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Digital Interventions in Neuro-Rehabilitation: Gotcha!

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ClinicalTrials.gov Identifier: NCT04570215
Recruitment Status : Recruiting
First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:

Aims and background Everyone forgets the names of people they should know at times. Having dementia makes this problem worse. People with dementia have told expressed they forget the names of people they care about and this can be upsetting and embarrassing.

However, evidence shows that if people get enough practice, they can re-learn these names. The investigators, along with people with dementia and their carers, have created a fun therapy for people to get lots of practice so they can remember the names of people that are important to them.

The main aim of the study is:

To prove that Gotcha! therapy can help people with dementia to improve their ability to remember names.

Another aim is:

To find out if using the therapy is related to any changes in the brains of people with dementia.

Design and methods Participants are provided with a computer tablet to practise at home. Participants are required to think of 6-10 familiar people (family and friends) whose names they forget and want to remember better.

Participants also need to practise every day for about 30 minutes over a 6 week period so they get a large amount of therapy.

Participants will have 7 testing appointments over 12 months. At three of these appointments participants will need to have a brain scan. These scans are carried out by trained University College London professionals and will take no longer than 30 minutes each.

For the appointments where participants do not need to have a brain scan home testing can be arranged.

The investigators organise and pay for all journeys to and from University College London.

Participants

Participants can get involved in our research if they:

  • Have ever experiences seeing a familiar person but can't remember their name
  • Have a diagnosis of dementia (Alzheimer's disease or mixed dementia).
  • Want to be part of an important and exciting research journey. Unfortunately a diagnosis of other any other types of dementia not mentioned above is not suitable for this study

Patient and Public involvement The investigators have engaged with people from the Alzheimer's Society and local dementia carers groups, run many focus groups and interviewed people with dementia and their carers to co-design the therapy.

At the end of our research participants are invited to University College London to learn about the results of the study.


Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Anomia Other: Gotcha! Therapy application Other: Gotcha Therapy application: Maintenance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Digital Interventions in Neuro-Rehabilitation: A Small Scale Randomised Clinical Trial to Test a Web-based Therapy Application for People With Naming Difficulties With Mild- Moderate Dementia (Gotcha!).
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Gotcha! Therapy Application

Participants will receive the Gotcha therapy daily for six weeks.Participants are required to use the app everyday for a maximum of 45 minutes. After this time they enter a twelve week block with no therapy or maintenance of therapy (see Gotcha maintenance arm).

This aim of this arm is to invesitgate the efficacy of the Gotcha therapy for proper-noun anomia in mild-moderate patients with dementia (Alzheimer's disease, vascular dementia and mixed)

Other: Gotcha! Therapy application

Gotcha! will provide an app-based therapy for people with dementia who have difficulty naming people they know well.

The therapy element works via mass practice and feedback to the users on a trial-by-trial basis. The DNI is very simple in a way; it just presents a long series of pictures for users to name. This DNI will use speech recognition (SR) software in order to make a binary decision as to whether the user said the correct word or not. This affects what the next trial (object to name) is and what auditory cue (if any) is provided the next time the user has to name the same item.

Other Name: Gotcha!

Active Comparator: Gotcha! Therapy Application: Maintenance

Participants will receive the Gotcha therapy for six weeks as described in the Gotcha arm. After this time they enter a twelve week block of maintenance of therapy gains made in the initial six week therapy block.

The maintenance block consists of a weekly test of the Gotcha outcome measure to monitor the therapy gains made during the therapy block. If any previously correctly named person is incorrectly named during these weekly tests then the participant must complete a 'top-up' therapy session. They will then be tested again the following week.

The aim of this arm is to compare Gotcha maintenance with Gotcha, to see if extra testing and therapy is required to maintain gains made during an initial intense therapy block.

Other: Gotcha! Therapy application

Gotcha! will provide an app-based therapy for people with dementia who have difficulty naming people they know well.

The therapy element works via mass practice and feedback to the users on a trial-by-trial basis. The DNI is very simple in a way; it just presents a long series of pictures for users to name. This DNI will use speech recognition (SR) software in order to make a binary decision as to whether the user said the correct word or not. This affects what the next trial (object to name) is and what auditory cue (if any) is provided the next time the user has to name the same item.

Other Name: Gotcha!

Other: Gotcha Therapy application: Maintenance
Gotcha! Maintenance therapy is identical to Gotcha! but takes place over a longer period of time in an attenuated form.
Other Name: Gotcha Maintenance




Primary Outcome Measures :
  1. Change in performance on the Gotcha Outcome Measure (GOM) over time [ Time Frame: Baseline (week 1), pre-intervention (week 12) ,post-intervention (week 18) ]
    The Gotcha Outcome measure is a personalised test specific to each participant that enters the study. Each participant is required to select photographs of people whom they struggle to name. These photographs are used to create a personalised confrontation naming test i.e participants are shown a picture of a person they want to name better, they then get 8seconds to give a response. If a participant correctly names the person they were shown they are given a binary score of 1 (0 if they name incorrectly or cannot name). These scores can then be totalled and a percentage accuracy can be devised. The change in accuracy from baselines to pre therapy (6weeks) and pre therapy to post therapy time-points (6 weeks) is the primary outcome measure in the study.


Secondary Outcome Measures :
  1. Participant reported outcome measures [ Time Frame: pre intervention (week 12), post intervention (week 18) ]
    Qualitative semi-structured interviews with both participant and their carer/spouse/partner or family member present.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Person with mild/moderate dementia
  • Self-reported proper naming difficulty which we will then assess at Time Point 1 English as their dominant language
  • Able to tolerate MRI brain scan
  • Able to give informed consent
  • Able to use the DNI (app)

Exclusion Criteria:

  • No diagnosis of developmental language disorders
  • No diagnosis of severe dementia or primary progressive aphasia
  • No major co-existing neurological or psychiatric diagnosis
  • No contraindications to brain scanner (e.g. the presence of ferromagnetic implants or other metallic or electronic objects in the body, weight over 24 stone, claustrophobia or pregnancy).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570215


Contacts
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Contact: Alexander P Leff, Professor 02076791177 a.leff@ucl.ac.uk
Contact: Catherine Doogan, PhD 02076791134 c.doogan@ucl.ac.uk

Locations
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United Kingdom
University College London Recruiting
London, United Kingdom, WC1E6BT
Contact: Alexander P Leff, Prof         
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Alexander P Leff, Professor University College, London
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04570215    
Other Study ID Numbers: 18/0071
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
Digital Therapy
Digital intervention
Therapy app
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders