Telemonitoring of Treatment Effects in Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD) (TEL-CTD-ILD)
Primary Purpose
Connective Tissue Disease-associated Interstitial Lung Disease, Interstitial Lung Disease, Connective Tissue Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Telemonitoring
Sponsored by
About this trial
This is an interventional other trial for Connective Tissue Disease-associated Interstitial Lung Disease focused on measuring Telemonitoring, Telemedicine, Interstitial lung disease, Connective Tissue Diseases, Treatment
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Department of Pneumology and Allergy, Medical University of LodzRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Telemonitoring group
Control group
Arm Description
3 months home-based telemonitoring
3 months standard care
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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).
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.
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.
For the telemonitoring arm, oxygen saturation (SpO2) expressed in percent
Oxygen saturation level (SpO2) will be measured by transdermal Pulse Oximeter.
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.
For the telemonitoring arm, systolic blood pressure (SBP) expressed in mmHg
Systolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer
For the telemonitoring arm, diastolic blood pressure (DBP) expressed in mmHg
Diastolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer
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.
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.
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04428957
Brief Title
Telemonitoring of Treatment Effects in Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
Acronym
TEL-CTD-ILD
Official Title
Telemonitoring as a Tool for the Assessment of Treatment Effects of Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lodz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Connective Tissue Disease-associated Interstitial Lung Disease, Interstitial Lung Disease, Connective Tissue Diseases
Keywords
Telemonitoring, Telemedicine, Interstitial lung disease, Connective Tissue Diseases, Treatment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telemonitoring group
Arm Type
Experimental
Arm Description
3 months home-based telemonitoring
Arm Title
Control group
Arm Type
No Intervention
Arm Description
3 months standard care
Intervention Type
Other
Intervention Name(s)
Telemonitoring
Intervention Description
Daily telemonitoring of heart rate (HR), blood pressure (BP), pulse oximetry (SpO2), spirometry (FVC), activity (accelerometry) and severity of cough and dyspnea
Primary Outcome Measure Information:
Title
Change from baseline health-related quality of life using EQ-5D-5L questionnaire at 3 months
Description
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.
Time Frame
at baseline, after 3 months
Title
Change from baseline health-related quality of life using St. George's Respiratory Questionnaire at 3 months
Description
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.
Time Frame
at baseline, after 3 months
Secondary Outcome Measure Information:
Title
Costs of health service utilization in Polish zloty
Description
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.
Time Frame
after 3 months, after 6 months
Title
Assessment of Dyspnea using Modified Medical Research Council (mMRC)
Description
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.
Time Frame
at baseline, after 3 months
Title
Assessment of fatigue using Fatigue Assessment Scale (FAS)
Description
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.
Time Frame
at baseline, after 3 months
Title
Assessment of patients' adherence to recommended medications using the Adherence Scale in Chronic Diseases (ASCD)
Description
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).
Time Frame
at baseline, after 3 months
Title
Change from baseline anxiety and depression symptoms as measured by HADS (Hospital Anxiety and Depression Scale)
Description
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.
Time Frame
at baseline, after 3 months
Title
Change from baseline depression as measured by PHQ-9
Description
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.
Time Frame
at baseline, after 3 months
Title
For the telemonitoring arm, oxygen saturation (SpO2) expressed in percent
Description
Oxygen saturation level (SpO2) will be measured by transdermal Pulse Oximeter.
Time Frame
twice a day day from baseline for 3 months
Title
For the telemonitoring arm, heart rate (HR) expressed in beats per minute (bpm)
Description
Heart rate home telemonitoring consisted of twice-daily patient self-measurement of heart rate with automated device.
Time Frame
twice a day day from baseline for 3 months
Title
For the telemonitoring arm, systolic blood pressure (SBP) expressed in mmHg
Description
Systolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer
Time Frame
twice a day day from baseline for 3 months
Title
For the telemonitoring arm, diastolic blood pressure (DBP) expressed in mmHg
Description
Diastolic BP will be assessed by home-based blood pressure telemonitoring using sphygmomanometer
Time Frame
twice a day day from baseline for 3 months
Title
For the telemonitoring arm, forced vital capacity (FVC) expressed in percent
Description
Lung function like forced vital capacity (FVC, %FVC) will be assessed using home spirometry.
Time Frame
twice a day day from baseline for 3 months
Title
For the telemonitoring arm, forced expiratory volume in 1st second (FEV1) expressed in percent
Description
Lung function like forced expiratory volume in 1 second (FEV1, %FEV1) will be assessed using home spirometry.
Time Frame
twice a day day from baseline for 3 months
Title
For the telemonitoring arm, patient's satisfaction assessed by developed telemonitoring satisfaction survey.
Description
Developed telemonitoring satisfaction survey will be used for the assessment of patient's satisfaction in 10 areas assessed using the 5-point Likert scale.
Time Frame
after 3 months
Title
For the telemonitoring arm, cough severity measured using 5-point Likert scale (range 0-4)
Description
A 5-point Likert scale will be used to measure cough severity
Time Frame
twice a day day from baseline for 3 months
Title
For the telemonitoring arm, dyspnea severity measured using a 5-point Likert scale (range 0-4)
Description
A 5-point Likert scale will be used to measure dyspnea severity
Time Frame
twice a day day from baseline for 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylwia Małysiak-Szpond, MSc
Phone
+48519515038
Email
sylwia.malysiak-szpond@stud.umed.lodz.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wojciech Piotrowski, Assoc. Prof.
Organizational Affiliation
Department of Pneumology and Allergy, Medical University of Lodz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pneumology and Allergy, Medical University of Lodz
City
Łódź
State/Province
Lodz Province
ZIP/Postal Code
90-153
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Mozga, MD
Email
maria.mozga@umed.lodz.pl
First Name & Middle Initial & Last Name & Degree
Wojciech Piotrowski, Assoc. Prof.
First Name & Middle Initial & Last Name & Degree
Joanna Miłkowska-Dymanowska, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telemonitoring of Treatment Effects in Connective Tissue Disease-associated Interstitial Lung Disease (TEL-CTD-ILD)
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