- F B Waldorff, associate research professor12,
- D V Buss, lawyer1,
- A Eckermann, research assistant1,
- M L H Rasmussen, research assistant1,
- N Keiding, professor of biostatistics3,
- S Rishøj, registered nurse1,
- V Siersma, senior statistician2,
- J Sørensen, professor of health economy4,
- L V Sørensen, occupational therapist1,
- A Vogel, neuropsychologist1,
- G Waldemar, professor of neurology1
- 1The Memory Disorders Research Group, Department of Neurology, Rigshospitalet, Copenhagen University Hospital, 9 Blegdamsvej, 2100 Copenhagen, Denmark
- 2Research Unit and Department of General Practice, Institute of Public Health, University of Copenhagen
- 3Department of Biostatistics, Institute of Public Health, University of Copenhagen
- 4Centre for Applied Health Services Research and Technology Assessment (CAST), University of Southern Denmark, Denmark
- Correspondence to: F B Waldorff
- Accepted 27 June 2012
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.
We thank 128 volunteer raters and assistants from the 68 municipalities and five counties and the following project coordinators and physicians in the five participating centres for their help in patient recruitment, intervention, and data collection Ribe County: Esbjerg Hospital, Department of Psychiatry (Anna Marie Hansen, Johanne Christensen, Joergen Jensen). Ringkoebing County: Herning Hospital, Department of Psychiatry (Marianne Refslund, Birgitte Aagaard, Palle Lund) and Holstebro Hospital, Department of Psychiatry (Inge Lund Petersen, Finn Andersen). Roskilde County: Roskilde Hospital, Department of Geriatrics (Dorte Dyre, Lisbeth Petersen, Birgitte Froelund, Lise Korbo, Ellen Holm) and Department of Neurology (Kurt Luedorff). Vestsjaelland County: Korsoer Hospital, Department of Geriatrics (Mette Lassen, Lars Laugesen) and Dianalund Hospital, Department of Psychiatry (Thyge Jensen, Ole Bjoern Skausig). Copenhagen Capital area: Hvidovre Hospital, Department of Geriatrics (Lillian Moerk Joergensen), Amager Hospital, Department of Geriatrics (Suzanne Sanders), Bispebjerg Hospital, Department of Geriatrics (Claus Moe), Frederiksberg Community Health Care Centre (Ingrid Lauridsen), Frederiksberg Hospital, Department of Psychiatry (Rene Klysner), Glostrup Hospital, Department of Neurology, (Jens Feilberg), Rigshospitalet, Department of Neurology (Eva Illemann, Peter Johannsen). We also thank Professor Mary S Mittelman for fruitful discussions.
Contributors: FBW drafted the manuscript. FBW, VS, NK, MLHR, and GW outlined the statistical analysis. VS conducted the statistical analysis in consultation with NK. FBW, AE, DVB, and GW designed and conducted the DAISY study. All authors assisted in editing this manuscript. All authors read and approved the final manuscript.
Funding: The DAISY study was supported by the National Board of Social Services at the Danish Ministry of Social Affairs, the Danish Ministry of Health and the Danish Health Foundation. All researchers were independent from the funders, and the funders were not involved in the collection, analysis, and interpretation of data, in the writing of the report, or in the decision to submit the article for publication.
Competing interest: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: GW had support from the National Board of Social Services at the Danish Ministry of Social Affairs, the Danish Ministry of Health, and the Danish Health Foundation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: The DAISY trial was conducted in accordance with the Helsinki Declaration. According to the Danish Act on Research Ethics, approval from the regional ethical committee was not required. However, we presented the protocol to the regional ethical committee for Copenhagen and Frederiksberg municipalities. The committee reported that no approval was needed (ID No (KF) 02-005/04). The Danish Data Protection Agency approved the research database (ID No 2003-41-3178).
Data sharing: The dataset is available from the corresponding author at email@example.com.
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