Condition category
Mental and Behavioural Disorders
Date applied
01/04/2019
Date assigned
02/04/2019
Last edited
01/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

In Germany, the majority of people with dementia (PwD) are treated on an outpatient basis,
predominantly by general practitioners (GPs). However, outpatient care of PwD was repeatedly found to be unsustainable and deficient. While dementia guidelines give evidence-based treatment and care recommendations, these frequently lack adherence in care practice. Information and Communication Technologies may be a promising approach to improve guideline-based outpatient dementia care. The main objective of this study is the development and scientific evaluation of a tablet-based intervention that aims to improve outpatient dementia care by fostering guideline-based treatment. A two-arm cluster randomized controlled trial with an intervention group (tablet-based intervention) and a control group (treatment as usual plus information handbook), where clusters will be randomized at GP level, is planned. Patients will be recruited by GPs within the practice. The study’s primary outcome is adherence to dementia guideline recommendations at follow up (9 months). Secondary outcomes include various health outcomes such as general health status, depression or quality of life. An estimated sample size of 20 GP practices with 204 PwD and their caregivers from Berlin and the surrounding area will be recruited. Primary and secondary outcomes will be analyzed by an Intention-to-treat Analysis and using mixed models. The present study is expected to provide evidence-based results on the usage and implementation of a tablet-based intervention with the aim to improve guideline-based dementia care in the primary care sector.

Background and study aims:
In Germany, the majority of people with dementia (PwD) are treated on an outpatient basis, mostly by general practitioners (GPs). However, outpatient care of PwD was repeatedly found to be unsustainable and ineffective. There are dementia guidelines that give evidence-based treatment and care recommendations, but GPs often do not consult or follow the guidelines. Technologies such as tablets may be a good way to improve guideline-based outpatient dementia care. The aim of this study is to develop and test a tablet-based guide to improve outpatient dementia care by encouraging guideline-based treatment.

Who can participate?
General practitioners, patients with dementia and their informal caregivers

What does the study involve?
GPs are randomly allocated to an intervention group (tablet-based intervention) or a control group (treatment as usual plus information handbook). PwD will be recruited by GPs within the practice. In the control group, PwD and their caregivers will receive usual treatment plus an information handbook, whereas in the intervention group, the study’s participants will receive a tablet-based intervention that aims to promote guideline-based treatment and improve outpatient dementia care. At the start of the study and after 9 months, participants in both groups complete a range of questionnaires in order to assess how closely dementia guideline recommendations were followed, as well as the effects on the patients' and carers' health, such as general health status, depression or quality of life.

What are the possible benefits and risks of participating?
GPs can benefit from taking part in the study, as the tablet-based intervention might support GPs in providing the best care. Further, PwD and informal caregivers can benefit from the study, as the tablet-based app provides information and support on dementia management and may improve quality of outpatient dementia care. There are no risks involved with participating in this study.

Where is the study run from?
Charité- Universitätsmedizin Berlin (Germany)

When is the study starting and how long is it expected to run for?
April 2018 to April 2021

Who is funding the study?
German Innovation Fund

Who is the main contact?
1. Dr. Johanna Nordheim (scientific contact), johanna.nordheim@charite.de
2. Ms Sonia Lech (public contact), sonia.lech@charite.de

Trial website

http://www.demtab.de/

Contact information

Type

Scientific

Primary contact

Dr Johanna Nordheim

ORCID ID

Contact details

Institute of Medical Sociology and Rehabilitation Science
Charitéplatz 1
Berlin
10117
Germany
+49 30 450 529 085
johanna.nordheim@charite.de

Type

Public

Additional contact

Ms Sonia Lech

ORCID ID

Contact details

Institute of Medical Sociology and Rehabilitation Science
Charitéplatz 1
Berlin
10117
Germany
+49 30 450 529 115
sonia.lech@charite.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

01VSF17039

Study information

Scientific title

DemTab – Tablet-based outpatient care for people with dementia: Guideline-based treatment planning, personalized disease management and network-based care. A cluster randomized controlled trial

Acronym

DemTab

Study hypothesis

A tablet-based Intervention can improve GPs' adherence to dementia guideline recommendations at follow-up.

Ethics approval

Submitted 21/03/2019, Ethik Kommission der Charité – Universitätsmedizin Berlin (Charitéplatz 1, 10117 Berlin; +49 30 450 517 221; ethikkommission@charite.de)

Study design

Two-arm cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet.

