PflegeTab - A tablet-based approach for improving the level of well-being and quality of life in people affected by dementia

ISRCTN ISRCTN98947160
DOI https://doi.org/10.1186/ISRCTN98947160
Secondary identifying numbers N/A
Submission date
31/08/2016
Registration date
01/09/2016
Last edited
28/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Study website

Contact information

Dr Johanna Nordheim
Scientific

Institut für Medinzinsche Soziologie
Luisenstraße 13
Berlin
10117
Germany

Ms Julie O'Sullivan
Scientific

Insitut für Medizinsche Soziologie
Luisenstraße 13
Berlin
10117
Germany

ORCiD logoORCID ID 0000-0002-8991-9966
Phone +49 30 450 529113
Email julie.osullivan@charite.de
Dr Jan-Niklas Antons
Scientific

Technische Universität Berlin
Faculty IV Electrical Engineering and Computer Science
Quality and Usability Lab
Telekom Innovation Laboratories
Ernst-Reuter-Platz 7
Berlin
10587
Germany

ORCiD logoORCID ID 0000-0002-2786-9262
Phone +49 30 8353 58 377
Email jan-niklas.antons@tu-berlin.de

Study information

Study designMulti-centre cluster randomised controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet (available in German)
Scientific titleA Tablet-based intervention for Nursing Home Residents suffering from Alzheimer’s Disease and Related Disorders: A cluster-randomised controlled trial
Study acronymPflegeTab
Study objectivesA 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(s)Ethics board of Charité Universitätsmedizin Berlin, 25/02/2016, ref: EA1/013/16
Health condition(s) or problem(s) studiedAlzheimers disease and related disorders (dementia)
InterventionParticipants 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 typeBehavioural
Primary outcome measureEngagement is measured using the Adult Education Survey (AES) at baseline and after 8 weeks.
Secondary outcome measures1. 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 study start date01/02/2016
Completion date15/04/2018

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsN=240 (10 clusters w/24 participants each)
Key inclusion criteria1. Nursing home residents diagnosed with dementia (MMST < 24)
2. Informed consent of participant (and legal guardian)
Key exclusion criteria1. Other chronic psychiatric conditions
2. Resident for less than 4 weeks
Date of first enrolment01/06/2016
Date of final enrolment31/01/2017

Locations

Countries of recruitment

  • Germany

Study participating centres

Charité Universitätsmedizin Berlin Insitut für Medinzinsche Soziologie
Luisenstr. 13
Berlin
10117
Germany
Domicil Seniorenpflegeheim Frobenstraße GmbH
Berlin
12249
Germany
Domicil Seniorenpflegeheim Afrikanische Straße GmbH
Berlin
13351
Germany
Domicil Seniorenpflegeheim Bergstraße GmbH
Berlin
12169
Germany
Domicil Seniorenpflegeheim Müllerstraße GmbH
Berlin
13349
Germany
Domicil Seniorenpflegeheim Residenzstraße GmbH
Berlin
13407
Germany
Domicil Seniorenpflegeheim Feuerbachstraße GmbH
Berlin
12163
Germany
Domicil Seniorenpflegeheim Gotlindestraße GmbH
Berlin
10365
Germany
Domicil Seniorenpflegeheim Am Frankfurter Tor GmbH
Berlin
10249
Germany
Domicil Seniorenpflegeheim Techowpromenade GmbH
Berlin
13347
Germany
Domicil Seniorenpflegeheim Baumschulenweg GmbH
Berlin
12437
Germany

Sponsor information

GKV Spitzenverband
Government

Reinhardtstr. 28
Berlin
10117
Germany

Website https://www.gkv-spitzenverband.de
ROR logo "ROR" https://ror.org/03psr2094

Funders

Funder type

Government

GKV Spitzenverband

No information available

Results and Publications

Intention to publish date01/02/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications concordance of self- and informant-rated depressive symptoms 05/04/2022 07/04/2022 Yes No
Other publications validation of an eight-item version of the QUALIDEM 01/06/2020 28/10/2022 Yes No

Editorial Notes

28/10/2022: Publication reference added.
07/04/2022: Publication reference added.
12/03/2018: Overall trial end date changed from 15/03/2017 to 15/04/2018.