Danish Alzheimer Intervention StudY

ISRCTN	ISRCTN74848736
DOI	https://doi.org/10.1186/ISRCTN74848736
Protocol serial number	N/A
Sponsor	Memory Disorders Research Group (Denmark)
Funders	The National Board of Social Services, The Danish Ministry of Social Affairs, The Ministry of Health, The Danish Health Foundation, The Hospital Cooperation for Copenhagen, The Danish Alzheimer Foundation

Submission date: 16/08/2006
Registration date: 01/09/2006
Last edited: 19/09/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gunhild Waldemar
Scientific

Department of Neurology
Rigshospitalet, Section 6702
Copenhagen University Hospital
9 Blegdamsvej
Copenhagen
2100
Denmark

Phone	+45 (0) 35 45 25 80
Email	waldemar@dadlnet.dk

Study information

Primary study design	Interventional
Study design	Multi-center, single-blind, controlled randomised trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DAISY
Study objectives	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.
Ethics approval(s)	Local Ethics Research Board approved on February 27, 2004 (reference number: KF 02-005/04).
Health condition(s) or problem(s) studied	Dementia and Alzheimer's disease
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	1. Patient: 1.1. depressive symptoms (Cornells 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)
Key secondary outcome measure(s)	1. Health related quality of life in patient (patient and proxy rated EuroQoL 5D and VAS, and Quality of life Alzheimers 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
Completion date	21/08/2009

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	330
Key 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
Key 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
Date of first enrolment	01/03/2004
Date of final enrolment	21/08/2009

Locations

Countries of recruitment

Denmark

Study participating centre

Department of Neurology

Copenhagen
2100
Denmark

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	25/11/2009		Yes	No
Results article	results	17/07/2012		Yes	No
Other publications		22/12/2010		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes