 months
For the telemonitoring arm, heart rate (HR) expressed in beats per minute (bpm)
Time frame: twice a day day from baseline for 3 months
For the telemonitoring arm, systolic blood pressure (SBP) expressed in mmHg
Time frame: twice a day day from baseline for 3 months
For the telemonitoring arm, diastolic blood pressure (DBP) expressed in mmHg
Time frame: twice a day day from baseline for 3 months
For the telemonitoring arm, forced vital capacity (FVC) expressed in percent
Time frame: twice a day day from baseline for 3 months
For the telemonitoring arm, forced expiratory volume in 1st second (FEV1) expressed in percent
Time frame: twice a day day from baseline for 3 months
For the telemonitoring arm, patient's satisfaction assessed by developed telemonitoring satisfaction survey.
Time frame: after 3 months
For the telemonitoring arm, cough severity measured using 5-point Likert scale (range 0-4)
Time frame: twice a day day from baseline for 3 months
For the telemonitoring arm, dyspnea severity measured using a 5-point Likert scale (range 0-4)
Time frame: twice a day day from baseline for 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 36574413Malysiak-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wojciech Piotrowski, Assoc. Prof. principal investigator
Department of Pneumology and Allergy, Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring in people with Connective Tissue Disease-associated Interstitial Lung Disease and Interstitial Lung Disease, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylwia Małysiak-Szpond, MSc (+48519515038, sylwia.malysiak-szpond@stud.umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline health-related quality of life using EQ-5D-5L questionnaire at 3 months (time frame: at baseline, after 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04428957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.