Plain English Summary
Background and study aims
Dementia is a common condition in the aging population. People with dementia have difficulties with mental processes such as memory, language, reasoning and identifying people and objects, which become progressively worst over time. There are a range of different types of dementia, but the most common is Alzheimer’s disease (AD). Around 65% of nursing home residents in Germany suffer from Alzheimer’s disease and related disorders (ADRD). Therefore, psychosocial interventions (ways of supporting patients to overcome challenges and maintain good mental health) for dealing with ADRD related symptoms play an important role in residential care. Recent findings suggest that Information and Communication Technologies (ICTs) can be effective tools for supporting dementia care delivery. However, further in-depth research is needed to find out the specific benefits of ICTs in dementia care. The aim of this study is to investigate the effects of a tablet-computer-based program on quality of life and behavior in nursing home residents with dementia.
Who can participate?
Berlin nursing home residents with dementia.
What does the study involve?
Participating nursing homes are randomly allocated to one of two groups. Over a period of eight weeks, residents with ADRD in the first group take part in three supervised 30-minute tablet sessions per week which involve using tablet applications (apps) that target mental processes and functional abilities, while helping patients to control their emotions. Residents of nursing homes in the second group, complete the same sessions without the use of tablets. Sessions instead involve enjoyable activities such as drawing, singing, playing board games or taking short walks, with a trained caregiver. At the start of the study and then again after eight weeks, participants in both groups complete a range of questionnaires in order to assess their quality of life, thought processes and behavioural symptoms.
What are the possible benefits and risks of participating?
Participants can benefit from taking part in the sessions offered, as they may help to improve their quality of life, thought processes and behavioural symptoms. There are no risks involved with participating in this study.
Where is the study run from?
Ten nursing homes located in Berlin (Germany)
When is the study starting and how long is it expected to run for?
February 2016 to March 2017
Who is funding the study?
GKV Spitzenverband (Germany)
Who is the main contact?
1. Dr Johanna Nordheim (scientific)
2. Ms Julie O’Sullivan (scientific)
3. Dr Jan-Niklas Antons (scientific)
jan-niklas.antons@tu-berlin.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Johanna Nordheim
ORCID ID
Contact details
Institut für Medinzinsche Soziologie
Luisenstraße 13
Berlin
10117
Germany
Type
Scientific
Additional contact
Ms Julie O'Sullivan
ORCID ID
http://orcid.org/0000-0002-8991-9966
Contact details
Insitut für Medizinsche Soziologie
Luisenstraße 13
Berlin
10117
Germany
+49 30 450 529113
julie.osullivan@charite.de
Type
Scientific
Additional contact
Dr Jan-Niklas Antons
ORCID ID
http://orcid.org/0000-0002-2786-9262
Contact details
Technische Universität Berlin
Faculty IV Electrical Engineering and Computer Science
Quality and Usability Lab
Telekom Innovation Laboratories
Ernst-Reuter-Platz 7
Berlin
10587
Germany
+49 30 8353 58 377
jan-niklas.antons@tu-berlin.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A Tablet-based intervention for Nursing Home Residents suffering from Alzheimer’s Disease and Related Disorders: A cluster-randomised controlled trial
Acronym
PflegeTab
Study hypothesis
A tablet-based psychosocial intervention can improve engagement, quality of life and behavioral symptoms in nursing home residents suffering from Alzheimer's disease and related disorders.
Ethics approval
Ethics board of Charité Universitätsmedizin Berlin, 25/02/2016, ref: EA1/013/16
Study design
Multi-centre cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet (available in German)
Condition
Alzheimers disease and related disorders (dementia)
Intervention
Participants are randomised at nursing home level (cluster-randomisation) to one of two groups.
Intervention group: Over a period of 8 weeks, experimental group participants will engage in 3 supervised 30-minute tablet sessions per week using adaptive tablet-applications targeting cognitive and functional abilities and supporting emotional self-regulation. The applications were developed for the purpose of this study and run on a standard tablet device (iPad). A trained caregiver will guide and support the participants while they interact with the tablet.
Control group: Participants will receive an equal amount of individual activation sessions without tablets (3 sessions per week for a period of 8 weeks). During control group sessions, enjoyable activities such as drawing, singing, board games or short walks will be conducted. Control group sessions will also be accompanied by a trained caregiver.
All questionnaire data (primary and secondary outcomes) will be collected from participants at baseline and after an intervention period (tablet-based activation vs. individual activation without tablets) of 8 weeks. No further follow-ups are planned in this study.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Engagement is measured using the Adult Education Survey (AES) at baseline and after 8 weeks.
Secondary outcome measures
1. Dementia-related quality of life is measured using the QOL-AD questionnaire (patient) and the Qualidem scale (caregiver) at baseline and after 8 weeks
2. Behavioural symptoms are measured using the Neuropsychiatric Inventory – Nursing Home Version (NPI-NH) questionnaire at baseline and after 8 weeks
3. Cognition is measured using the Mini-Mental State Examination (MMSE) and the Alters-Konzentrations-Test (AKT) at baseline and after 8 weeks
4. Autonomy/iADL is measured using the Barthel Index and the Functional Assessment Staging Test (FAST) questionnaire at baseline and after 8 weeks
5. Depression is measured using the Geriatric Depression Scale (GDS) at baseline and after 8 weeks
6. Engagement is measured using behavioural data (number of solved tasks, number of mistouches, number of errors, etc.) assessed via tablet during each activation session (intervention group only)
7. Intensive longitudinal assessments are undertaken using a short version of the Qualidem scale administered before and after every single activation session in both intervention and control group
Overall trial start date
01/02/2016
Overall trial end date
15/04/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Nursing home residents diagnosed with dementia (MMST < 24)
2. Informed consent of participant (and legal guardian)
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
N=240 (10 clusters w/24 participants each)
Participant exclusion criteria
1. Other chronic psychiatric conditions
2. Resident for less than 4 weeks
Recruitment start date
01/06/2016
Recruitment end date
31/01/2017
Locations
Countries of recruitment
Germany
Trial participating centre
Charité Universitätsmedizin Berlin Insitut für Medinzinsche Soziologie
Luisenstr. 13
Berlin
10117
Germany
Trial participating centre
Domicil Seniorenpflegeheim Frobenstraße GmbH
Berlin
12249
Germany
Trial participating centre
Domicil Seniorenpflegeheim Afrikanische Straße GmbH
Berlin
13351
Germany
Trial participating centre
Domicil Seniorenpflegeheim Bergstraße GmbH
Berlin
12169
Germany
Trial participating centre
Domicil Seniorenpflegeheim Müllerstraße GmbH
Berlin
13349
Germany
Trial participating centre
Domicil Seniorenpflegeheim Residenzstraße GmbH
Berlin
13407
Germany
Trial participating centre
Domicil Seniorenpflegeheim Feuerbachstraße GmbH
Berlin
12163
Germany
Trial participating centre
Domicil Seniorenpflegeheim Gotlindestraße GmbH
Berlin
10365
Germany
Trial participating centre
Domicil Seniorenpflegeheim Am Frankfurter Tor GmbH
Berlin
10249
Germany
Trial participating centre
Domicil Seniorenpflegeheim Techowpromenade GmbH
Berlin
13347
Germany
Trial participating centre
Domicil Seniorenpflegeheim Baumschulenweg GmbH
Berlin
12437
Germany
Sponsor information
Organisation
GKV Spitzenverband
Sponsor details
Reinhardtstr. 28
Berlin
10117
Germany
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
GKV Spitzenverband
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
Intention to publish date
01/02/2018
Participant level data
Available on request
Results - basic reporting
Publication summary