Danish Alzheimer Intervention StudY
| ISRCTN | ISRCTN74848736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74848736 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Neurology
Rigshospitalet, Section 6702
Copenhagen University Hospital
9 Blegdamsvej
Copenhagen
2100
Denmark
| Phone | +45 (0) 35 45 25 80 |
|---|---|
| waldemar@dadlnet.dk |
Study information
| Study design | Multi-center, single-blind, controlled randomised trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/03/2004 |
| Completion date | 21/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
2100
Denmark
Sponsor information
Memory Disorders Research Group (Denmark)
Research organisation
Research organisation
Department of Neurology
Rigshospitalet, Section 6702
Copenhagen University Hospital
9 Blegdamsvej
Copenhagen
2100
Denmark
| Phone | +45 (0) 35 45 25 80 |
|---|---|
| waldemar@dadlnet.dk | |
| Website | http://www.hukommelsesklinikken.dk |
"ROR" |
https://ror.org/03mchdq19 |
Funders
Funder type
Government
The National Board of Social Services
No information available
The Danish Ministry of Social Affairs
No information available
The Ministry of Health
No information available
The Danish Health Foundation
No information available
The Hospital Cooperation for Copenhagen
No information available
The Danish Alzheimer Foundation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | |
| Other publications | 22/12/2010 | Yes | No | ||
| Results article | results | 17/07/2012 | Yes | No |
