We are designing a clinical trial to examine the effectiveness of pulmonary rehabilitation in a cohort of patients with alpha-1 antitrypsin related COPD. We would like to use a mobile app to monitor exacerbations over the course of a 12 week intervention. Exacerbations are notoriously difficult to monitor. We are considering using the EXACT Pro tool but experience has shown that completion of daily paper diaries by patients is problematic and the data generated of poor quality.
Any suggestions or advice, greatly appreciated!
Hi Eoin,
Would suggest an app for COPD like cVitals.
For further details do visit.
https://www.focuscura.com/en/cvitals-telemoitoring/cvitals-copd
Many thanks Shahid. I downloaded the app there now. Looks quite good. Have you used it before yourself?
The Clinical Trials Transformation Initiative is about to complete a project on novel endpoints in clinical trials using mobile technology and are also conducting a project on how related device issues. We would recommend that you first identify what your endpoint is (by talking to patients and other stakeholders) and then look for the technology to support it not looking for the app first and then using that as an endpoint. Here is info on our project https://www.ctti-clinicaltrials.org/projects/novel-endpoints we also have a project regarding mobile devices and I have outlined our draft approach for device selection.
- Define clinical need
- Define how you want to measure desired outcome(s)
- Review potential device options that can measure desired outcome(s)
- Vetting implementing partners; exploring their capabilities (vs. core competencies)
- Considering Bring Your Own Device (BYOD) or study provides device
- Conduct internal assessments of proposed devices
Ping me if you would like more info or if I can connect you to our project manager.
Pam
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