Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
IDA
Study hypothesis
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
Ethics approval received from the Ethics board of the Bavarian Chamber of Physicians (Bayerische Landesarztekammer) on the 30th May 2005 (ref: 05029).
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Time to nursing home placement (within two year intervention and follow-up period).
Secondary outcome measures
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.
Overall trial start date
25/06/2005
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
300 patients per study arm, 900 in total (as of the end of the study only 390 patients were recruited)
Participant 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
Recruitment start date
25/06/2005
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Psychiatrische und Psychotherapeutische Klinik
Erlangen
91054
Germany
Sponsor information
Organisation
Federal Association of the Statutory Regional Health Insurance Fund (Allgemeine Ortskrankenkasse [AOK]) (Germany)
Sponsor details
Kortrijker Strasse 1
Bonn
53177
Germany
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
The study is jointly and equally funded by:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The statutory health insurance AOK Bavaria (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Federal Association of the AOK (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer Deutschland (Germany) - research-based pharmaceutical company
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
EISAI GmbH (Germany) - research-based pharmaceutical company
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
1. 2007 study design and baseline data report in: http://www.ncbi.nlm.nih.gov/pubmed/17458361
2. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19500383
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21087474
Publication citations
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Study design and baseline data report
Lauterberg J, Grossfeld-Schmitz M, Ruckdäschel S, Neubauer S, Mehlig H, Gaudig M, Hruschka D, Vollmar HC, Holle R, Grässel E, [IDA project--concept and implementation of a cluster-randomized trial on dementia management in a general practice setting]., Z Arztl Fortbild Qualitatssich, 2007, 101, 1, 21-26.
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Protocol
Holle R, Grässel E, Ruckdäschel S, Wunder S, Mehlig H, Marx P, Pirk O, Butzlaff M, Kunz S, Lauterberg J, Dementia care initiative in primary practice: study protocol of a cluster randomized trial on dementia management in a general practice setting., BMC Health Serv Res, 2009, 9, 91, doi: 10.1186/1472-6963-9-91.
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Results
Donath C, Grässel E, Grossfeld-Schmitz M, Menn P, Lauterberg J, Wunder S, Marx P, Ruckdäschel S, Mehlig H, Holle R, Effects of general practitioner training and family support services on the care of home-dwelling dementia patients--results of a controlled cluster-randomized study., BMC Health Serv Res, 2010, 10, 314, doi: 10.1186/1472-6963-10-314.