Designing a Smart Clinical Trial for Smarter Care

Scientific rigour is essential to any clinical trial but so is flexibility. The TeleRehaB DSS trial combines both. Designed as a randomised controlled study, it evaluates not just whether the intervention works, but how different levels of digital support affect engagement, adherence and outcomes across diverse patient populations.

Inclusion with precision

Eligibility for the study is defined by clear clinical and functional criteria. Participants must:

  • Be aged 40–80
  • Live independently and be able to walk 500 metres (with or without assistance)
  • Have a diagnosis of one of the study conditions: stroke, MCI, vestibular disorder or long COVID-19
  • Have no additional neurological conditions (e.g. Parkinson’s, MS, neuropathy)
  • Be able to provide informed consent and use digital tools
  • Not currently be receiving falls/balance/cognitive rehabilitation or have participated in a clinical drug trial in the previous 6 months

These criteria ensure an appropriate and consistent study population across sites. All supporting materials, including participant information sheets and consent forms, have been reviewed and adapted to reflect each site’s cultural and linguistic context.

Randomised arms, tailored Support

Participants will be randomly assigned to one of three groups:

  • High-tech intervention: Full TeleRehaB DSS platform with virtual coaching, mobile app, dashboard and wearable sensors
  • Low-tech intervention: Simplified intervention without wearables and with limited digital tools
  • Control group: A standardised home exercise programme (e.g. OTAGO or Meniere’s Society materials)

All three arms include weekly phone check-ins and standardised review procedures. A central randomisation system ensures transparency and scientific rigour.

Measuring what matters

The trial uses a combination of clinical and patient-reported outcomes. These include:

  • EQ-5D-5L: quality of life
  • FGA (Functional Gait Assessment): gait and balance
  • MoCA: cognitive function
  • DHI, HADS, ABC, RAPA, SCQ, WEMWBS, Fatigue Severity Scale: patient experience
  • eHealth Literacy Assessment, including STAM-14 and MDPQ, to measure digital literacy

By collecting both quantitative and experiential data, the study will provide a detailed understanding of clinical impact, patient usability and engagement.

Adaptive and patient-centred

Progression through the intervention is not automatic. Participants report their readiness to move forward, and clinicians can pause or adjust the programme based on symptoms or functional status. This is especially critical for participants recovering from long COVID-19, where fatigue and cognitive symptoms may fluctuate. This responsive approach, tested during the pilot phase, ensures that participants feel safe and supported and that clinicians can deliver care adapted to individual needs.

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