Condition category
Mental and Behavioural Disorders
Date applied
31/08/2016
Date assigned
01/09/2016
Last edited
01/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.pflegetab.de

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

15/03/2017

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

https://www.gkv-spitzenverband.de

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

Publication citations

Additional files

Editorial Notes