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
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
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