Clinical trial NCT05658315: Investigating the Efficacy of ApplTree on Prospective Memory in Stroke
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke (CVA) or TIA
Memory Impairment
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Prospective Memory Log
timeFrame: Completely weekly throughout baseline and intervention phases (10-13 weeks)
measure: Text Message Log
timeFrame: Completely weekly throughout baseline and intervention phases (10-13 weeks)
Secondary outcomes:
measure: Subjective ratings of worry and effort regarding prospective memory tasks
timeFrame: Completely weekly throughout baseline and intervention phases (10-13 weeks)
measure: Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT)
timeFrame: Completed once after baseline and intervention phases are completed (11-14 weeks to 14-17 weeks)
measure: End of study interview
timeFrame: Completed after baseline and intervention phases are completed (11-14 weeks to 14-17 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: University of Glasgow
name: Jonathan J Evans, BSc, PsyD, PhD
role: STUDY_DIRECTOR
References: