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Acquired Brain InjuryNCT04551651

AppReminders - A Pilot Feasibility Trial of a Memory Aid App for People With Acquired Brain Injury

A study testing ApplTree and Google Calendar in people with Acquired Brain Injury, run by NHS Greater Glasgow and Clyde at 4 sites in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

People with brain injury commonly experience difficulties with memory, concentration, attention and judgement, meaning that important everyday actions and tasks are not carried out or not completed, limiting the ability to live independently. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acquired Brain Injury
What is being tested?
ApplTree and Google Calendar
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesUnited Kingdom
Study dates
5 Aug 2019to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 or over
  • Acquired brain injury
  • Self or other reported memory difficulties resulting from an acquired brain injury

Who cannot join

  • Inability to provide informed consent for research participation
  • Does not own a smartphone compatible with ApplTree and Google Calendar
  • Inadequate writing or reading (English) which would impair comprehension and performance of experimental tasks, and / or answering of questionnaires.
  • Inability to verbally communicate adequately in an experimental setting
  • Severe physical or sensory disability which would prevent any attempt at using a typical smartphone device (e.g. paralysis of both upper limbs).

Trial locations and contacts

4 sites in 1 country.

Matthew Jamieson, PhD contact

07717780272

matthew.jamieson@glasgow.ac.uk

United Kingdom4 sites, 4 recruiting
  • Acquired Brain Injury (ABI) service, West Dun HSPC Cairnmhor Resource Centre, Joint Hospital Campus

    Glasgow, Dunbartonshire, G82 5JA

    Jean McFarlane, jean.mcfarlane2@ggc.scot.nhs.uk

    Recruiting
  • Community treatment Centre for Brain Injury, West Glasgow ACH Dalnair Street

    Glasgow, Glasgow City, G3 8SJ

    Nicola Goudie, Nicola.Goudie@ggc.scot.nhs.uk

    Recruiting
  • Graham Anderson House, Springburn Road, Springburn

    Glasgow, G21 1UU

    Brian O'Neill, Brian.ONeill@thedtgroup.org

    Recruiting
  • Quarriers Renfrewshire Acquired Brain Injury service

    Paisley, Renfrewshire, PA1 2RH

    Margaret McIntyre, headinjuryservice@quarriers.org.uk

    Margaret McIntyre

    Recruiting

Other trials in United Kingdom

About this study

Official title: AppReminders Trial - A Pilot Feasibility Trial of a Memory Aid App for People With Acquired Brain Injury

People with brain injury commonly experience difficulties with memory, concentration, attention and judgement, meaning that important everyday actions and tasks are not carried out or not completed, limiting the ability to live independently. Technology-based solutions, including smartphone applications, can help by providing prompts about intended actions at the correct time. However, memory and attention impairments mean people forget to set reminders or fail to set them accurately (e.g. setting the wrong time/date for events). Using co-design methods with prospective users, the investigators developed ApplTree, a smartphone reminding application with design features that can be personalised to individuals. ApplTree prompts reminder setting, supports reminder entry to improve accuracy, and delivers users with prompts at the appropriate times. A pilot randomised controlled trial will be conducted to provide crucial information to inform a future larger scale efficacy trial of ApplTree as an intervention to support memory in people with acquired brain injury.

Read the detailed description

Rationale Brain injury is a leading cause of disability in Scotland. The British Society of Rehabilitation Medicine reports the prevalence of head injury in the UK to be 300 per 100,000 and the prevalence of disabled survivors of brain injury is 100-150 per 100,000. A particularly high prevalence of disability following hospitalisation for brain injury has been reported in Scotland (4.5 times higher than the Department of Health prevalence estimate).

People with brain injury commonly experience difficulties with memory, concentration, attention and judgement, meaning that important everyday actions and tasks are not carried out or not completed, limiting the ability to live independently. Technology-based solutions, including smartphone applications, can help by providing prompts about intended actions at the correct time. However, memory and attention impairments mean people forget to set reminders or fail to set them accurately (e.g. setting the wrong time/date for events). Using co-design methods with prospective users, the investigators developed ApplTree, a smartphone reminding application with design features that can be personalised to individuals. ApplTree prompts reminder setting, supports reminder entry to improve accuracy, and delivers users with prompts at the appropriate times. The investigators wish to find out if such an intervention can improve the everyday memory performance of individuals with memory difficulties following acquired brain injury compared to an off-the-shelf reminding app (Google Calendar). During this project a pilot randomised controlled trial will be conducted to provide crucial information to inform a future larger scale efficacy trial of ApplTree as an intervention to support memory in people with acquired brain injury.

ApplTree app The investigators designed ApplTree with features that our research suggests can help support independent use and increase the efficacy of prompting technology interventions, and which can be personalised according to need and preference.

User Interface (UI) Type: ApplTree has the option of a traditional 'broad-shallow' UI or a 'narrow-deep' UK. The 'narrow-deep' UI has several screens but little information on each screen. Previous research has indicated that this is preferable for people with cognitive impairments when searching for content online compared to the alternative, and more common, 'broad-shallow' UI that contains lots of information on each screen but a small number of screens.

