Condition category
Mental and Behavioural Disorders
Date applied
28/08/2007
Date assigned
16/10/2007
Last edited
01/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.projekt-ida.de/

Contact information

Type

Scientific

Primary contact

Prof Elmar Graessel

ORCID ID

Contact details

Psychiatrische und Psychotherapeutische Klinik
Universitatsklinikum Erlangen
Schwabachanlage 6
Erlangen
91054
Germany

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

http://www.aok.de/bundesweit/

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes