Stroke (CVA) or TIANCT05658315
Investigating the Efficacy of ApplTree on Prospective Memory in Stroke
A study testing ApplTree smartphone application in people with Stroke (CVA) or TIA and Memory Impairment, run by NHS Greater Glasgow and Clyde.
Trial summary
After a stroke, people can experience memory problems, including difficulty remembering to do things in the future - termed "prospective memory". This can impact their ability to carry out important activities of daily living (e.g., taking medication), independence, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke (CVA) or TIA, Memory Impairment
- What is being tested?
- ApplTree smartphone application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Aug 2023
- 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
- Community-dwelling individuals who have had a medically-confirmed stroke that occurred at least 3 months prior to recruitment
- Participants must have self- or other-reported prospective memory difficulties
- Participants must share accommodation with their nominated person
- Participants must own and be competent in the use of a smartphone with a reliable internet connection. Nominated persons must also own and be competent in the use of a smartphone and this phone must be separate to that owned by the participants.
- Participants must have capacity to provide informed consent
- Participants must be aged 18 years or over
Who cannot join
- Index stroke <3 months prior to recruitment
- Individuals who do not have capacity to provide informed consent
- Non-fluent English speakers
- Aged <18yrs
- Aphasia (a comprehension and communication disorder that may result from a stroke) that is of a level of severity where it would impact on participants' ability to interact with the ApplTree app and/or complete the study measures
- Diagnosed pre-existing neurological condition
Show all 13Show fewer
- Psychiatric symptoms (e.g., depression) of sufficient severity to prevent engagement with the study
- Pre-existing dementia or acquired brain injury
- Cognitive impairment of sufficient severity that it would prevent the participant from using ApplTree
- Do not currently use a smartphone
- Physical, visual or auditory impairment which, if uncorrected, would prevent the participant from using a smartphone
- Currently participating in other research
- Currently receiving a neuropsychological rehabilitation intervention specifically targeting PM performance
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigating the Efficacy of ApplTree, a Smartphone Reminding Application, on Prospective Memory Performance in Individuals Who Have Experienced a Stroke Using Single Case Experimental Design (SCED)
After a stroke, people can experience memory problems, including difficulty remembering to do things in the future - termed "prospective memory". This can impact their ability to carry out important activities of daily living (e.g., taking medication), independence, and quality of life. Technology-based memory aids, including smartphone applications, can compensate for memory difficulties and are recommended as a 'practice standard' for improving prospective memory impairment following stroke. ApplTree is a smartphone application that was designed for people with memory and attention problems. Users can enter details of future tasks and events and ApplTree then prompts them to remind them to complete these at a pre-specified time. This study will investigate whether ApplTree helps people who have had a stroke and experience prospective memory difficulties to successfully complete prospective memory tasks. It will also explore whether they find ApplTree helpful and easy-to-use.
Read the detailed description
Background: Prospective memory impairment is common following stroke and can significantly impact daily functioning and quality of life. Studies show that technological memory aids, including smartphone applications, are effective in helping compensate for PM difficulties. Wilson (2021) investigated the efficacy of ApplTree, a smartphone reminder application, in three community-dwelling stroke participants with PM difficulties using a multiple baseline across participants, single case experimental design (SCED). Results indicated that ApplTree did not lead to statistically significant improvements in prospective memory performance. However, methodological issues (e.g., self-report and limited response format on Memory Log regarding prospective memory task completion) were highlighted that may have made it difficult to detect any positive effects of ApplTree.
Aims: The proposed study will replicate Wilson (2021) whilst addressing these methodological issues. It is hypothesised that prospective memory performance will improve from baseline to intervention phases, and that ApplTree will be acceptable to participants.
Methods: Participants who have had a stroke and currently experience prospective memory difficulties will be randomly assigned to a 5-, 6- or 7-week baseline phase, where they will continue to do what they normally do to remember tasks in the future. They will then complete training in the use of ApplTree and a 5-week intervention phase, where they will use ApplTree to remind them to complete prospective memory tasks. This will allow us to compare prospective memory performance with and without ApplTree to see if ApplTree makes any difference. A nominated person (e.g., a partner) will record prospective performance during baseline and intervention phases on a Memory Log. Subjective feedback from participants and their nominated person about their experiences of using ApplTree will be gathered after study completion.
Practical Applications: The Stroke Association (2021) have highlighted cognitive and memory difficulties as a top priority for stroke rehabilitation research. This study will contribute to the growing literature on neuropsychological rehabilitation for stroke survivors. Should ApplTree demonstrate efficacy for improving PM performance and be acceptable to participants, it may have utility for stroke rehabilitation.
- Conditions
- Stroke (CVA) or TIA, Memory Impairment
- Being tested
- ApplTree smartphone application
- Medical subject headings
- Stroke, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApplTree smartphone applicationOther
Also called Smartphone reminder tool
ApplTree is a smartphone reminder application which allows the user to enter details of future tasks and events and then prompts the user to remind them to complete these at a pre-specified time. ApplTree was designed with people who experience memory and attention difficulties in mind and has a customisable user interface design to support attention and short-term memory when entering PM tasks. ApplTree was developed by Professor Jonathan Evans and Dr Matthew Jamieson (see Jamieson et al., 2020) and is owned by the University of Glasgow.
