Memory DisordersNCT02281617
Smart-device Apps as Memory Aids
An observational study of Memory Disorders, run by King's College London.
Trial summary
Patients experience problems with their memories from a variety of causes. There has been much work showing that the use of low tech devices, such as notebooks or diaries, can help patients remain independent. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Memory Disorders
- What is being tested?
- Smart-device apps as memory aids
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2017
- Phase
- Observational
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults attending an NHS memory clinic with fluent English and in possession of a smart-phone or tablet
Who may be able to join
- Subjective memory problems
- Fluent English
- Owns a smartphone or tablet
- sufficient motor skills to operate the smartphone or tablet
- sufficient eyesight to see the smartphone or tablet
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Patients experience problems with their memories from a variety of causes. There has been much work showing that the use of low tech devices, such as notebooks or diaries, can help patients remain independent. More recently, the use of electronic devices, such as digital voice recorders or pagers, has proved equally beneficial. Many of functions of memory aids could potentially be carried out by a smartphone or tablet using inbuilt functions such as a calendar or maps, as well as through downloadable apps, such as medication reminders. The investigators have surveyed the investigators patients to show that many of them already own smartphones and this number has dramatically increased in the last year. This project aims to investigate the feasibility and efficacy of using smartphone and tablet apps as memory aids in a clinical setting.
Read the detailed description
Purpose and design
This study will trial the use of smartphones and apps as memory aids with patients who have memory problems. There have been some case study reports in the literature but the investigators would like to use this study to investigate how feasible it is to offer these kinds of support within an NHS memory aids service.
Recruitment
Patients (and their relatives/carers, where relevant)will be recruited from those already referred to the Memory Aids Service run within the Neuropsychiatry and Memory Disorders Clinic at St Thomas's Hospital, within the South London and Maudsley NHS Foundation Trust. It is made clear in the Participant Information Sheet (one for patients and one for relatives/carers) that participation is voluntary and if patients do not want to take part, they will still receive personalised help and advice in the Memory Aids Service.
Inclusion/Exclusion
This project will be offered to patients who own their own smartphone; the project is unable to support costs of buying smartphones for patients and paying for any data usage. Patients who do not have smartphones will still receive memory aids support, but instead will receive help as is standardly given using other memory aids.Patients will be excluded if they do not have adequate levels of English or motor skills to use the apps.
Consent
Patients will be identified as possible participants during their routine memory aids assessment clinic visit by a member of the clinical care team. Only those with capacity to consent will be invited to take part. Those interested in taking part will be given a patient information sheet at the end of their assessment appointment (as will their relatives/carers where relevant) and the study will be briefly explained orally. Patients (and their relatives/carers) who do decide to participate will sign the consent form at the beginning of their next Memory Aids appointment and it will be stressed that participation is voluntary and they can withdraw at any time.
Confidentiality
Access to clinical data (pre- and post- intervention memory, mood, functioning, goal and carer stress scores, neuropsychological test scores and interview transcripts) will be restricted to those in the clinical care team until data is fully anonymised. Patients will be asked for consent for their data to be used for the study and a specific point on the informed consent form should be initialled to allow this.
Risks, burdens and benefits
The investigators hope that patients will find benefits in using smartphones as memory aids. The investigators will pay for any apps that are selected to use with them and offer instructions. Use of electronic aids and alarms on phones is well practised within the existing memory aids service. This project adds a semi-structured interview and follow-up phone call and therefore a limited burden for research participants and in some cases their relatives/carers. Since the intervention is non-invasive, the risk to participants is very low.
- Conditions
- Memory Disorders
- Being tested
- Smart-device apps as memory aids
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart-device apps as memory aidsBehavioural
Patients will be taught to use software running on smartphones and smart tablets to help compensate for memory difficulties
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective and Retrospective Memory Questionnaire PRMQ
Subjective memory questionnaire
Measured: End of intervention, on average 2 months
Meta-memory questionnaire MMQ
Questionnaire about beliefs about memory, problems and strategies
Measured: End of intervention, on average 2 months
Hospital Anxiety and Depression Inventory HADS
Questionnaire about anxiety and depression
Measured: End of intervention, on average 2 months
Revised carer stress index
Questionnaire about carer stress
Measured: End of intervention, on average 2 months
Semi-structured interview
Semi-structured interview about usability and usefulness of memory aid apps
Measured: End of intervention, on average 2 months
Brief phone call
Brief phone call to ask which apps are still being used
Measured: 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Memory DisordersStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Maudsley Charity
- Responsible party
- Sponsor
- Investigators
- Jennifer Liebscher, MA, Study director, South London and Maudsley NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281617
- Sponsor's protocol ID
- 139664
- Status last verified
- Oct 2014
- First submitted
- 28 Oct 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Migo EM, Haynes BI, Harris L, Friedner K, Humphreys K, Kopelman MD. mHealth and memory aids: levels of smartphone ownership in patients. J Ment Health. 2015;24(5):266-70. doi: 10.3109/09638237.2014.951479. Epub 2014 Sep 4.
