NCT04551651

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 5, 2019

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

May 24, 2019

Last Update Submit

October 20, 2022

Conditions

Keywords

Assistive Technology for CognitionNeuropsychological Rehabilitation

Outcome Measures

Primary Outcomes (3)

  • Participant recruitment

    The number of service users who take part in the trial

    9 months

  • Attrition to trial sessions

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

    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)

    12 months

Secondary Outcomes (6)

  • Memory performance

    12 months

  • Experiences of using memory apps

    12 months

  • Factor that may influence intervention delivery - technical help

    12 months

  • Factor that may influence intervention delivery - time required for support

    12 months

  • Factor that may influence intervention delivery - learnability of app interventions

    12 months

  • +1 more secondary outcomes

Study Arms (2)

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.

Device: ApplTree

Google Calendar reminder app intervention

ACTIVE COMPARATOR

A widely available calendar app that can be used to set reminders.

Device: Google Calendar

Interventions

ApplTreeDEVICE

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

ApplTree reminder app intervention

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

Google Calendar reminder app intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Acquired Brain Injury (ABI) service, West Dun HSPC Cairnmhor Resource Centre, Joint Hospital Campus

Glasgow, Dunbartonshire, G82 5JA, United Kingdom

RECRUITING

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

Glasgow, Glasgow City, G3 8SJ, United Kingdom

RECRUITING

Quarriers Renfrewshire Acquired Brain Injury service

Paisley, Renfrewshire, PA1 2RH, United Kingdom

RECRUITING

Graham Anderson House, Springburn Road, Springburn

Glasgow, G21 1UU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jonathan Evans

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Jamieson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2019

First Posted

September 16, 2020

Study Start

August 5, 2019

Primary Completion

September 1, 2021

Study Completion

December 31, 2022

Last Updated

October 21, 2022

Record last verified: 2022-10

Locations