EDC for frailty and healthy ageing clinical trials

Frailty and healthy ageing research does not have a single endpoint. Depending on the question, a study might track a frailty index or phenotype, physical performance (grip strength, gait speed, chair rise, balance tests, a timed walk), cognition, mood, falls, quality of life, medication burden, body composition or blood markers of ageing. Many of these are measured at a handful of visits spread across months or years, while others, such as activity, sleep and falls, are most informative when collected continuously or frequently between visits.

That mix puts three demands on the data system. First, site-measured values must be entered consistently: the same unit, the same number of trials, the same conventions across clinics. Typed numeric fields with ranges and edit checks do this better than free text or a spreadsheet. Second, participant-reported data and device data must be linked to the same participant record as the clinic data, not stored in three places. Third, the whole record must be defensible: ageing studies are often long, funded by grants or longevity-focused sponsors, and examined by reviewers who ask how the data were controlled.

Frailty studies are also long. A twelve-month intervention trial with quarterly visits generates many opportunities for protocol change, staff turnover and missing data. Visit windows, completion windows for questionnaires and a compliance view by site make slippage visible while there is still time to act. The longevity side of this field overlaps with EDC for longevity clinical trials; this page is specifically about frailty, function and ageing in older adults.

Participant burden decides retention. Keep questionnaires short, avoid asking the same thing twice and use skip logic so a person who reports no falls is not walked through a falls questionnaire. Because participants answer through a link in their own phone browser, there is nothing to install and no account to forget; where a participant prefers it, staff can help them complete a task at the clinic. For design choices about phone-based collection, see BYOD ePRO without an app download and patient diary software.

Consent deserves particular care. Where a participant has reduced capacity, local rules and your ethics committee determine who may consent on their behalf; Capture supports a Legally Authorized Representative signature and an optional witness co-signature, and the signed form exports as a PDF with the signature data, timestamps and audit trail. The investigator countersigns with password re-authentication, and the document is fully executed only after that countersignature. See eConsent software for clinical trials for the full flow. Where a study needs a caregiver to report on the participant's behalf, a proxy ePRO template shows the structure; adapt the wording for your population and get ethics approval for it.

Reminders should respect the participant's day. The reminder ladder sends up to three messages per task (when due, the next day and a final notice before the window closes), observes quiet hours in the participant's time zone and stops once the task is done. Agree the cadence at consent so there are no surprises.

Activity, sleep and heart-rate data add information between visits that a clinic measurement cannot. Capture connects devices through native OAuth: the study team enables a device for the study, the participant signs in to the vendor from their own page and data then sync automatically, with last-sync time, a manual sync option and a disconnect control. Oura is the device we name; confirm any other device with us before you plan around it. For a wider view of device-based designs, see EDC for wearable device studies and the wearable data sharing consent template.

Decide in advance which device outputs are endpoints and which are exploratory, how missing wear days will be treated and who may see participants' device data. Writing these rules into the protocol and the data management plan before enrolment is far cheaper than reconstructing them from an export.