Efficacy of psychosocial intervention in patients with mild Alzheimer’s disease: the multicentre, rater blinded, randomised Danish Alzheimer Intervention Study (DAISY)

Waldorff, F. B.; Buss, D. V.; Eckermann, A.; Rasmussen, M. L. H.; Keiding, N.; Rishoj, S.; Siersma, V.; Sorensen, J.; Sorensen, L. V.; Vogel, A.; Waldemar, G.

doi:10.1136/bmj.e4693

Cited by 106Dementia and Cognitive Impairment ResearchNursing care and researchAlzheimer's disease research and treatments

Efficacy of psychosocial intervention in patients with mild Alzheimer’s disease: the multicentre, rater blinded, randomised Danish Alzheimer Intervention Study (DAISY)

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Waldorff, F. B., Buss, D. V., Eckermann, A., Rasmussen, M. L. H., Keiding, N., Rishoj, S., Siersma, V., Sorensen, J. +3 more·2012·BMJ

DOI 10.1136/bmj.e4693PMC PMC3398860

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Abstract

OBJECTIVE: To assess the efficacy at 12 months of an early psychosocial counselling and support programme for outpatients with mild Alzheimer's disease and their primary care givers. DESIGN: Multicentre, randomised, controlled, rater blinded trial. SETTING: Primary care and memory clinics in five Danish districts. PARTICIPANTS: 330 outpatients with mild Alzheimer's disease and their 330 primary care givers. INTERVENTIONS: Participating dyads (patient and primary care giver) were randomised to control support during follow-up or to control support plus DAISY intervention (multifaceted and semi-tailored counselling, education, and support). MAIN OUTCOME MEASURES: Primary outcomes at 12 months for patients were change from baseline in mini mental state examination (MMSE) score, Cornell depression scale score, and proxy rated European quality of life visual analogue scale (EQ-VAS) score. For care givers, outcomes were change from baseline in geriatric depression scale (GDS 30 items) score and EQ-VAS score. RESULTS: Because of multiple testing, statistical significance was set at an adjusted P limit of <0.0005. At 12 months there were no significant differences between the two allocation groups in changes from baseline in the primary and secondary outcomes. However, although non-significant with the adjusted P limit, a small difference was observed for one of the primary patient outcomes (Cornell depression scale score) in patients in favour of the DAISY intervention group before and after adjusting for attrition (P = 0.0146 and P = 0.0103 respectively). CONCLUSIONS: The multifaceted, semi-tailored intervention with counselling, education, and support for patients with mild Alzheimer's disease and their care givers did not have any significant effect beyond that with well structured follow-up support at 12 months after adjustment for multiple comparisons. The small positive effect found in the unadjusted primary outcome addressing depressive symptoms in patients may call for further research focusing on patients with Alzheimer's disease and comorbid depression. TRIAL REGISTRATION: ISRCTN74848736.

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Other recent psychosocial interventions have been ineffective for both carer psychological symptoms and quality of life.
“Other recent psychosocial interventions have been, in contrast, ineffective for both carer psychological symptoms and quality of life”
From Clinical effectiveness of a manual based coping strategy programme (START, STrAtegies for RelaTives) in promoting the mental health of carers of family members with dementia: pragmatic randomised controlled trial (2013) · cites this paper as [37]
The Methods (Study outcomes) identify caregiver depressive symptoms and health-related quality of life as primary outcomes, and the Discussion (Conclusions) reports no significant benefit over structured support at 12 months. But the claim generalises this result to other recent psychosocial interventions; the Discussion (Comparisons with other studies) also reports a small significant overall benefit for caregiver depressive symptoms in a review. (LLM, conf=0.85)
Experimental — accuracy not yet measured
DAISY did not improve the patient's QoL.
“Like our study, it did not improve the patient's QoL.”
From START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manual-based coping strategy programme in promoting the mental health of carers of people with dementia (2014) · cites this paper as [61]
Recent RCTs of psychosocial interventions in Europe using different models have been ineffective in terms of carer psychological symptoms and QoL.
“Recent RCTs of psychosocial interventions in Europe (UK, Denmark and Norway) using different models have been ineffective in terms of carer psychological symptoms and QoL”
From START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manual-based coping strategy programme in promoting the mental health of carers of people with dementia (2014) · cites this paper as [61]
DAISY did not help the carer's QoL.
“Unlike ours, it did not help the carer's QoL.”
From START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manual-based coping strategy programme in promoting the mental health of carers of people with dementia (2014) · cites this paper as [61]
72% of participants in DAISY completed the intervention according to the study's definition.
“In contrast to the former study, 72% of participants completed the intervention according to the study's definition (attending three or more of individual and educational sessions).”
From START (STrAtegies for RelaTives) study: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manual-based coping strategy programme in promoting the mental health of carers of people with dementia (2014) · cites this paper as [61]

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Self-citation
The DAISY psychosocial intervention does not improve outcomes in patients with mild Alzheimer's disease or their carers
Mittelman, M. S. (2012) · Evidence-Based Mental Health · doi:10.1136/eb-2012-101014 · Cited by 2 · see citing works

Authors: Waldorff, F. B., Buss, D. V., Eckermann, A., Rasmussen, M. L. H., Keiding, N., Rishoj, S., Siersma, V., Sorensen, J., Sorensen, L. V., Vogel, A., & Waldemar, G.
Affiliations: University of Copenhagen (DK)
Copenhagen University Hospital (DK)
Corresponding author: Waldorff, F. B.
ORCID: Waldorff, F. B.
Keiding, N.
Siersma, V.
Vogel, A.
Waldemar, G.
Venue: BMJ
Publisher: BMJ
Published: 2012-07-17
Volume: 345
Issue: jul17 1
Pages: e4693-e4693
ISSN: 1756-1833 (ISSN-L)
DOI: 10.1136/bmj.e4693
PMC: PMC3398860
OpenAlex: W1983171150
Cited by: 106
References: 53
Citations by year: 2026: 5 · 2025: 4 · 2023: 4 · 2022: 8 · 2021: 6 · 2020: 9 · 2019: 12 · 2018: 7 · 2017: 5 · 2016: 9 · 2015: 11 · 2014: 15 · 2013: 9 · 2012: 2
FWCI: 8.32
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc
Locations: BMJ (publishedVersion, cc-by-nc)
PubMed Central (publishedVersion, cc-by-nc)
PubMed (publishedVersion)
Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion)
Funders: Ministeriet Sundhed Forebyggelse
Hvidovre Hospital
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
Health Sciences › Health Professions › Pharmacy › Nursing care and research
Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
Keywords: Alzheimer's disease, mild dementia, psychosocial interventions, caregiver support, patient counseling, depression, quality of life, cognitive decline, memory clinics
MeSH terms: Aged, Aged, 80 and over, Alzheimer Disease, Counseling, Denmark, Female, Humans, Male, Middle Aged, Patient Education as Topic, Psychiatric Status Rating Scales, Quality of Life, Social Support, Single-Blind Method, Caregivers, Outcome Assessment, Health Care

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Efficacy of psychosocial intervention in patients with mild Alzheimer’s disease: the multicentre, rater blinded, randomised Danish Alzheimer Intervention Study (DAISY)

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