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Participants will be randomly assigned to either a 5-, 6-, or 7-week baseline phase. |
| ApplTree intervention | Experimental | Following baseline, participants will complete training in the use of ApplTree and a 5-week intervention phase, where they will utilise ApplTree to set reminders about weekly prospective memory tasks. Receives: Other: ApplTree smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective Memory Log
The participant, their nominated person, and the Principal Investigator will discuss the participant's target prospective memory tasks and their intended completion times at the beginning of each week. These will be recorded on a Memory Log by the nominated person. Only the nominated person will have access to the Memory Log; they will be asked to store this privately so that it does not act as a memory aid or prompt for the participant. The nominated person will record whether these tasks are completed and, if so, whether they are completed on time and if prompting is required.
Measured: Completely weekly throughout baseline and intervention phases (10-13 weeks)
Text Message Log
Participants and nominated persons will be provided with times for the participant to send text messages to the Principal Investigator each week. Days and times will vary to prevent possible practice effects. Successful completion of sending text messages will be recorded by the Principal Investigator.
Measured: Completely weekly throughout baseline and intervention phases (10-13 weeks)
Secondary outcomes (3)
Subjective ratings of worry and effort regarding prospective memory tasks
Participants and nominated persons will be asked to rate time spent worrying about their subjective effort regarding participants' prospective memory tasks for the previous week at the weekly check-in. Responses for each a rated on a 5-point likert scale ranging from 1=Never to 5=Always for Worry ratings and from 1=No effort to 5=A great deal of effort for Effort ratings.
Measured: Completely weekly throughout baseline and intervention phases (10-13 weeks)
Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT)
The UTAUT consists of eight domains (performance expectancy, effort expectancy, social influence, facilitating conditions, hedonic motivation, price value, habit, and behavioural intention). This measure will be adapted to assess participants' perceived usability, usefulness, and intention to use ApplTree after study completion. Responses are rated on a 7-point likert scale from 1=Strongly disagree to 7=Strongly agree.
Participants will be asked to complete the UTAUT after they have completed the baseline and ApplTree intervention phases. This will vary depending on duration of baseline period that participants were randomised to (5, 6, or 7 weeks). Participants will be invited to complete the UTAUT between 1 and 3 weeks post-intervention phase completion (e.g., to allow for things like holidays, illness, etc.).
Measured: Completed once after baseline and intervention phases are completed (11-14 weeks to 14-17 weeks)
End of study interview
Participants and nominated persons will be invited to separately provide subjective feedback regarding their experience of using ApplTree and whether they intend to use it in future, during an end-of-study interview with the Principal Investigator.
Participants and nominated persons will be asked to complete the end of study interview after they have completed the baseline and ApplTree intervention phases. This will vary depending on duration of baseline period that participants were randomised to (5, 6, or 7 weeks). Participants will be invited to complete the UTAUT between 1 and 3 weeks post-intervention phase completion (e.g., to allow for things like holidays, illness, etc.).
Measured: Completed after baseline and intervention phases are completed (11-14 weeks to 14-17 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke (CVA) or TIAStudies 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
- Single group
- Model description
- A multiple baseline across participants, single case experimental design (SCED) will be used. Participants will be randomly assigned to either a 5-, 6-, or 7-week baseline phase. They will then complete training in the use of ApplTree and a 5-week intervention phase.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan J Evans, BSc, PsyD, PhD, Study director, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658315
- Sponsor's protocol ID
- GN22ST389
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised participant data may be made available to other researchers with participants' consent. Study to undergo Research Ethics Review.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of ApplTree, a Smartphone Reminding Application, on Prospective Memory Performance in Individuals Who Have Experienced a Stroke Using Single Case Experimental Design (SCED)
- ClinicalTrials.gov ID
- NCT05658315
- Acronym / sponsor ID
- GN22ST389
- Conditions
- Stroke (CVA) or TIA, Memory Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 20 Dec 2022 (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.
After a stroke, people can experience memory problems, including difficulty remembering to do things in the future - termed "prospective memory". This can impact their ability to carry out important activities of daily living (e.g., taking medication), independence, and quality of life. Technology-based memory aids, including smartphone applications, can compensate for memory difficulties and are recommended as a 'practice standard' for improving prospective memory impairment following stroke. ApplTree is a smartphone application that was designed for people with memory and attention problems. Users can enter details of future tasks and events and ApplTree then prompts them to remind them to complete these at a pre-specified time. This study will investigate whether ApplTree helps people who have had a stroke and experience prospective memory difficulties to successfully complete prospective memory tasks. It will also explore whether they find ApplTree helpful and easy-to-use.
Detailed description
Background: Prospective memory impairment is common following stroke and can significantly impact daily functioning and quality of life. Studies show that technological memory aids, including smartphone applications, are effective in helping compensate for PM difficulties. Wilson (2021) investigated the efficacy of ApplTree, a smartphone reminder application, in three community-dwelling stroke participants with PM difficulties using a multiple baseline across participants, single case experimental design (SCED). Results indicated that ApplTree did not lead to statistically significant improvements in prospective memory performance. However, methodological issues (e.g., self-report and limited response format on Memory Log regarding prospective memory task completion) were highlighted that may have made it difficult to detect any positive effects of ApplTree.
