|- candidate number||29350|
|- NTR Number||NTR7409|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-aug-2018|
|- Secondary IDs||WC2017-084 Amsterdam Public Health; Amsterdam UMC, location VU Medical Center|
|- Public Title||FindMyApps; Effectiveness and User satisfaction of a person-centred intervention to help people with mild dementia find and use suitable apps that support their self-management and social participation|
|- Scientific Title||FindMyApps; Effectiveness and User satisfaction of a person-centred intervention to help people with mild dementia find and use suitable apps that support their self-management and social participation|
|- Healt Condition(s) or Problem(s) studied||Psycho-social intervention, Dementia, Alzheimer's disease|
|- Inclusion criteria|| People with a diagnosis of Mild Cognitive Impairment (MCI) or with MILD dementia OR with an MMSE 25-18 or GDS 3 and 4.|
Living in the community
Living in the East and the West of the Netherlands
Highly motivated to learn how to use/to use a touchscreen device
|- Exclusion criteria|| People with severe dementia (MMSE <18)|
People with severe eye-sight problems or blindness
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2018|
|- planned closingdate||1-jan-2020|
|- Target number of participants||80|
|- Interventions||THE FINDMYAPPS INTERVENTION (EXPERIMENTAL GROUP)|
Dyads of people with MCI/mild dementia and their carer in the experimental group will use the tablet (either their own or given by the VUmc) with the FindMyApps programme and will receive training based on the error-less learning principles on how to use the tablet as well as the FindMyApps programme. After 3 months participants will be asked whether they want to continue to be part of the study. If so, participants will keep using the tablet for other 3 months. If they prefer to stop, participants who were given the tablet by the VUmc, will give the tablet back. From the start to follow-up, participants can make use of the helpdesk service in case of questions/problems with the tablet or apps.
USUAL CARE/TABLET USE (CONTROL GROUP)
Dyads of people with MCI/mild dementia will either use the tablet (their own tablet or a tablet provided by the VUmc) without FindMyApps and training on how to use the tablet (not based on the error-less learning method) will be delivered. Participants in the control group will receive a list of website in which they can find useful apps for self-management, social participation and meaningful activities. After 3 months they will be asked if they want to continue to use the tablet. If so, participants will keep using the tablet for other 3 months. If they prefer to stop, participants who were given the tablet by the VUmc, will give the tablet back. From the start to follow-up, participants can make use of the helpdesk service in case of questions/problems with the tablet or apps.
|- Primary outcome||Self-management and social participation of the person with dementia|
|- Secondary outcome|| For the person with dementia: experienced autonomy, self-efficacy, quality of life|
For the carer: sense of competence, positive care experience and quality of life.
|- Timepoints||The primary and the secondary outcome will be investigated by means of questionnaires.
Questionnaires will be investigated at baseline (T0), after 3 months the baseline (T1) and at follow-up (after 6 months the baseline, T2).|
Qualitative data will be also collected in a selected group of participants by means of semi-structured interviews at T1.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD student Floriana Mangiaracina|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Rose-Marie Drφes |
|- Sponsor/Initiator ||Amsterdam UMC, location VU Medical Centre (VUmc)|
(Source(s) of Monetary or Material Support)
|Marie Slodowska Curie, Stichting Hofje Codde & Van Beresteyn, Stichting tot Steun (VCVGZ)|
|- Brief summary||There is growing evidence that hand-held touch-screen devices (tablets) and applications (apps),
such as apps for timely medication intake, social contact and activities, can support people with mild
dementia to manage their life and engage in meaningful activities. Because not all people with
dementia are familiar with the use of tablets and not all apps are suitable for each individual, a
person-centred tablet intervention, called FindMyApps, was developed in co-creation with end users.
The intervention consists of a training to learn to use the tablet and a selection tool to help users find
apps for self-management and meaningful activities that fit their needs, wishes and abilities. This
study aims to evaluate the effectiveness and user satisfaction of tablet use supported by FindMyApps
compared to Usual tablet use (i.e. tablet use without the FindMyApps intervention) for improving,
among other outcomes, the self-management and social participation of the person with dementia.|
To this end a randomised control trial (RCT; pilot study) will be conducted with the following
(a) To pilot-test the effect of the FindMyApps intervention: for this purpose dyads of people
with mild dementia and Mild Cognitive Impairment and carers will be randomly assigned to
an experimental group receiving a tablet with the FindMyApps intervention or a control
group receiving Usual Care (tablet use without FindMyApps). Measurements will be
conducted before the intervention (T0), after 3 months intervention (T1) and at follow-up
(T2) 3 months after T1.
(b) To test the feasibility of the research protocol and to determine some important parameters
needed for a full randomized control trial.
(c) To conduct a process evaluation which will inventory the tablet/apps use and factors and
user experiences that might influence the intervention outcomes, tablet use and user
(d) To evaluate the user satisfaction: for this in the FindMyApps and Usual Care group at T1 and
T2 the satisfaction of dyads with tablet use will be investigated.
To collect data mixed methods will be used: questionnaires for the effect study and process
evaluation and semi-structured interview and data analytics for the process evaluation.
|- Main changes (audit trail)|
|- RECORD||1-aug-2018 - 10-aug-2018|