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

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). ConclusionsThe 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. IntroductionAlzheimer's disease is a common neurodegenerative disease characterised by progressive decline in cognitive, social, and occupational function, and often associated with affective symptoms and behavioural disturbances. 1 Alzheimer's disease accounts for 60-80% of all cases of dementia, and recent figures indicate that as many as 35 million people worldwide have dementia, which is projected to increase to 65 million within the next two decades. 2 Most patients with Alzheimer's disease reside in the community and require assistance and supervision from care givers. BeingCorrespondence to: F B Waldorff fransw@sund.ku.dk Extra material supplied by the author. Effect of the intervention compared with control (intention-to-treat analysis) on the primary and secondary outcomes and the difference of these outcomes from baseline, with outcomes reported as medians with interquartile ranges (see http://www.bmj.com/content/345/bmj.e469...

Raising the standard of applied dementia care research: addressing the implementation error

“…However, many studies fail to report positive outcomes (Olazaran et al, 2010). For example, recent pragmatic trials of support programmes (Kurz et al, 2012;Low et al, 2013;Van de Ven et al, 2013;Waldorff et al, 2012), telecare (Bardsley, Steventon, & Doll, 2013), training interventions (Beer et al, 2011;Spijker et al, 2011) and system enhancements or novel methods of delivering services (Goldberg et al, 2013;Meeuwsen et al, 2012;Nourhashemi et al, 2010;Van Houdt & De Lepeleire, 2010) all report no positive effects compared with the control 'usual care' condition. One study nonetheless demonstrated improvements in the patient experience and family carer satisfaction (Goldberg et al, 2013) whilst others point to problems with delivery of the intervention by practitioners such as poor adherence and variation in practice (Low et al, 2013;Spijker et al, 2013;Wenborn et al, 2013).…”

Cost Analysis of Early Psychosocial Intervention in Alzheimer's Disease

“…In the present case, a 1-year follow-up on the effect of the intervention reported no overall difference between groups [10]. However, in a qualitative study, patients and caregivers indicated that they found the intervention stimulating and rewarding and that it helped them to find new ways to cope with the challenges of the disease [33].…”

“…The fields of geriatrics, psychiatry, neurology, psychology, care science, family medicine, and law were involved in the development of a psychosocial supportive intervention to be tested in a randomised controlled trial [9]. Clinical evaluation after 1 year of follow-up demonstrated no effect on most of the applied outcome measures [10]. However, further analysis in a social decision-making context is warranted.…”

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

“…15 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, thus showing that our findings were not explained solely by the offer of a therapist to spend time and attention. 24,61,62 The earliest study of the three used trained ex-carers in a voluntary sector befriending intervention and was not taken up by many carers. 24 This suggests that acceptability, as well as the theoretical background, needs to be a major focus of any intervention.…”

“…Danish Alzheimer's Intervention Study (DAISY) was a multifaceted intervention involving both the person with mild Alzheimer's disease and the carer. 61 The intervention was individualised to the dyad, who were seen both individually and together by a nurse for counselling, based on validating the participants and focusing on retained and positive attributes and skills. It allowed patient and carer to tell their own life story and explain what mattered to them.…”