An interventional study of Group Monitoring and Control Group in ILD and COPD, sponsored by University of Sao Paulo General Hospital. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Supportive care
Assess quality of life of patients using prolonged oxygen therapy
Adult participants of both sexes with COPD and PID, prolonged oxygen use, will be evaluated after being informed about the study, agreeing and signing the informed consent form. Participants will be randomized to a control group and a group monitored for 90 days. The monitored group will receive a wearable device to monitor vital signs of heart rate and oxygen saturation and the control group will receive a pulse oximeter. Both groups will be monitored through the cell phone application.
University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
After randomization, participants in the GM group will receive the Venu® SQ monitor (Garmin). All participants will receive guidance on how to use the ODI in the educational class, and at the end they will receive specific instructions for use of the devices they will receive (wearable monitor or pulse oximeter). After the first visit, GM participants will be contacted biweekly by telephone to obtain information on their clinical progress, where they will be asked about the number of exacerbations, respiratory symptoms, medication adherence, time of O2 use, and dyspnea symptoms (mMRC). Likewise, monthly contact will be made to obtain information on health factors associated with quality of life (K-BILD), CAT and EQ-5D-5L, and symptoms of anxiety and depression (HADS).
Behavioral: Group Monitoring
For the GC, contact will only be monthly to obtain all the information mentioned above in addition to the HR and SpO2 measurements taken on the day of the telephone application.
Behavioral: Control Group
In the intervention group (IG), participants receive a HR and SPO2 monitor watch and a pulse oximeter and will be monitored every 15 days by a nurse to check for non-adherence and/or technical failure, and/or exacerbations, and monthly to apply questionnaires.
In the control group (CG), participants receive only a pulse oximeter and will be monitored monthly by a nurse to administer the questionnaires.
Health-related quality of life (HRQOL): assessed using the EQ-5D-5L Questionnaire
The EQ-5D-5L questionnaire is a preference-based measure of HRQL with one question for each of five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses provided allow for 243 unique health states or can be converted into EQ-5D indices and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a score ranging from 0 (the worst possible health state) to 100 (the best possible health state).
Time frame: Change from baseline in 30 days over 90 days
Clinical Management: The COPD Assessment Test™ (CAT) is a specific questionnaire for COPD that assesses the impact of disease symptoms on quality of life factors in chronic obstructive pulmonary disease.
It consists of eight items related to the health condition and is applied and validated worldwide in several scales. The maximum score for the test is 40 points, and the questions cover the following symptoms: cough, phlegm production, chest pressure, shortness of breath, activities of daily living, psychological aspects, sleep and mood. Each question has six options (0-5), and the lower the score, the better the health condition. Time Frame: Change from baseline in 30 days over 90 days
Time frame: Change from baseline in 30 days over 90 days
Changes related to quality of life factors in interstitial lung disease - King's Brief Interstitial Lung Disease (K-BILD)
The King's Brief Interstitial Lung Disease (K-BILD) questionnaire is a health status questionnaire developed and validated specifically for patients with ILD. It consists of 15 items that measure health status in the last two weeks in three domains (symptoms, resistance, mental health status and dyspnea on exertion), and is easy to administer and understand by patients. Its classification can range from 0 to 100, with a higher score indicating a higher quality of life, and variations of 5 units are already considered clinically significant.
Time frame: Change from baseline in 30 days over 90 days
Change in psychosocial symptoms
Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADs), which consists of 14 items divided into 2 subscales (7 for anxiety and 7 for depression). Each item is scored from 0 to 3, with a maximum score of 21 points for each subscale. A score greater than 8/9 on each subscale suggests a diagnosis of anxiety and/or depression.
Time frame: Change from baseline in 30 days over 90 days
Change in dyspnea
Dyspnea scale: modified Medical Research Council (mMRC). The mMRC is a unidirectional 0- to 4-point scale whose questions closely correspond to daily activities that provoke dyspnea.
Time frame: Change from baseline in 30 days over 90 days
Adherence
Evaluated according to the data included in the application and responses to questionnaires.
Time frame: Baseline
Exarcebations
Assessed through changes or alterations in vital signs of heart rate and/or oxygen saturation through the wearable
Time frame: Baseline
Função pulmonar
Lung volumes will be assessed by spirometry
Time frame: Baseline
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University of Sao Paulo General Hospital