Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: MyTatva mobile app plus Routine doctor advice plus Pharmacotherapy
: The study duration will be around 12 weeks from randomization until end of study.
Control Intervention1: Routine do
Sponsors
Digicare Health Solutions Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or female patients >40 years of age with confirmed diagnosis of moderate to severe COPD as per GOLD guidelines with no exacerbations within last 12 months. 2. Patient having FEV1 = 40% and = 80% (without using bronchodilator) of the predictable value. 3. Patient is willing and able to provide written informed consent. 4. Patient is willing to comply with all study procedures and available for the duration of the study. 5. Patient with access to a smartphone with internet access. 6. Patient who will be able to use MyTatva App.
Exclusion criteria
Exclusion criteria: Subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Persistent COPD with history of hospitalization in the last 6 months and unstable in the last 2 months. 2. Unable to read, write, or understand English. 3. The patient is not able to participate the exercise training program due to physical, cognitive or safety reasons, as judged by investigator, e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations and planned surgical or other interventions disturbing the study intervention. 4. Patient who is pregnant or planning to become pregnant. 5. Concurrent participation in any other interventional clinical trial. 6. Presumed or confirmed COVID-19 diagnosis within 30 days prior to randomization. 7. Co-existing known malignancy. 8. Patient not willing to perform coaching as instructed. 9. Patient with interstitial lung disease. 10. Severe exacerbations in last one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life improvement (St. Georges Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) questionnaire score), Improvement in functional capacity Six-minute walk test (6MWT), Percentage of patients with adherence to diet, exercise and medication (using questionnaire) Timepoint: Change from baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in lung function capacity – FEV1, FVC Improvement in serum protein Improvement in BMI Timepoint: Change from baseline to Week 12 | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed