Dementia care initiative in primary practice (German title: Initiative Demenzversorgung in der Allgemeinmedizin)
| ISRCTN | ISRCTN68329593 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68329593 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Psychiatrische und Psychotherapeutische Klinik
Universitatsklinikum Erlangen
Schwabachanlage 6
Erlangen
91054
Germany
Study information
| 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 |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| 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 | 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 study start date | 25/06/2005 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | 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) |
| 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
91054
Germany
Sponsor information
Federal Association of the Statutory Regional Health Insurance Fund (Allgemeine Ortskrankenkasse [AOK]) (Germany)
Government
Government
Kortrijker Strasse 1
Bonn
53177
Germany
| Website | http://www.aok.de/bundesweit/ |
|---|---|
"ROR" |
https://ror.org/004cmqw89 |
Funders
Funder type
Industry
The study is jointly and equally funded by:
No information available
The statutory health insurance AOK Bavaria (Germany)
No information available
The Federal Association of the AOK (Germany)
No information available
Pfizer Deutschland (Germany) - research-based pharmaceutical company
No information available
EISAI GmbH (Germany) - research-based pharmaceutical company
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | study design and baseline data report | 01/05/2007 | Yes | No | |
| Protocol article | protocol | 06/06/2009 | Yes | No | |
| Results article | results | 18/11/2010 | Yes | No |
