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Neurology
Research
A three-year follow-up on the efficacy of psychosocial interventions for patients with mild dementia and their caregivers: the multicentre, rater-blinded, randomised Danish Alzheimer Intervention Study (DAISY)
  1. Kieu T T Phung1,
  2. F B Waldorff1,2,
  3. D V Buss1,
  4. A Eckermann1,
  5. N Keiding3,
  6. S Rishøj1,
  7. V Siersma2,
  8. J Sørensen4,
  9. R Søgaard4,
  10. L V Sørensen1,
  11. A Vogel1,
  12. G Waldemar1
  1. 1Memory Disorders Research Group, Danish Dementia Research Centre, Department of Neurology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark
  2. 2Research Unit and Department of General Practice, Institute of Public Health, University of Copenhagen, Copenhagen, Denmark
  3. 3Department of Biostatistics, Institute of Public Health, University of Copenhagen, Copenhagen, Denmark
  4. 4Centre for Applied Health Services Research (CAST), University of Southern Denmark, Odense, Denmark
  1. Correspondence to Dr Kieu T T Phung; thien.phung{at}mail.mcgill.ca

Abstract

Objectives To examine the long-term efficacy at the 36-month follow-up of an early psychosocial counselling and support programme lasting 8–12 months for community-dwelling patients with mild Alzheimer's disease and their caregivers.

Design Multicentre, randomised, controlled, rater-blinded trial.

Setting Primary care and memory clinics in five Danish districts.

Participants 330 home-dwelling patients with mild Alzheimer's disease and their primary caregivers (dyads).

Interventions Dyads were randomised to receive intervention during the first year after diagnosis. Both intervention and control groups had follow-up visits at 3, 6, 12 and 36 months.

Main outcome measures Primary outcomes for the patients assessed at 36-month follow-up were changes from baseline in global cognitive function (Mini-Mental State Examination), depressive symptoms (Cornell Depression Scale) and proxy-rated EuroQoL quality of life on visual analogue scale. The primary outcomes for the caregivers were changes from baseline in depressive symptoms (Geriatric Depression Scale) and self-rated EuroQoL quality of life on a visual analogue scale. The secondary outcome measures for the patient were proxy-rated Quality of Life Scale for Alzheimer's disease (QoL-AD), Neuropsychiatric Inventory-Questionnaire, Alzheimer's disease Cooperative Study Activities of Daily Living Scale, all-cause mortality and nursing home placement.

Results At a 36-month follow-up, 2 years after the completion of the Danish Alzheimer Intervention Study (DAISY), the unadjusted positive effects previously detected at the 12-month follow-up in one patient primary outcome (Cornell depression score) and one patient secondary outcome (proxy-rated QoL-AD) disappeared (Cornell depression score, p=0.93; proxy-rated QoL-AD, p=0.81). No long-term effect of DAISY intervention on any other primary and secondary outcomes was found at the 36-month follow-up.

Conclusions For patients with very mild Alzheimer's disease and their caregivers, an intensive, multi-component, semitailored psychosocial intervention programme with counselling, education and support during the first year after diagnosis did not show any positive long-term effect on primary and secondary outcomes.

Trial registration The study was registered in the Clinical Trial Database (http://www.controlled-trials.com/ISRCTN74848736).

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

https://doi.org/10.1136/bmjopen-2013-003584

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