Psychosocial support for patients suffering from dementia and their care giving partners

ISRCTN ISRCTN28074990
DOI https://doi.org/10.1186/ISRCTN28074990
Secondary identifying numbers N/A
Submission date
23/12/2011
Registration date
01/03/2012
Last edited
08/12/2015
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 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

Study website

Contact information

Dr Michael Rapp
Scientific

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

Study information

Study designInterventional randomised controlled multi-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet http://dyadem.charite.de [German]
Scientific titleFostering autonomy through a combined training and support program in patient/care giver DYAds in mild to moderate DEMentia (DYADEM): a randomized controlled trial
Study acronymDYADEM
Study objectivesDementia 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(s)Ethics Committee of Charité Medical University, Berlin [Charité Universitätsmedizin, Berlin – Ethikkommission] (Germany), 05/10/2011, ref: EA1/215/11
Health condition(s) or problem(s) studiedDementia
InterventionIntervention 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 typeOther
Primary outcome measureCombined standardized score of Quality of Life:
1. WHO-QoL (caregiver)
2. QOL-AD (dementia patient)
Secondary outcome measures1. 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 study start date01/02/2012
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsOverall recruitment of N = 240 dyads (120 dyads in each group)
Key inclusion criteria1. 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
Key exclusion criteria1. 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])
Date of first enrolment01/02/2012
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • Germany

Study participating centre

Charité - Universitätsmedizin Berlin
Berlin
10115
Germany

Sponsor information

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

Heinemannstr. 2
Bonn
53175
Germany

Email information@bmbf.bund.de
Website http://www.bmbf.de
ROR logo "ROR" https://ror.org/04pz7b180

Funders

Funder type

Government

Bundesministerium für Bildung und Forschung
Government organisation / National government
Alternative name(s)
Federal Ministry of Education and Research, BMBF
Location
Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan