Psychological and Quality of Life Impact of Brain in Hand — BraininHand  

Autism Clinical Trial

Official title: Psychological and Quality of Life Impact of Brain in Hand

Status Completed

Clinical Trial Summary

A prospective cohort mixed study using both qualitative and quantitative elements. The quantitative component will involve tracking outcomes at baseline and at twelve weeks, using Health of the Nation Outcome Scale for People with a Learning Disability (for quality of life) and Hospital Anxiety and Depression Rating Scale (for anxiety and depression). The qualitative study will involve semi structured interviews with end users to understand usage and acceptability of Brain in Hand app with the added impact of the pandemic.

Clinical Trial Description

The Brain in Hand App (BiH) has been awarded a Small Business Research Initiatives competitive grant to develop and test new technologies for the NHS https://braininhand.co.uk/news/brain-in-hand-wins-sbri-healthcare-award/ .

A cohort study is needed to robustly test the BiH technology to evaluate the influence, understand its capabilities, users' experiences, and the effect of clinical impact by looking to align or use the NICE Evidence Framework for Health Digital Technologies, to reference the strengths, weakness, and limitations of BiH specifically around psychological wellbeing and by extension, quality of life. This is the purpose of the study.

There are more than 700,000 autistic people in the United Kingdom. Autism research has focused on causes of autism and largely missed opportunities to discover what helps autistic people. Research highlights that autistic people experience poor mental and physical health, which go unrecognised. Autistic people have very high rates of comorbid physical disabilities as well as mental health conditions that are impacted bilaterally by the social environment. ASD is unique to the person, so person centred support is needed, and a digital solution may offer the best solution in terms of privacy and cost.

NHS England recently reported autistic people have high levels of unmet needs and existing health and social services do not usually cater for this complex group, to deliver person centred support. BiH has developed remote person-centred support with self-management tools with 24/7 helpline that encompasses a wraparound healthcare service. This has recently acquired a further interesting dimension as remote interventions have facilitated enhanced accessibility to healthcare during the pandemic.

The study participants will complete two questionnaires: The self-reporting Hospital Anxiety and Depression Scale and the quality of life, Health of the Nation Scale for people with Learning Disabilities. The questionnaires will gather baseline data and then three months later the same questionnaires will be repeated to understand change. Semi-structured questions will be utilised on a randomly selected sample from the main cohort to gain a user's experience of clinical need and safety. ;

Related Conditions & MeSH terms

• Autism

• NCT number: NCT05468541
• Study type: Observational
• Source: Cornwall Partnership NHS Foundation Trust
• Status: Completed
• Start date: July 30, 2021
• Completion date: March 31, 2022