MyTatva mobile app plus Routine doctor advice plus Pharmacotherapy
The study duration will be around 12 weeks from randomization until end of study.
Comparator Agent
Routine doctor advice plus Pharmacotherapy
The study duration will be around 12 weeks from randomization until end of study.
Inclusion Criteria
Age From
40.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Other
Method of Concealment
Centralized
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
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)
Change from baseline to Week 12
Secondary Outcome
Outcome
TimePoints
Improvement in lung function capacity – FEV1, FVC
Improvement in serum protein
Improvement in BMI
Change from baseline to Week 12
Target Sample Size
Total Sample Size="100" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "104" Final Enrollment numbers achieved (India)="104"
Phase of Trial
Post Marketing Surveillance
Date of First Enrollment (India)
08/12/2023
Date of Study Completion (India)
23/01/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="4" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Objective:
To evaluate the impact of lifestyle modification with diet and exercise delivered by MyTatva application in management of patients with chronic obstructive pulmonary disease (COPD).
Study Population:
In total, 100 patients will be included into trial, they will be randomized into either of the two arms with parallel group assignment in a 1:1 ratio.
Study Arms:
Intervention Arm- MyTatva mobile app + Routine doctor advice + Pharmacotherapy
Comparator Arm- Routine doctor advice + Pharmacotherapy
Clinical Evaluations :
The patients will be randomized to either of the below mentioned
two arms:
Intervention Arm (MyTatva application)
ï‚· All the details of the patient will be documented in the MyTatva App using Lifestyle Questionnaire form at screening/baseline/randomization.
 Quality of life improvement (St. George’s Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) questionnaire score)
ï‚· The eligible patients meeting inclusion and exclusion criteria will receive customized diet and exercise plan based on the grading of the Lifestyle Questionnaire answered by them.
ï‚· The patients will receive regular recommendations or a standard of care provided through the investigator.
Comparator Arm
ï‚· All the details of the patient will be documented using the Lifestyle Questionnaire form at screening/baseline/randomization
 Quality of life improvement (St. George’s Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) questionnaire score).
ï‚· The patients will receive regular recommendations or a standard of care provided through the Investigator. 6-minute walk test (6MWT) will be performed at site on baseline, every 4 weeks and 12 weeks for both the arms.
 Daily (Baseline to 12 weeks)
Steps count*, Calories burned of the calorie intake*, Sleep duration, heart rate*, sedentary time tracking*, SPO2*, FEV1** and FVC** will be examined on daily basis. AQI, humidity, Location temperature will be examine daily for intervention arm only.
*These activities will be a part of intervention arm only.
**FEV1 and FVC will be performed at site for comparator arm on baseline, every 4 weeks and 12 weeks visit.
 Every 2 weeks (±2 days)
ï‚· Physical activity intervention by exercise coach and diet intervention by diet coach will be examined every 2 weeks for intervention arm only. This activity will be carried out over the phone.
ï‚· Adverse Event Assessment.
 Every 4 weeks (±2 days/during interim visits)
ï‚· Vital signs (blood pressure, pulse rate, respiratory rate and body temperature), physical examination, 6MWT, FEV1, FVC and Body weight will be measure every 4 weeks.
ï‚· Adverse Event Assessment.
 At end of study (12 weeks (±4 days)) / Early termination visit
ï‚· Vital signs, Physical examination, Laboratory test (i.e. Serum protein & Vitamin D), Step Counts*, Sleep duration, Calories burned of the calorie intake*, Physical Activity Intervention by Exercise Coach*, 6 Minute walk test, Diet Intervention by Diet Coach*, Heart Rate*, Sedentary time tracking*, SpO2*, FEV1, FVC, Body weight, Body mass index (BMI), Patient satisfaction for MyTatva App (mHealth App Usability Questionnaire (MAUQ) )*
ï‚· Quality of life improvement will be evaluated by CAT questionnaire score and St. George Respiratory Questionnaire.
ï‚· Adverse Event Assessment
*These activities will be a part of intervention arm only.
Every 4 weeks (±2 days) will be during interim visits i.e. at 4 weeks and 8 weeks.