PubMed 25188922
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart-device Apps as Memory Aids
- ClinicalTrials.gov ID
- NCT02281617
- Acronym / sponsor ID
- 139664
- Conditions
- Memory Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Maudsley Charity
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Nov 2014 (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.
Patients experience problems with their memories from a variety of causes. There has been much work showing that the use of low tech devices, such as notebooks or diaries, can help patients remain independent. More recently, the use of electronic devices, such as digital voice recorders or pagers, has proved equally beneficial. Many of functions of memory aids could potentially be carried out by a smartphone or tablet using inbuilt functions such as a calendar or maps, as well as through downloadable apps, such as medication reminders. The investigators have surveyed the investigators patients to show that many of them already own smartphones and this number has dramatically increased in the last year. This project aims to investigate the feasibility and efficacy of using smartphone and tablet apps as memory aids in a clinical setting.
Detailed description
Purpose and design
This study will trial the use of smartphones and apps as memory aids with patients who have memory problems. There have been some case study reports in the literature but the investigators would like to use this study to investigate how feasible it is to offer these kinds of support within an NHS memory aids service.
Recruitment
Patients (and their relatives/carers, where relevant)will be recruited from those already referred to the Memory Aids Service run within the Neuropsychiatry and Memory Disorders Clinic at St Thomas's Hospital, within the South London and Maudsley NHS Foundation Trust. It is made clear in the Participant Information Sheet (one for patients and one for relatives/carers) that participation is voluntary and if patients do not want to take part, they will still receive personalised help and advice in the Memory Aids Service.
Inclusion/Exclusion
This project will be offered to patients who own their own smartphone; the project is unable to support costs of buying smartphones for patients and paying for any data usage. Patients who do not have smartphones will still receive memory aids support, but instead will receive help as is standardly given using other memory aids.Patients will be excluded if they do not have adequate levels of English or motor skills to use the apps.
Consent
Patients will be identified as possible participants during their routine memory aids assessment clinic visit by a member of the clinical care team. Only those with capacity to consent will be invited to take part. Those interested in taking part will be given a patient information sheet at the end of their assessment appointment (as will their relatives/carers where relevant) and the study will be briefly explained orally. Patients (and their relatives/carers) who do decide to participate will sign the consent form at the beginning of their next Memory Aids appointment and it will be stressed that participation is voluntary and they can withdraw at any time.
Confidentiality
Access to clinical data (pre- and post- intervention memory, mood, functioning, goal and carer stress scores, neuropsychological test scores and interview transcripts) will be restricted to those in the clinical care team until data is fully anonymised. Patients will be asked for consent for their data to be used for the study and a specific point on the informed consent form should be initialled to allow this.
Risks, burdens and benefits
The investigators hope that patients will find benefits in using smartphones as memory aids. The investigators will pay for any apps that are selected to use with them and offer instructions. Use of electronic aids and alarms on phones is well practised within the existing memory aids service. This project adds a semi-structured interview and follow-up phone call and therefore a limited burden for research participants and in some cases their relatives/carers. Since the intervention is non-invasive, the risk to participants is very low.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults attending an NHS memory clinic with fluent English and in possession of a smart-phone or tablet
Key inclusion criteria (5 listed)
- Subjective memory problems
- Fluent English
- Owns a smartphone or tablet
- sufficient motor skills to operate the smartphone or tablet
- sufficient eyesight to see the smartphone or tablet
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Smart-device apps as memory aidsPatients will be taught to use software running on smartphones and smart tablets to help compensate for memory difficulties | Behavioural | – |
Primary outcome
Prospective and Retrospective Memory Questionnaire PRMQ
Time frame: End of intervention, on average 2 months
Subjective memory questionnaire
Meta-memory questionnaire MMQ
Time frame: End of intervention, on average 2 months
Questionnaire about beliefs about memory, problems and strategies
Hospital Anxiety and Depression Inventory HADS
Time frame: End of intervention, on average 2 months
Questionnaire about anxiety and depression
Revised carer stress index
Time frame: End of intervention, on average 2 months
Questionnaire about carer stress
Semi-structured interview
Time frame: End of intervention, on average 2 months
Semi-structured interview about usability and usefulness of memory aid apps
Brief phone call
Time frame: 1 year post treatment
Brief phone call to ask which apps are still being used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
- Background: PubMed 25188922Migo EM, Haynes BI, Harris L, Friedner K, Humphreys K, Kopelman MD. mHealth and memory aids: levels of smartphone ownership in patients. J Ment Health. 2015;24(5):266-70. doi: 10.3109/09638237.2014.951479. Epub 2014 Sep 4.
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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.
Jennifer Liebscher, MA study director
South London and Maudsley NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Memory Disorders, run by King's College London.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kate J Humphreys, PhD (+44 (0) 2071885402, kate.humphreys@slam.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective and Retrospective Memory Questionnaire PRMQ (time frame: End of intervention, on average 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02281617, which also lists 1 linked publication.
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 3 Nov 2014.