Clinical trial NCT04026061: Pilot Study Person-centred Tablet Intervention
Official title: Randomised Controlled Feasibility Study Into FindMyApps; First Evaluation of a Tablet Intervention to Promote Self-management and Meaningful Activities in People With Mild Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Mobile Applications
Computers
Neurological Rehabilitation
Activities of Daily Living
Keywords: Medical Research Framework
Hand-held touchscreen devices
Self-management
Meaningful activities
Lead sponsor: Saxion University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: University of Twente
name: Radboud University Medical Center
name: Amsterdam UMC, location VUmc
First posted: 2019-07-19
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: First evaluation of FindMyApps, a tablet intervention consisting of a selection tool for usable apps for self-management and meaningful activities and a training that supports informal carers to help people with dementia to learn how to use the tablet and the tool.

Detailed description: Testing the feasibility and mechanism of impact of FindMyApps, a tablet intervention consisting of a selection tool to help persons with dementia find usable apps for self-management and meaningful activities and a training that supports informal carers to employ errorless learning principles to help people with dementia to learn how to use the tablet and the tool.

An exploratory pilot randomized controlled trial was carried out with a mixed-methods design. Twenty persons with mild dementia and carer dyads were randomly assigned to the FindMyApps group (n = 10) that used the FindMyApps training and selection tool, or a control condition that just got a tablet (n = 10). After informal carers had received the training, the dyads in the experimental group started with the three-month intervention. Pre and post-test measurements consisted of questionnaires and post-test semi-structured interviews.

Eligibility criteria: Inclusion Criteria:

* Eligible dyads had to be community dwelling.
* Persons with dementia had Mild Cognitive Impairment or mild dementia with a score of 3 to 4 on the Global Deterioration Scale (GDS; 45), with or without a confirmed diagnosis.
* Availability of an informal carer or volunteer to provide support.

Exclusion Criteria:

* Participation in another intervention trial
* Severe visual and/or physical impairment.

Primary outcomes:
measure: Self-management abilities people with dementia
timeFrame: At baseline and post-intervention at 3 months follow up
measure: Participation in daily and social activities people with dementia
timeFrame: At baseline and post-intervention at 3 months follow up
measure: Participation in daily and social activities people with dementia
timeFrame: At baseline and post-intervention at 3 months follow up
measure: Feeling of competence informal carers
timeFrame: At baseline and post-intervention at 3 months follow up
Secondary outcomes:
measure: Perceived self-efficacy people with dementia
timeFrame: At baseline and post-intervention at 3 months follow up
measure: Perceived autonomy people with dementia
timeFrame: At baseline and post-intervention at 3 months follow up
measure: Quality of life people with dementia
timeFrame: At baseline and post-intervention at 3 months follow up
measure: Positive care experiences informal carers
timeFrame: At baseline and post-intervention at 3 months follow up
measure: Quality of life informal carers
timeFrame: At baseline and post-intervention at 3 months follow up
measure: Quality of life informal carers
timeFrame: At baseline and post-intervention at 3 months follow up
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Saxion University of applied Sciences
state: Overijssel
Study officials:
affiliation: Saxion University of Applied Sciences
name: Yvonne Kerkhof, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kerkhof Y, Pelgrum-Keurhorst M, Mangiaracina F, Bergsma A, Vrauwdeunt G, Graff M, Droes RM. User-participatory development of FindMyApps; a tool to help people with mild dementia find supportive apps for self-management and meaningful activities. Digit Health. 2019 Mar 26;5:2055207618822942. doi: 10.1177/2055207618822942. eCollection 2019 Jan-Dec.
citation: Kerkhof YJ, Graff MJ, Bergsma A, de Vocht HH, Droes RM. Better self-management and meaningful activities thanks to tablets? Development of a person-centered program to support people with mild dementia and their carers through use of hand-held touch screen devices. Int Psychogeriatr. 2016 Nov;28(11):1917-1929. doi: 10.1017/S1041610216001071. Epub 2016 Jul 18.
citation: Kerkhof Y, Bergsma A, Graff M, Droes RM. Selecting apps for people with mild dementia: Identifying user requirements for apps enabling meaningful activities and self-management. J Rehabil Assist Technol Eng. 2017 Jun 2;4:2055668317710593. doi: 10.1177/2055668317710593. eCollection 2017 Jan-Dec.