Digital Interventions in Neuro-Rehabilitation (DINR)

• Research type

  Research Study

• Full title

  Digital Interventions in Neuro-Rehabilitation: Two digital neuro interventions (DNIs) for word retrieval. The development and testing of two web-based therapy applications for people with naming difficulties caused by Stroke (iTALKbetter) or Mild-Moderate Dementia (Gotcha!).

• IRAS ID

  237795

• Contact name

  Alexander P Leff

• Contact email

  a.leff@ucl.ac.uk

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  n/a, n/a

• Duration of Study in the UK

  3 years, 1 months, 23 days

• Research summary

  The main aim is to test the clinical efficacy of two novel, web-based, rehabilitation applications funded by NIHR that were designed in Phase 1 of this study (REC 17/LO/1846).
  iTALKbetter will provide an app-based therapy for people with naming difficulties caused by stroke (naming app for a wide variety of common words and phrases), while Gotcha! will be for patients with dementia (who have difficulty
  naming people they know well). These two digital neuro interventions (DNIs) will provide the opportunity for the
  necessary increased rehabilitation that help people recover lost function. This will alleviate NHS therapist (SALT) time
  and put patients in control of when and where the carry out practice-based language therapy.
  While both apps will be aimed at different patient populations, the underlying software and development pipelines are
  almost identical, hence our combining them here for the purposes of ethical review.
  Each app will go through three separate phases, each of which will require specific patient information sheets and
  formal consent: Phase 1 (HRA approved) is development of the app (with patients as co-creators, currently underway); the second phase is a standard,
  small-scale phase II clinical trial with randomized allocation of subjects; phase 3 is ‘roll-out’ where the app is made
  publicly available. Ethical approval for phase 3 will only be sought after sufficient evidence for the efficacy of the apps is gained from phase 2. During phase 3 we will continue to ask scientific questions about the real-world functioning of the app in this phase.

  This application seeks approval for phase 2 only.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  18/EE/0228

• Date of REC Opinion

  5 Sep 2018

• REC opinion

  Further Information Favourable Opinion