Condition

Dementia

Intervention

Clusters will be randomized at GP level into an intervention group (tablet-based intervention) and a control group (treatment as usual plus information handbook). After randomization, in both groups, people with dementia (PwD) and informal caregivers will receive usual care during the study period. In the intervention group, PwD and caregivers will additionally receive a tablet-based intervention. In the control group, PwD and caregivers will additionally receive a handbook containing similar information as is available in the tablet intervention at the beginning of the trial.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Guideline adherence assessed using a checklist at baseline and at 9 months

Secondary outcome measures

Secondary outcomes at PwD level measured at baseline and at 9 months:
1. Dementia-related quality of life measured using the QOL-AD questionnaire
2. Health status measured using the EQ-5D-5L measure
3. Behavioural symptoms measured using the Neuropsychiatric Inventory (NPI-PH)
4. Cognition measured using the Mini-Mental State Examination (MMSE)
5. Functional independence assessed using the Barthel Index for Activities of Daily Living (ADL)
6. Dementia stage assessed using the Functional Assessment Staging Test (FAST)
7. Depression measured using the Depression in Old Age Scale (DIA-S)
8. Medication intake assessed using lists obtained from the GP as well as from the PwD and caregiver

Secondary outcomes at informal caregiver level measured at baseline and at 9 months:
1. Depression measured using the Geriatric Depression Scale (GDS)
2. Caregiver burden measured using the Burden Scale for Family Caregivers (BSFC)
3. Health status measured using the Short Form (36) Health Survey (SF-36)

Secondary outcome for all participants (GPs, PwD, caregivers) measured at 9 months:
1. Evaluation of the tablet-based application using the Technikaffinitaet – Elektronische Geraete (TA-EG, Technology Affinity – Electronic Devices) questionnaire, Usability Scale and AttrakDiff mini questionnaire as well as a set of self-developed items

Overall trial start date

15/04/2018

Overall trial end date

14/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

GPs:
1. Operates as a GP
2. Practice meets technical requirements (wifi connection available or can be installed)
3. Willing to participate in training
4. Signed cooperation agreement/informed consent to participate in the study

PwD:
5. Diagnosis of dementia: ICD-10 F00-F03, G30, G31.0 and G31.82
6. Living at home and receiving outpatient care
7. Informal caregiver available
8. Signed informed consent to participate in the study (possibly through legal advisors)

Informal caregiver:
9. Living with or regularly visiting PwD
10. Signed informed consent to participate in the study

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

GPs= 20, PwD and informal caregivers= 408 (204 each)

Participant exclusion criteria

GPs:
1. planned absence or closing of the practice longer than four weeks during the study period

PwD:
2. Other mental and behavioral disorders: ICD-10 Diagnosis F10-29 (except F10.1, F10.1, F17.1 or F17.2), F32.2 and F32.3
3. Planned hospital or rehabilitation stay longer than 4 weeks
4. Planned relocation to an inpatient care-facility or nursing home within the study period

Informal caregiver:
5. Planned absence longer than 8 weeks during the study period

Recruitment start date

01/05/2019

Recruitment end date

01/10/2019

Locations

Countries of recruitment

Germany

Trial participating centre

Institute of Medical Sociology and Rehabilitation Science, Charité - Universitätsmedizin
Charitéplatz 1
Berlin
10117
Germany

Trial participating centre

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

Sponsor information

Organisation

Charité - Universitätsmedizin Berlin

Sponsor details

Institute of Medical Sociology and Rehabilitation Science
Charitéplatz 1
Berlin
10117
Germany
+49 30 450 576399
michaela.bull@charite.de

Sponsor type

University/education

Website

https://medizinsoziologie-reha-wissenschaft.charite.de/

Funders

Funder type

Government

Funder name

German Innovation Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A scientific publication on the results of a requirement analysis is in preparation as of April 2019. A study protocol is in preparation as of April 2019. Results of the trial are planned to be published in a high-impact peer-reviewed journal after the study's end.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request. For further questions regarding the data please contact Johanna.nordheim@charite.de (principal investigator) and Sonia.lech@charite.de (study coordinator).

Intention to publish date

01/04/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/05/2019: Internal review. 12/04/2019: Internal review. 01/04/2019: Trial's existence confirmed by German Innovation Fund.