Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02281617
Other study ID # 139664
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 28, 2014
Last updated October 30, 2014
Start date December 2014
Est. completion date December 2017

Study information

Verified date October 2014
Source King's College London
Contact Kate J Humphreys, PhD
Phone +44 (0) 2071885402
Email kate.humphreys@slam.nhs.uk
Is FDA regulated No
Health authority England: NHS Health Research Authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Smart-device apps as memory aids
Patients will be taught to use software running on smartphones and smart tablets to help compensate for memory difficulties

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
King's College London Maudsley Charity

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prospective and Retrospective Memory Questionnaire PRMQ Subjective memory questionnaire End of intervention, on average 2 months No
Primary Meta-memory questionnaire MMQ Questionnaire about beliefs about memory, problems and strategies End of intervention, on average 2 months No
Primary Hospital Anxiety and Depression Inventory HADS Questionnaire about anxiety and depression End of intervention, on average 2 months No
Primary Revised carer stress index Questionnaire about carer stress End of intervention, on average 2 months No
Primary Semi-structured interview Semi-structured interview about usability and usefulness of memory aid apps End of intervention, on average 2 months No
Primary Brief phone call Brief phone call to ask which apps are still being used 1 year post treatment No
See also
  Status Clinical Trial Phase
Recruiting NCT03894254 - Predictive Factors of Autonomy Loss in Real-life Cohort N/A
Not yet recruiting NCT03507985 - Attention and Memory Disorders Related to Acute Morphine
Terminated NCT02521558 - Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease N/A
Completed NCT00355498 - Amyloid Plaque and Tangle Imaging in Aging and Dementia
Completed NCT00010920 - Preventing Cognitive Decline With Alternative Therapies Phase 3
Not yet recruiting NCT04079075 - Multiple Interventions to Prevent Cognitive Decline N/A
Completed NCT02185222 - Effect of Vitamin D on Cognitive Decline of Patients With Memory Complaint Phase 3
Completed NCT00289471 - Identifying Patients With Dementia in Primary Care N/A
Terminated NCT00548327 - The Effects of Atomoxetine on Cognition and Brain Function Based on Catechol-O-methyltransferase(COMT) Genotype Phase 2
Completed NCT00387062 - Computer-Based Training in Patients With Post-Chemotherapy Cognitive Impairment Phase 1
Completed NCT00403507 - Exercise Treatment of Mild-Stage Probable Alzheimer's Disease Phase 2
Completed NCT04587583 - WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers Phase 1/Phase 2
Completed NCT02843529 - Evaluation of a Computerized Complex Instrumental Activities of Daily Living Marker (NMI) N/A
Active, not recruiting NCT03205709 - Cognitive Training and Neuroplasticity in Mild Cognitive Impairment N/A
Recruiting NCT05509075 - Nutraceuticals and Functional Foods
Recruiting NCT05065450 - Amygdala Memory Enhancement N/A
Recruiting NCT05929144 - Optimization of MRI Sequences Used in the Study of Neurodegenerative Diseases N/A
Active, not recruiting NCT03661034 - Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study) N/A
Completed NCT02333942 - Dementia Signal Development Study of Nautilus NeuroWave TM for the Detection of Dementia
Completed NCT02236416 - Physical Exercise for Prevention of Dementia N/A