Unsolicited Prompts (UPs): ApplTree provides periodic prompts to encourage the user to set reminders. This is helpful if people have self-monitoring, initiation or mood problems that are common after neurological injury. The investigators investigated UP's previously using a single case experimental design (n=3). Participants set more reminders when receiving UPs illustrating their potential to increase reminder setting. More investigation is needed to understand how they influence acceptability.

Carer Support in App: Reminding software that allows input from carers can be effective as a memory aid. ApplTree allows carer input so that carers can, when appropriate, set reminders and send prompts to the patient.

Scientific justification Technologies that send timely prompts to people about everyday activities are an effective, low cost solution to support people with cognitive impairments after brain injury. Our systematic review and meta-analysis found that prompting technology improves memory performance for people with memory difficulties vs. practice as usual or a paper diary/calendar (d = 1.27, large effect size, n=147). Reminding technology can also reduce the burden on caregivers. This potential positive impact will only be seen in practice if people have access to this technology (e.g. as part of their clinical rehabilitation). The positive impact of reminding technology use will be greater if people are able to use the technology independently when it is provided, and if the technology meets the individual needs of the users. Our systematic review found few papers that investigated smartphone apps (the state-of-the-art technology for delivering prompts) delivered through a clinical service. Furthermore, only three studies asked participants to set reminders independently, which is crucial to increasing functional independence. Our research with smartphone users with ABI has highlighted that memory and attention difficulties prevent people from making effective use of reminding apps. Due to cognitive impairments impacting usability, those who could benefit most from reminding technology are the people for whom it is least accessible. This may explain why uptake of reminding technology is currently low. There is, however, insufficient evidence regarding the best user interface design for apps to ensure that people with cognitive impairments are able to use them independently. It is also unknown whether it is feasible and effective to introduce an app with these features to patients through clinical services. Answering these questions is vital for this intervention to improve independent functioning and alleviate caregiver burden.

This project will build on extensive previous work developing ApplTree - smartphone reminding software with personalisable features, specifically designed for people with brain injury to improve everyday functioning. Interventions that can be tailored to individuals' needs are consistent with the drive towards personalised/ stratified medicine and treatment delivery. The investigators will undertake a user study and a pilot randomised controlled trial that will underpin a large-scale RCT to examine efficacy.

Being tested
ApplTree, Google Calendar
Keywords
Assistive Technology for Cognition, Neuropsychological Rehabilitation
Medical subject headings
Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApplTreeDevice

    App downloaded on the participants phone, a short video tutorial session to explain use, and technical support throughout trial period.

  • Google CalendarDevice

    App downloaded on the participants phone, a short video tutorial session to explain use, and technical support throughout trial period.

Study groups in NCT04551651
Study groupRoleWhat they receive
ApplTree reminder app interventionActive comparatorA reminding app developed with features that, based on previous research, will increase use and ease of use for individuals with ABI when setting smartphone reminders.
Receives: Device: ApplTree
Google Calendar reminder app interventionActive comparatorA widely available calendar app that can be used to set reminders.
Receives: Device: Google Calendar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant recruitment

    The number of service users who take part in the trial

    Measured: 9 months

  2. Attrition to trial sessions

    Proportion of those randomised that attended the first, second and third follow-up sessions

    Measured: 12 months

  3. Adherence to intervention

    Proportion of people using Google Calendar or ApplTree at least once during each of the three follow-up weeks during the intervention phase (weeks 10, 11 and 12)

    Measured: 12 months

Secondary outcomes (6)
  1. Memory performance

    Mean and standard variation of the difference between individual's memory performance in baseline phase (no intervention) and intervention phases (either ApplTree or Google Calendar)

    Measured: 12 months

  2. Experiences of using memory apps

    Feedback from participant's about their experiences in the trial and using the apps

    Measured: 12 months

  3. Factor that may influence intervention delivery - technical help

    1. number of times each participant asked for technical help, b) who was asked to solve each issue, c) who was able to solve this technical issue d) a short description of what the problem was

    Measured: 12 months

  4. Factor that may influence intervention delivery - time required for support

    The amount of the clinician's and researcher's time spent helping with technical issues outside of the main study sessions

    Measured: 12 months

  5. Factor that may influence intervention delivery - learnability of app interventions

    the number of times each participant had to do the assessment questions before they received a high enough score to end the intervention session. Pass mark is 60% of the information correctly entered.

    Measured: 12 months

  6. Factor that may influence intervention delivery - neuropsychological profile

    • All participants will be given four cognitive scores based on the measures provided; a memory, executive function, attention and combined 'overall cognition' score (the mean of memory, attention and executive function measures). Scaled scores or percentile rank scores will be used. Higher scores on these tests mean better cognitive ability.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start5 Aug 2019
  3. Primary completion1 Sep 2021
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551651
Sponsor's protocol ID
GN19NE236
Status last verified
Oct 2022
First submitted
24 May 2019
Last updated
21 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing ApplTree and Google Calendar in people with Acquired Brain Injury, run by NHS Greater Glasgow and Clyde at 4 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Matthew Jamieson, PhD (07717780272, matthew.jamieson@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant recruitment (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.

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