A Prospective, Randomized Controlled Trial to Assess the Impact of MyTatva Application in Management of Chronic Obstructive Pulmonary Disease. - NI

Digicare Health Solutions Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•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.

•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.

发起方

Digicare Health Solutions Private Limited