Dementia care initiative in primary practice (German title: Initiative Demenzversorgung in der Allgemeinmedizin)

ISRCTN	ISRCTN68329593
DOI	https://doi.org/10.1186/ISRCTN68329593
Protocol serial number	N/A
Sponsor	Federal Association of the Statutory Regional Health Insurance Fund (Allgemeine Ortskrankenkasse [AOK]) (Germany)
Funders	The study is jointly and equally funded by:, The statutory health insurance AOK Bavaria (Germany), The Federal Association of the AOK (Germany), Pfizer Deutschland (Germany) - research-based pharmaceutical company, EISAI GmbH (Germany) - research-based pharmaceutical company

Submission date: 28/08/2007
Registration date: 16/10/2007
Last edited: 01/02/2011

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Elmar Graessel
Scientific

Psychiatrische und Psychotherapeutische Klinik
Universitatsklinikum Erlangen
Schwabachanlage 6
Erlangen
91054
Germany

Study information

Primary study design	Interventional
Study design	Three armed cluster-randomised trial with recruitment by 220 GPs (clusters) and an intervention/follow-up period of two years. Observer blind assessment of secondary outcomes.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	IDA
Study objectives	The main research hypothesis is that for dementia patients still living at home a complex intervention consisting of a training of General Practitioners (GPs) in evidence based treatment, of the provision of caregiver support groups, and of actively approaching family counselling, can prolong time to nursing home placement in comparison to usual care.
Ethics approval(s)	Ethics approval received from the Ethics board of the Bavarian Chamber of Physicians (Bayerische Landesarztekammer) on the 30th May 2005 (ref: 05029).
Health condition(s) or problem(s) studied	Mild to moderate dementia
Intervention	Control group: usual care (GPs receive only training in dementia diagnosis and in study procedures) Intervention group 1: GPs receive additional training in evidence based dementia treatment, caregivers are offered participation in dementia caregiver support groups Intervention group 2: as in intervention group 1 plus actively approaching family counselling Training for the GPs had a duration of 0.5 days for the control group and 1 day for the two intervention groups. The caregiver support groups take place once a month. The contact frequency with the actively approaching family counselling is every 6 to 8 weeks. The total duration of follow-up is 2 years for all treatment arms.
Intervention type	Other
Primary outcome measure(s)	Time to nursing home placement (within two year intervention and follow-up period).
Key secondary outcome measure(s)	1. Subjective burden of informal caregivers (Burden Scale for Family Caregivers [BSFC]) 2. Quality of life of the patients (EuroQol-5D measure [EQ5D]) 3. Direct medical and non-medical costs (including informal care) 4. Cognitive functioning of the patients (MMSE) 5. Patients' ability to perform Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) (Barthel-Index, Nurses' Observation Scale for Geriatric patients [NOSGER] subscale IADL) Secondary outcomes are measured at one and two years after study entry.
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	900
Key inclusion criteria	General practitioners: 1. Participating in a study specific training 2. Located in the study region of Middle Franconia Patients: 1. Mild to moderate dementia (Mini-Mental State Examination [MMSE] between 10 and 23) 2. Member of the health insurance AOK 3. 65 years and older 4. Living at home 5. Having an informal caregiver who is willing to participate in study
Key exclusion criteria	1. Patients having a terminal illness 2. Nursing home placement is already planned 3. Patients not able or willing to give informed consent
Date of first enrolment	25/06/2005
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Germany

Study participating centre

Psychiatrische und Psychotherapeutische Klinik

Erlangen
91054
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/11/2010		Yes	No
Protocol article	protocol	06/06/2009		Yes	No
Other publications	study design and baseline data report	01/05/2007		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes