Health Condition 1: A15- Respiratory tuberculosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ·5 years of age and older ·Patients suggestive of pulmonary tuberculosis ·Stated willingness to comply with all trial procedures and availability for the duration of the trial ·Informed consent must be obtained before testing; completed by the subject, parent or guardian, or an emancipated minor ·Successful cough submission after applying any necessary filters on the SaMD
Exclusion criteria
Exclusion criteria: ·Under 5 years of age ·Unable to produce a voluntary forced cough vocalization (FCV) ·Recent (within the last year) acute traumatic injury to the head, neck, throat, chest, abdomen, or trunk ·Patent tracheostomy stoma ·Recent (within the last year) chest/abdomen/trunk trauma or surgery, recent/persistent neurovascular injury or recent intracranial surgery ·Medical history of cribriform plate injury or cribriform plate surgery, diaphragmatic hernia, external beam neck/throat / maxillofacial radiation, phrenic nerve injury/palsy, radical neck/throat/maxillofacial surgery, vocal cord trauma or nodules ·Since persons with aphasia may have difficulty in producing an FCV-SDS in the time allotted by the app, this population also will be excluded from the current trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of the intervention being used.Timepoint: The outcomes will be assessed at the baseline and thereafter every month till six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| To ensure that the device is user friendly in accordance with REASSURED criteria from WHOTimepoint: At end of data collection | — |
Countries
India
Contacts
Dr RPGMC Tanda Kangra