Welcome
Support Centre
01 November 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Danish Alzheimer Intervention StudY
ISRCTN ISRCTN74848736
DOI 10.1186/ISRCTN74848736
ClinicalTrials.gov identifier
EudraCT number
Public title Danish Alzheimer Intervention StudY
Scientific title
Acronym DAISY
Serial number at source N/A
Study hypothesis That early social support, education, and counselling for patients with Alzheimers Disease (AD) is cost-effective and improves quality of life and reduces depressive symptoms in patients and caregivers.
Lay summary Not provided at time of registration
Ethics approval Local Ethics Research Board approved on February 27, 2004 (reference number: KF 02-005/04).
Study design Multi-center, single-blind, controlled randomised trial.
Countries of recruitment Denmark
Disease/condition/study domain Dementia and Alzheimer's disease
Participants - inclusion criteria 1. Progressing degenerative dementia (meeting international criteria for either probable AD, mixed AD/Vascular Dementia [VaD], or Dementia with Lewy Bodies [DLB])
2. Diagnosis established or confirmed by central specialist unit (memory clinic) in each center
3. Diagnosed within 12 months prior to inclusion
4. Aged above 50 years
5. Mild dementia: Mini-Mental State Examination (MMSE) score of more than 20
6. Primary caregiver (with close contact) who are willing to participate
7. Living at home
8. Sufficient language proficiency in Danish for adequate participation in counselling, interviews and tests
9. Informed consent from patient and caregiver
Participants - exclusion criteria 1. Severe somatic or psychiatric co-morbidity, including impaired hearing or vision, which will significantly impair cooperation to the program
2. Participation in other intervention studies at inclusion or during the study will not be allowed
Anticipated start date 01/03/2004
Anticipated end date 21/08/2009
Status of trial Completed
Patient information material
Target number of participants 330
Interventions 1. Individualised counselling meetings (fixed and open agendas):
1.1. two meetings with patient and carer (on initiation and towards the end of the intervention),
1.2. two meetings with patient,
1.3. two meetings with carer,
1.4. one meeting with patient, carer, and family network.

2. Teaching course for patients, approximately 12 participants, five scheduled sessions, including at each session:
2.1. information about key issues, supported by written information, fixed and open agenda,
2.2. support group activity.

3. Teaching course for carers (will take place simultaneously with course for patients, in a separate location), approximately 12 participants, five scheduled sessions, including at each session:
3.1 formalised teaching course (centralised program, local teachers),
3.2. support group activity.

4. Telephone counselling: follow-up phone call from project coordinator to patient/carer every two to four weeks.

5. Log-book to be kept by patient and carer (separate books), may be used at counselling visits to set the agenda. To be kept by patient/carer.
Primary outcome measure(s) 1. Patient:
1.1. depressive symptoms (Cornellís depression scale)
1.2. proxy rated health related quality of life (Euro-QoL VAS)
1.3. MMSE

2. Caregiver:
2.1. depressive symptoms (Geriatric Depression Scale, GDS-30)
2.2. health related quality of life (Euro-QoL VAS)
Secondary outcome measure(s) 1. Health related quality of life in patient (patient and proxy rated EuroQoL 5D and VAS, and Quality of life Alzheimerís disease scale QOL-AD)
2. Health related quality of life in caregiver (EuroQoL 5D and VAS)
3. Behavioral symptoms: Neuropsychiatric Inventory Questionnaire (NPI-Q)
4. Activities of daily living (ADCS-ADL)
5. Insight scale
6. Resource utilisation in patient and carer (Resource Utilisation in Dementia, RUD)
7. Registry-based assessment of health care utilisation and key social and health related events during 12 months before inclusion and during follow-up time (minimum five years):
7.1. time to nursing home, placement and death
7.2. number of in-patient and out patient contacts in patient and carer
7.3. co-morbidity in patient and carer
8. Patient and carer satisfaction with intervention, public services and network questionnaire
9. Patient and carer knowledge and attitudes about key issues in dementia questionnaire
Sources of funding 1. The National Board of Social Services
2. The Danish Ministry of Social Affairs
3. The Ministry of Health
4. The Danish Health Foundation
5. The Hospital Cooperation for Copenhagen
6. The Danish Alzheimer Foundation
Trial website http://www.hukommelsesklinikken.dk
Publications 1. Protocol paper presented at the ICAD conference in Madrid July 2006:
Waldemar G, Waldorff F, Buss DV, Eckermann A, Keiding N, Rishoej S, Soerensen J, Soerensen LV, Vogel A. The Danish Alzheimer intervention study (DAISY): Rationale, design and baseline characteristics. Alzheimer's & Dementia 2006;2 (Suppl 1):S571
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19939249
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22807076
Contact name Prof  Gunhild  Waldemar
  Address Department of Neurology
Rigshospitalet, Section 6702
Copenhagen University Hospital
9 Blegdamsvej
  City/town Copenhagen
  Zip/Postcode 2100
  Country Denmark
  Tel +45 (0) 35 45 25 80
  Fax +45 (0) 35 45 24 46
  Email waldemar@dadlnet.dk
Sponsor Memory Disorders Research Group (Denmark)
  Address Department of Neurology
Rigshospitalet, Section 6702
Copenhagen University Hospital
9 Blegdamsvej
  City/town Copenhagen
  Zip/Postcode 2100
  Country Denmark
  Tel +45 (0) 35 45 25 80
  Fax +45 (0) 35 45 24 46
  Email waldemar@dadlnet.dk
  Sponsor website: http://www.hukommelsesklinikken.dk
Date applied 16/08/2006
Last edited 19/09/2012
Date ISRCTN assigned 01/09/2006
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.