Aims: The proposed study will replicate Wilson (2021) whilst addressing these methodological issues. It is hypothesised that prospective memory performance will improve from baseline to intervention phases, and that ApplTree will be acceptable to participants.
Methods: Participants who have had a stroke and currently experience prospective memory difficulties will be randomly assigned to a 5-, 6- or 7-week baseline phase, where they will continue to do what they normally do to remember tasks in the future. They will then complete training in the use of ApplTree and a 5-week intervention phase, where they will use ApplTree to remind them to complete prospective memory tasks. This will allow us to compare prospective memory performance with and without ApplTree to see if ApplTree makes any difference. A nominated person (e.g., a partner) will record prospective performance during baseline and intervention phases on a Memory Log. Subjective feedback from participants and their nominated person about their experiences of using ApplTree will be gathered after study completion.
Practical Applications: The Stroke Association (2021) have highlighted cognitive and memory difficulties as a top priority for stroke rehabilitation research. This study will contribute to the growing literature on neuropsychological rehabilitation for stroke survivors. Should ApplTree demonstrate efficacy for improving PM performance and be acceptable to participants, it may have utility for stroke rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A multiple baseline across participants, single case experimental design (SCED) will be used. Participants will be randomly assigned to either a 5-, 6-, or 7-week baseline phase. They will then complete training in the use of ApplTree and a 5-week intervention phase.
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Participants will be randomly assigned to either a 5-, 6-, or 7-week baseline phase. |
| ApplTree intervention | Experimental | Other: ApplTree smartphone applicationFollowing baseline, participants will complete training in the use of ApplTree and a 5-week intervention phase, where they will utilise ApplTree to set reminders about weekly prospective memory tasks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Community-dwelling individuals who have had a medically-confirmed stroke that occurred at least 3 months prior to recruitment
- Participants must have self- or other-reported prospective memory difficulties
- Participants must share accommodation with their nominated person
- Participants must own and be competent in the use of a smartphone with a reliable internet connection. Nominated persons must also own and be competent in the use of a smartphone and this phone must be separate to that owned by the participants.
- Participants must have capacity to provide informed consent
Key exclusion criteria (13 listed)
- Index stroke <3 months prior to recruitment
- Individuals who do not have capacity to provide informed consent
- Non-fluent English speakers
- Aged <18yrs
- Aphasia (a comprehension and communication disorder that may result from a stroke) that is of a level of severity where it would impact on participants' ability to interact with the ApplTree app and/or complete the study measures
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 |
|---|---|---|
| ApplTree smartphone applicationAlso: Smartphone reminder toolApplTree is a smartphone reminder application which allows the user to enter details of future tasks and events and then prompts the user to remind them to complete these at a pre-specified time. ApplTree was designed with people who experience memory and attention difficulties in mind and has a customisable user interface design to support attention and short-term memory when entering PM tasks. ApplTree was developed by Professor Jonathan Evans and Dr Matthew Jamieson (see Jamieson et al., 2020) and is owned by the University of Glasgow. | Other | ApplTree intervention |
Primary outcome
Prospective Memory Log
Time frame: Completely weekly throughout baseline and intervention phases (10-13 weeks)
The participant, their nominated person, and the Principal Investigator will discuss the participant's target prospective memory tasks and their intended completion times at the beginning of each week. These will be recorded on a Memory Log by the nominated person. Only the nominated person will have access to the Memory Log; they will be asked to store this privately so that it does not act as a memory aid or prompt for the participant. The nominated person will record whether these tasks are completed and, if so, whether they are completed on time and if prompting is required.
Text Message Log
Time frame: Completely weekly throughout baseline and intervention phases (10-13 weeks)
Participants and nominated persons will be provided with times for the participant to send text messages to the Principal Investigator each week. Days and times will vary to prevent possible practice effects. Successful completion of sending text messages will be recorded by the Principal Investigator.
3 secondary outcomes
Subjective ratings of worry and effort regarding prospective memory tasks
Time frame: Completely weekly throughout baseline and intervention phases (10-13 weeks)
Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT)
Time frame: Completed once after baseline and intervention phases are completed (11-14 weeks to 14-17 weeks)
End of study interview
Time frame: Completed after baseline and intervention phases are completed (11-14 weeks to 14-17 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: Undecided. Anonymised participant data may be made available to other researchers with participants' consent. Study to undergo Research Ethics Review.
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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 J Evans, BSc, PsyD, PhD study director
University of Glasgow
Questions about this trial
What is this clinical trial studying?
A study testing ApplTree smartphone application in people with Stroke (CVA) or TIA and Memory Impairment, run by NHS Greater Glasgow and Clyde.
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 6 inclusion and 13 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 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Corinna A Stewart, BA, PhD (0141 211 3920, corinna.stewart@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective Memory Log (time frame: Completely weekly throughout baseline and intervention phases (10-13 weeks)). The study lists 2 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 20 Dec 2022.