Condition category
Nervous System Diseases
Date applied
16/08/2006
Date assigned
01/09/2006
Last edited
19/09/2012
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.hukommelsesklinikken.dk

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 measures

1. Patient:
1.1. depressive symptoms (Cornell’s 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 Alzheimer’s 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

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

http://www.hukommelsesklinikken.dk

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes