Condition category
Mental and Behavioural Disorders
Date applied
23/12/2011
Date assigned
01/03/2012
Last edited
08/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dementia is a broad category of brain diseases that cause a long-term gradual decrease in the ability to think and remember. As there is currently no cure, interventions to help patients and caregivers to handle daily life with dementia are gaining importance. This study tests an intervention in a population of community dwelling older adults suffering from dementia who are cared for by a partner or family member. The aim of the intervention is to strengthen their personal and shared skills to better cope with the daily hassles that occur due to dementia.

Who can participate?
Community-dwelling patients with mild to moderate dementia and their partner/family caregiver who lives with them.

What does the study involve?
Participants are randomly allocated into two groups. One group receives nine sessions of a psychosocial support program. The other group receives a standard dementia consultation.

What are the possible benefits and risks of participating?
The intervention should lead to preservation or an increase of the patients’ and caregivers’ quality of life, and delay nursing home placement. There are no risks for the patients.

Where is the study run from?
Charité - Universitätsmedizin Berlin, Germany.

Who is funding the study?
Federal German Ministry of Education and Research.

When is study starting and how long is it expected to run for?
January 2011 to December 2013.

Who is the main contact?
Dr Michael Rapp

Trial website

http://dyadem.charite.de

Contact information

Type

Scientific

Primary contact

Dr Michael Rapp

ORCID ID

Contact details

Charité - Universitätsmedizin Berlin
Geriatric Psychiatry Center
Psychiatric University Hospital St. Hedwig
Department of Psychiatry
Campus Mitte
Grosse Hamburger Str. 5-11
Berlin
10115
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Fostering autonomy through a combined training and support program in patient/care giver DYAds in mild to moderate DEMentia (DYADEM): a randomized controlled trial

Acronym

DYADEM

Study hypothesis

Dementia describes a group of symptoms affecting intellectual and social abilities severely enough to interfere with daily functioning. Among other causes of dementia, Alzheimer's disease is the most common cause. Although dementia is far more common in the geriatric population, it can occur before the age of 60.

Since there is no curative medical treatment available today, non-pharmacological interventions to enable patients and caregivers to handle daily life with dementia are gaining importance, especially in view of demographic changes.

Hypotheses:
1. A specific psychosocial intervention in a dyad (patient with dementia and their affiliated) is more effective in maintaining quality of life than “treatment as usual” (TAU)-dementia consulting.
2. A combined intervention targeting patient/caregiver dyads is able to delay nursing home placement in this population
3. How do external and internal resources moderate the association between the burden of being sick and autonomy / self-contentment in dyads?

Ethics approval

Ethics Committee of Charité Medical University, Berlin [Charité Universitätsmedizin, Berlin – Ethikkommission] (Germany), 05/10/2011, ref: EA1/215/11

Study design

Interventional randomised controlled multi-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

http://dyadem.charite.de [German]

Condition

Dementia

Intervention

Intervention group: 9 sessions including socio and psychotherapeutic modules
Control group: treatment as usual dementia consulting, information sheet

Treatment group gets 9 weekly/ two-weekly sessions (1 to 2 hours) during approximately 12 weeks.
Session 1: couple specific psychosocial anamnesis
Session 2: social therapy I (information about support, social network, activities)
Session 3: psychotherapy I (stress, dyadic coping)
Session 4: socio-therapeutic consolidation via telephone
Session 5: psychotherapy II (communication training)
Session 6: social therapy II (daily routine coping strategies)
Session 7: psychotherapy III (problem solving)
Session 8: socio-therapeutic consolidation via telephone
Session 9: post-processing

Control group receives treatment as usual plus information sheets and contact details of support providers; duration: approximately 1 hour.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Combined standardized score of Quality of Life:
1. WHO-QoL (caregiver)
2. QOL-AD (dementia patient)

Secondary outcome measures

1. Autonomy:
1.1. Activities of Daily Living (ADL)/ instrumental Activities of Daily Living (iADL)
1.2. Older Adults Overprotection Scale (OPSA)
1.3. Sense of Competence Questionnaire (SCQ)
2. Time to nursing home placement

Overall trial start date

01/02/2012

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Community dwelling, diagnosed patients with mild to moderate dementia and their partner/ family caregiver
2. Are living together in one domestic home in Berlin, Germany
3. Are willing to participate together with their partner in the intervention

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Overall recruitment of N = 240 dyads (120 dyads in each group)

Participant exclusion criteria

1. Modified-Modified Schober Test (MMST) <15
2. Patient or partner/ family caregiver suffers from other specific psychiatric diseases (mental and behavioural disorders due to psychoactive substance use [ICD-10 F10-29])

Recruitment start date

01/02/2012

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Germany

Trial participating centre

Charité - Universitätsmedizin Berlin
Berlin
10115
Germany

Sponsor information

Organisation

Federal German Ministry of Education and Research [Bundesministerium für Bildung und Forschung (BMBF)] (Germany)

Sponsor details

Heinemannstr. 2
Bonn
53175
Germany
-
information@bmbf.bund.de

Sponsor type

Government

Website

http://www.bmbf.de

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes