Adults with chronic obstructive pulmonary disease (COPD) or their caregivers. Respiratory COPD
Conditions
Interventions
This trial will consist of a mixed-methods approach and recruitment for each stage will be separate. Suitable participants will be identified. Once a participant has provided informed voluntary writte
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients: a. =18 years b. Stable COPD, confirmed on spirometry, as having a forced expiratory volume in 1 s (FEV1) post-bronchodilation of <80% and a predicted ratio of FEV1 to forced vital capacity of 0.70 c. Patients with MRC dyspnoea score =2 d. Able to read Marathi or Hindi e. Signed informed consent 2. Caregivers providing care and support to adults living with COPD.
Exclusion criteria
Exclusion criteria: 1. Co-morbidities or significant cardiovascular, hepatic, renal, neurological, orthopedic, neoplastic diseases that may hamper the participation of the patient and outcome of the program 2. Recent major surgery =1 month before enrolment 3. Pregnancy 4. Active pulmonary tuberculosis 5. Severe cognitive impairment such as dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of a digital self-management app intervention for people living with COPD in India. Measured by collecting data captured through the app and pre- and post-intervention FGDs between baseline and 8 weeks. The measurements to determine feasibility will be: 1. Number of participants identified, approached, consented, randomised and completed 2. Performance of participants – completion rate, perceived usefulness, burden etc. 3. Record of patient login, accessibility and adherence 4. App analytics including app usage -frequency, no. of views to read knowledge information, exercise information, video seen, incomplete use and drop-outs etc. 5. Insights on need, demand, usefulness of digital technology/app in COPD healthcare 6. Insights on their user-friendliness with smart phones, perceptions about using app for chronic health 7. COPD Assessment Test (CAT) will be important to identify severity of symptoms 8. Borg scale 9. MRC dyspnoea scale to indicate the extent to which breathlessness affects their mobility 10. Monitoring of physical exercises through app 11. COPD grading and clinical history and medical examinations, conditions, practicality of delivering the intervention in the proposed setting 12. Serious adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the demand for a digital self-management App for people in India living with COPD This will be achieved by conducting pre- and post-intervention FGDs to assess patient insights on the need, demand, and usefulness of a digital self-management app for COPD patients. Further insights will also be sought from patients about the use of digital smartphone apps in the management of chronic health conditions, along with the practicality of delivering the intervention in the proposed setting. Measured at baseline and 8 weeks. 2. Determine the adaptability of the ‘SPACE for COPD’ content and Yoga to ensure it is culturally appropriate for a global audience and specifically for India through literature review and pre-intervention FGDs with patients at baseline. This will be achieved through Communications and correspondences with the research team and the app developers in order to develop well-defined and verified content for the app. 3. Acceptability of the app for people living with COPD in India assessed through post-intervention FGDs with patients and/or their caregivers at 8 weeks 4. Patient compliance/adherence to the exercise sessions will be analyzed via data collected from the app at 8 weeks. | — |
Countries
India
Contacts
Public ContactMark Orme
Outcome results
None listed