DementiaNCT02908997
MindMate: A Study of a Reminder System for People With Dementia
A study testing MindMate in people with Dementia, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
A study to investigate the effectiveness of a reminder tool application at increasing performance on memory tasks in people with mild dementia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- MindMate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2017to 31 Jul 2018
- 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
- has a diagnosis of Mild Dementia, according to International Classification of Diseases (ICD) 10 Criteria
- has received the diagnosis from a psychiatrist
- owns a smart phone or tablet
- has a family member/partner/carer who is willing to monitor memory aid use
- has capacity to consent to being involved in the research
- is reporting memory difficulties that are affecting them in daily life
Who cannot join
- visual or auditory difficulties which cannot be corrected through the use of appropriate aids
- has a pre-existing neurological or severe psychiatric problem (e.g. bipolar disorder, psychosis)
- has a diagnosis of dementia that is considered to be in the moderate to severe stages
- those whose first language is not English
- those with a diagnosed or suspected developmental learning disability
- those who are currently using online or electronic memory aids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MindMate: A Single Case Experimental Design Study of a Reminder System for People With Mild Dementia
A study to investigate the effectiveness of a reminder tool application at increasing performance on memory tasks in people with mild dementia
Read the detailed description
Background
Memory difficulties are a core feature of dementia. These include difficulties remembering to do something at a specific time and place in the future (Prospective Memory). Although a range of electronic prospective memory aids currently exist (e.g. "Neuropage"), the evidence supporting their use among the dementia population remains limited. "Mindmate" is a recently developed mobile application that aims to support individuals with a diagnosis of dementia, improving self-management skills and quality of life.
Aims
This study will explore the effectiveness of "MindMate" reminder alerts delivered to a smart phone or tablet computer as a memory aid for people with a diagnosis of Mild Dementia.
Method
Three participants with a diagnosis of dementia, who are considered to be in the early stages and who report everyday prospective memory difficulties, will be recruited from Older People Community Mental Health teams within Greater Glasgow and Clyde. The participants will own a smart phone or tablet and will be living with a partner or family member who will also participate in the study. During the initial baseline phase, the partner or family member will monitor the number of pre defined tasks the participant remembered and forgot. The partner or family member will record this information on a weekly monitoring form and this phase will last between five to seven weeks. This will be followed by a five-week intervention phase where "MindMate" reminder alerts will be sent to the participant's phone or tablet. Again, tasks that require remembering will be identified prior to the intervention phase, and family members or carers will monitor their success on a form. Results will be analysed using visual inspection and Tau-U analysis.
Applications
This study will provide information on the effectiveness of a form of assistive technology at supporting people with a dementia, which could improve quality of life of those with a diagnosis.
- Conditions
- Dementia
- Being tested
- MindMate
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindMateOther
A dementia-specific mobile reminding application
| Study group | Role | What they receive |
|---|---|---|
| 5 week baseline | Experimental | 5 week baseline data collection followed by 6 week MindMate intervention Receives: Other: MindMate |
| 6 week baseline | Experimental | 6 week baseline data collection followed by 6 week MindMate intervention Receives: Other: MindMate |
| 7 week baseline | Experimental | 7 week baseline data collection followed by 6 week MindMate intervention Receives: Other: MindMate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory
Number of target events the participant remembered to complete
Measured: 6 weeks
Secondary outcomes (1)
Acceptability
Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire
Measured: Change from baseline to 6 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start17 Jan 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Jonathan Evans, BSc DClinPsy PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908997
- Sponsor's protocol ID
- GN16NE538
- Status last verified
- Nov 2018
- First submitted
- 19 Sep 2016
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MindMate: A Single Case Experimental Design Study of a Reminder System for People With Mild Dementia
- ClinicalTrials.gov ID
- NCT02908997
- Acronym / sponsor ID
- GN16NE538
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 21 Sep 2016 (estimated)
- 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.
A study to investigate the effectiveness of a reminder tool application at increasing performance on memory tasks in people with mild dementia
Detailed description
Background
Memory difficulties are a core feature of dementia. These include difficulties remembering to do something at a specific time and place in the future (Prospective Memory). Although a range of electronic prospective memory aids currently exist (e.g. "Neuropage"), the evidence supporting their use among the dementia population remains limited. "Mindmate" is a recently developed mobile application that aims to support individuals with a diagnosis of dementia, improving self-management skills and quality of life.
Aims
This study will explore the effectiveness of "MindMate" reminder alerts delivered to a smart phone or tablet computer as a memory aid for people with a diagnosis of Mild Dementia.
Method
Three participants with a diagnosis of dementia, who are considered to be in the early stages and who report everyday prospective memory difficulties, will be recruited from Older People Community Mental Health teams within Greater Glasgow and Clyde. The participants will own a smart phone or tablet and will be living with a partner or family member who will also participate in the study. During the initial baseline phase, the partner or family member will monitor the number of pre defined tasks the participant remembered and forgot. The partner or family member will record this information on a weekly monitoring form and this phase will last between five to seven weeks. This will be followed by a five-week intervention phase where "MindMate" reminder alerts will be sent to the participant's phone or tablet. Again, tasks that require remembering will be identified prior to the intervention phase, and family members or carers will monitor their success on a form. Results will be analysed using visual inspection and Tau-U analysis.
Applications
This study will provide information on the effectiveness of a form of assistive technology at supporting people with a dementia, which could improve quality of life of those with a diagnosis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5 week baseline | Experimental | Other: MindMate5 week baseline data collection followed by 6 week MindMate intervention |
| 6 week baseline | Experimental | Other: MindMate6 week baseline data collection followed by 6 week MindMate intervention |
| 7 week baseline | Experimental | Other: MindMate7 week baseline data collection followed by 6 week MindMate intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- has a diagnosis of Mild Dementia, according to International Classification of Diseases (ICD) 10 Criteria
- has received the diagnosis from a psychiatrist
- owns a smart phone or tablet
- has a family member/partner/carer who is willing to monitor memory aid use
- has capacity to consent to being involved in the research
Key exclusion criteria (6 listed)
- visual or auditory difficulties which cannot be corrected through the use of appropriate aids
- has a pre-existing neurological or severe psychiatric problem (e.g. bipolar disorder, psychosis)
- has a diagnosis of dementia that is considered to be in the moderate to severe stages
- those whose first language is not English
- those with a diagnosed or suspected developmental learning disability
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 |
|---|---|---|
| MindMateA dementia-specific mobile reminding application | Other | 5 week baseline, 6 week baseline, 7 week baseline |
Primary outcome
Memory
Time frame: 6 weeks
Number of target events the participant remembered to complete
1 secondary outcome
Acceptability
Time frame: Change from baseline to 6 week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: No
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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 Evans, BSc DClinPsy PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MindMate in people with Dementia, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 6 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: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory (time frame: 6 weeks). 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 6 Nov 2018.