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OpenTrials
Completed

NCT Number: NCT05468541

Psychological and Quality of Life Impact of Brain in Hand

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.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cornwall Partnership NHS Foundation Trust

Bodmin, Cornwall, PL31 2QN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All who have been diagnosed with Autism Spectrum Disorder (ASD) as per DSM-5 criteria level (1) or post screening by health professional such as a GP and on the confirmatory diagnostic pathway.
  • Age ranges from 19 to 80.
  • Participant has been screened by the Columbia Suicide Rating Scale as not having risk concerns of suicide.
  • Access to smart devices with compatibility to running BiH. The Participant will require a Smart Phone and either a Laptop / Tablet / Note Book.
  • Has capacity to give informed consent and can give informed consent.
  • They can understand the BiH information.

Exclusion criteria

  • Outside of stated age range within the inclusion criteria.
  • Any acute or chronic condition, particularly neurodevelopmental conditions such as significant intellectual disability, Level 2/3 DSM V ASD.
  • Diagnosed con-current psychological comorbidity (psychosis, severe depression etc.) that would limit the ability of the participant to take part in the study.
  • Anyone who declines to give consent or are unable to give informed consent. 5. Anyone who has been screened positive with the (C-SSRS) suicide risk scale.
  • Not willing to engage with smart device/internet. 7. Insufficient English language to understand and complete questionnaires.

Treatment and study plan

Primary outcomes

  1. What is the impact of BiH on quality of life over a three-month period?

    Time frame: 3 months

    The Health of the Nation Outcome Scales for People with Learning Disabilities is measured on a five-point scale (0-4) with 0 being no problem and 4 being very severe. It is completed at Baseline and 3 months and the scores will be compared

  2. What is the impact of BiH on the participant's mental health?

    Time frame: 3 months

    Hospital Anxiety and Depression Scale is measured on a four-point scale (0-3) with 0 being no problem and 4 being very severe. It is completed at Baseline and 3 months and the scores will be compared

  3. Level of acceptability (drop-out rates)

    Time frame: 3 months

    Drop out rates will be recorded

  4. Discover the participant's experience of using BiH App to measure outcomes of reliance on their care support

    Time frame: 3 months

    Short semi structured interviews with ten end users to understand usage and acceptability

  5. Understand how BiH impacts on coping skills

    Time frame: 3 months

    Short semi structured interviews with ten end users to understand usage and acceptability

  6. To gain understanding of how BIH has impacted on the autistic person's ability to manage challenging social situations

    Time frame: 3 months

    Short semi structured interviews with ten end users to understand usage and acceptability

  7. Does BiH App help autistic people feel safe?

    Time frame: 3 months

    Short semi structured interviews with ten end users to understand usage and acceptability

  8. Does the BiH help autistic people feel more independent?

    Time frame: 3 months

    Short semi structured interviews with ten end users to understand usage and acceptability

  9. Can access 24/7 telephone support help autistic people feel self-empowered to manage their anxiety?

    Time frame: 3 months

    Short semi structured interviews with ten end users to understand usage and acceptability

  10. To gain an understanding of how BiH Traffic Light system helps a person manage their anxiety, independence and support their coping skills

    Time frame: 3 months

    Short semi structured interviews with ten end users to understand usage and acceptability

  11. Does the participant believe remote support has improved their access to healthcare during the pandemic?

    Time frame: 3 months

    Short semi structured interviews with ten end users to understand usage and acceptability

Sponsors and collaborators

Lead sponsor

Cornwall Partnership NHS Foundation Trust

Network

Collaborators

  • braininhand.co.uk

Registry information

Acronym: BraininHand

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 21, 2022
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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