Investigating the Efficacy of ApplTree on Prospective Memory in Stroke

NCT05658315 | Unknown

• 1 other identifier: GN22ST389
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke (CVA) or TIA; Memory Impairment

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Completely weekly throughout baseline and intervention phases (10-13 weeks)

Secondary Outcomes (3)

• Subjective ratings of worry and effort regarding prospective memory tasks

  Completely weekly throughout baseline and intervention phases (10-13 weeks)

• Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT)

  Completed once after baseline and intervention phases are completed (11-14 weeks to 14-17 weeks)

• End of study interview

  Completed after baseline and intervention phases are completed (11-14 weeks to 14-17 weeks)

Study Arms (2)

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.

Other: ApplTree smartphone application

Interventions

ApplTree smartphone application OTHER

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.

Also known as: Smartphone reminder tool

ApplTree intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

MeSH Terms

Conditions

Stroke; Memory Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan J Evans, BSc, PsyD, PhD

  University of Glasgow

  STUDY DIRECTOR

Central Study Contacts

Corinna A Stewart, BA, PhD

CONTACT

0141 211 3920; corinna.stewart@ggc.scot.nhs.uk

Jonathan J Evans, BSc, PsyD, PhD

CONTACT

0141 211 0694; Jonathan.Evans@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 20, 2022
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: December 20, 2022

Record last verified: 2022-12