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.
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.
United Kingdom4 sites, 4 recruiting
- 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
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.
- Conditions
- Acquired Brain Injury
- 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 group | Role | What they receive |
|---|---|---|
| ApplTree reminder app intervention | Active comparator | A 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 intervention | Active comparator | A 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.
Participant recruitment
The number of service users who take part in the trial
Measured: 9 months
Attrition to trial sessions
Proportion of those randomised that attended the first, second and third follow-up sessions
Measured: 12 months
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)
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
Experiences of using memory apps
Feedback from participant's about their experiences in the trial and using the apps
Measured: 12 months
Factor that may influence intervention delivery - technical help
- 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
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
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
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.
- First posted16 Sep 2020
- Study start5 Aug 2019
- Primary completion1 Sep 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Chief Scientist Office of the Scottish Government
- Responsible party
- Sponsor
- Investigators
- Jonathan Evans, Principal investigator, University of Glasgow
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AppReminders Trial - A Pilot Feasibility Trial of a Memory Aid App for People With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT04551651
- Acronym / sponsor ID
- GN19NE236
- Conditions
- Acquired Brain Injury
- Keywords
- Assistive Technology for Cognition, Neuropsychological Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow, Chief Scientist Office of the Scottish Government
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ApplTree reminder app intervention | Active comparator | Device: ApplTreeA 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. |
| Google Calendar reminder app intervention | Active comparator | Device: Google CalendarA widely available calendar app that can be used to set reminders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 or over
- Acquired brain injury
- Self or other reported memory difficulties resulting from an acquired brain injury
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApplTreeApp downloaded on the participants phone, a short video tutorial session to explain use, and technical support throughout trial period. | Device | ApplTree reminder app intervention |
| Google CalendarApp downloaded on the participants phone, a short video tutorial session to explain use, and technical support throughout trial period. | Device | Google Calendar reminder app intervention |
Primary outcome
Participant recruitment
Time frame: 9 months
The number of service users who take part in the trial
Attrition to trial sessions
Time frame: 12 months
Proportion of those randomised that attended the first, second and third follow-up sessions
Adherence to intervention
Time frame: 12 months
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)
6 secondary outcomes
Memory performance
Time frame: 12 months
Experiences of using memory apps
Time frame: 12 months
Factor that may influence intervention delivery - technical help
Time frame: 12 months
Factor that may influence intervention delivery - time required for support
Time frame: 12 months
Factor that may influence intervention delivery - learnability of app interventions
Time frame: 12 months
Factor that may influence intervention delivery - neuropsychological profile
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Evans principal investigator
University of Glasgow
4 sites in 1 country: see every site and its status.
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.