Psychological and Quality of Life Impact of Brain in Hand

Autism Clinical Trial

— BraininHand  

Official title:

Psychological and Quality of Life Impact of Brain in Hand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05468541
• Other study ID #: Version 4 25.10.21
• Status: Completed
• Start date: July 30, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2022
• Source: Cornwall Partnership NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Age ranges from 19 to 80.

3. Participant has been screened by the Columbia Suicide Rating Scale as not having risk concerns of suicide.

4. Access to smart devices with compatibility to running BiH. The Participant will require a Smart Phone and either a Laptop / Tablet / Note Book.

5. Has capacity to give informed consent and can give informed consent.

6. They can understand the BiH information.

Exclusion Criteria:

1. Outside of stated age range within the inclusion criteria.

2. Any acute or chronic condition, particularly neurodevelopmental conditions such as significant intellectual disability, Level 2/3 DSM V ASD.

3. Diagnosed con-current psychological comorbidity (psychosis, severe depression etc.) that would limit the ability of the participant to take part in the study.

4. 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.

6. Not willing to engage with smart device/internet. 7. Insufficient English language to understand and complete questionnaires.

Related Conditions & MeSH terms

• Autism

Locations

Country	Name	City	State
United Kingdom	Cornwall Partnership NHS Foundation Trust	Bodmin	Cornwall

Sponsors (2)

Lead Sponsor	Collaborator
Cornwall Partnership NHS Foundation Trust	braininhand.co.uk

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	What is the impact of BiH on quality of life over a three-month period?	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	3 months
Primary	What is the impact of BiH on the participant's mental health?	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 months
Primary	Level of acceptability (drop-out rates)	Drop out rates will be recorded	3 months
Primary	Discover the participant's experience of using BiH App to measure outcomes of reliance on their care support	Short semi structured interviews with ten end users to understand usage and acceptability	3 months
Primary	Understand how BiH impacts on coping skills	Short semi structured interviews with ten end users to understand usage and acceptability	3 months
Primary	To gain understanding of how BIH has impacted on the autistic person's ability to manage challenging social situations	Short semi structured interviews with ten end users to understand usage and acceptability	3 months
Primary	Does BiH App help autistic people feel safe?	Short semi structured interviews with ten end users to understand usage and acceptability	3 months
Primary	Does the BiH help autistic people feel more independent?	Short semi structured interviews with ten end users to understand usage and acceptability	3 months
Primary	Can access 24/7 telephone support help autistic people feel self-empowered to manage their anxiety?	Short semi structured interviews with ten end users to understand usage and acceptability	3 months
Primary	To gain an understanding of how BiH Traffic Light system helps a person manage their anxiety, independence and support their coping skills	Short semi structured interviews with ten end users to understand usage and acceptability	3 months
Primary	Does the participant believe remote support has improved their access to healthcare during the pandemic?	Short semi structured interviews with ten end users to understand usage and acceptability	3 months