Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation Health Condition 2: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 3: J459- Other and unspecified asthma Health Condition 4: J439- Emphysema, unspecified Health Condition 5: J454- Moderate persistent asthma Health Condition 6: J455- Severe persistent asthma Health Condition 7: J418- Mixed simple and mucopurulent chronic bronchitis
Conditions
Interventions
Intervention1: Respeck (worn using adhesive tape over the anterolateral chest) and Smartwatch worn over wrist alongwith smartphone for data recording and display: Consenting patients shall be instruct
both shall be synced with a smartphone for data transfer via Bluetooth. On smartphone display, patients shall be instructed to monitor vitals like SpO2, heart rate, and daily respiratory and activity
Sponsors
Principal Investigator Pawan Tiwari
Eligibility
Inclusion criteria
Inclusion criteria: a. Severe asthma and COPD-E patients presenting with exacerbation requiring systemic steroids b. Severe asthma and COPD (GOLD E) patients being discharged after recovering from exacerbation c. Severe asthma and COPD (GOLD E) patients presenting to OPD with stable symptoms d. Willing to participate and attend OPD quarterly for the subsequent four visits, i.e., a total duration of one year e. Written informed consent.
Exclusion criteria
Exclusion criteria: a. Severe asthma and COPD patients requiring hospitalisation (till stabilisation/recovery) b. Inability to follow up as per protocol c. not giving written informed consent d. Patients with a life expectancy of less than four weeks e. Not willing to wear sensors f. Patients unable/unwilling to follow up for one year due to feasibility issues g. Living far off to be supplied sensors at home more than 50 km from AIIMS New Delhi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Early identification of treatment failure at day 28 (for patients with acute exacerbation of severe obstructive airway disease 2. Correlation of Quality-of-Life Questionnaire (SGRQ) and disease control scores with wearable-derived physical activity scores (in stable OAD patients) Timepoint: upto day 28 from inclusion in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment failure and hospitalisation rates at one month in compliant (more than 80% usable data) vs non-compliant (less than 40% usable data) patientsTimepoint: 28 days;To evaluate personalised monitoring of respiratory parameters recovering from OAD exacerbationTimepoint: 28 days; To correlate symptoms, disease control, lung functions, six-minute walk test and quality of life of severe OAD patients with physiologic parameters measured using the wearable deviceTimepoint: 28 days (in patients recruited during exacerbation) 14 days during each cycle (in stable patients);;To develop personalised analytical models to predict deterioration in the condition of severe adult obstructive disease patientsTimepoint: End of enrollment (1 year); To translate the personalised models into new care pathways to manage the condition of severe adult obstructive airway disease patientsTimepoint: End of enrollment (1 year); To evaluate the feasibility of wearable device usage based on total wearing time and percentage of usable data providedTimepoint: end of enrollment (1 year); Any adverse effects of wearable device useTimepoint: end of enrollment (1 year) | — |
Countries
India
Contacts
Public ContactPawan Tiwari
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed