Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Gunhild Waldemar
ORCID ID
Contact details
Department of Neurology
Rigshospitalet
Section 6702
Copenhagen University Hospital
9 Blegdamsvej
Copenhagen
2100
Denmark
+45 (0) 35 45 25 80
waldemar@dadlnet.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
DAISY
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.
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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)
Secondary outcome measures
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
Overall trial start date
01/03/2004
Overall trial end date
21/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
330
Participant 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
Recruitment start date
01/03/2004
Recruitment end date
21/08/2009
Locations
Countries of recruitment
Denmark
Trial participating centre
Department of Neurology
Copenhagen
2100
Denmark
Sponsor information
Organisation
Memory Disorders Research Group (Denmark)
Sponsor details
Department of Neurology
Rigshospitalet
Section 6702
Copenhagen University Hospital
9 Blegdamsvej
Copenhagen
2100
Denmark
+45 (0) 35 45 25 80
waldemar@dadlnet.dk
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
The National Board of Social Services
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Danish Ministry of Social Affairs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Ministry of Health
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Danish Health Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Hospital Cooperation for Copenhagen
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Danish Alzheimer Foundation
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
Basic results (scientific)
Publication list
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
Publication citations
-
Results
Søgaard R, Sørensen J, Waldorff FB, Eckermann A, Buss DV, Waldemar G, Private costs almost equal health care costs when intervening in mild Alzheimer's: a cohort study alongside the DAISY trial., BMC Health Serv Res, 2009, 9, 215, doi: 10.1186/1472-6963-9-215.
-
Results
Waldorff FB, Buss DV, Eckermann A, Rasmussen ML, Keiding N, Rishøj S, Siersma V, Sørensen J, Sørensen LV, Vogel A, Waldemar G, Efficacy of psychosocial intervention in patients with mild Alzheimer's disease: the multicentre, rater blinded, randomised Danish Alzheimer Intervention Study (DAISY)., BMJ, 2012, 345, e4693.