Dataset Information

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).

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).

SUBMITTER: Phung KT

PROVIDER: S-EPMC3840334 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Publications

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).

Phung Kieu T T KT Waldorff F B FB Buss D V DV Eckermann A A Keiding N N Rishøj S S Siersma V V Sørensen J J Søgaard R R Sørensen L V LV Vogel A A Waldemar G G

BMJ open 20131121 11

<h4>Objectives</h4>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.<h4>Design</h4>Multicentre, randomised, controlled, rater-blinded trial.<h4>Setting</h4>Primary care and memory clinics in five Danish districts.<h4>Participants</h4>330 home-dwelling patients with mild Alzheimer's disease and their primary caregivers (dyads) ...[more]

PMID: 24270834

Similar Datasets

Project description:ObjectiveTo 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.DesignMulticentre, randomised, controlled, rater blinded trial.SettingPrimary care and memory clinics in five Danish districts.Participants330 outpatients with mild Alzheimer's disease and their 330 primary care givers.InterventionsParticipating 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 measuresPrimary 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.ResultsBecause 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 registrationISRCTN74848736.

Project description:ObjectiveTo assess the cost utility of early psychosocial intervention for patients with Alzheimer's disease and their primary caregivers.DesignCost utility evaluation alongside a multicentre, randomised controlled trial with 3 years of follow-up.SettingPrimary care and memory clinics in five Danish districts.Participants330 community-dwelling patients and their primary caregivers.InterventionPsychosocial counselling and support lasting 8-12 months after diagnosis and follow-up at 3, 6, 12 and 36 months in the intervention group or follow-up only in the control group.Main outcome measuresThe primary outcome measure was the cost of additional quality-adjusted life years (QALYs). Costs were measured from a societal perspective, including the costs of healthcare, social care, informal care and production loss. QALYs were estimated separately for the patient and the caregiver before aggregation for the main analysis.ResultsNone of the observed cost and QALY measures were significantly different between the intervention and control groups, although a tendency was noted for psychosocial care leading to cost increases with informal care that was not outweighed by the tendency for cost savings with formal care. The probability of psychosocial intervention being cost-effective did not exceed 36% for any threshold value. The alternative scenario analysis showed that the probability of cost-effectiveness increased over the range of threshold values used if the cost perspective was restricted to formal healthcare.ConclusionsA multifaceted, psychosocial intervention programme was found unlikely to be cost-effective from a societal perspective. The recommendation for practice in settings that are similar to the Danish setting is to provide follow-up with referral to available local support programmes when needed, and to restrict large multifaceted intervention programmes to patients and caregivers with special needs until further evidence for cost-effectiveness emerges.Trial registrationThe study was registered in the Clinical Trial Database as ISRCTN74848736.

Project description:BackgroundMost of patients with dementia are cared for by family members. Caring for people with dementia is challenging; approximately 30-55% of caregivers suffered from anxiety or depressive symptoms. A range of studies have shown that psychosocial interventions are effective and can improve caregivers' quality of life, reduce their care burden, and ease their anxiety or depressive symptoms. However, information on the acceptability of these interventions, despite being crucial, is under-reported.MethodsSystematic searches of databases were conducted for literature published on EMBASE, PubMed, The Cochrane Library, Web of Science, and PsycARTICLES until August 2017 and the searches were updated on June 2018. The selection criteria included primary studies with data about the acceptability of psychosocial interventions for informal caregivers and publications written in English. Two authors independently selected studies, extracted study characteristics and data, assessed the methodological quality of the included studies by using the Effective Public Health Practice Project (EPHPP) Quality Assessment Tool and Critical Appraisal Skills Programme (CASP) Qualitative Research Checklist, and conducted a narrative synthesis of quantitative and qualitative data.ResultsA total of 10,610 abstracts were identified through systematic searches. Based on screening titles and abstracts, 207 papers were identified that met the criteria for full paper review, with 42 papers from 13 different countries meeting the inclusion criteria. We found high- and moderate-quality evidence showing psychosocial interventions were acceptable, with important benefits for caregivers. Facilitators of acceptability included caregivers' need for intervention, appropriate content and organization of the intervention, and knowledge and professionalism of the staff. Barriers to acceptability included participants' poor health status and low education levels, caregiving burden, change of intervention implementers, and poor system performance of interventions.ConclusionThere is preliminary evidence to support the acceptability of psychosocial interventions for dementia caregivers. However, the available supporting evidence is limited, and there is currently no adequate information from these studies indicating that the acceptability has received enough attention from researchers. More well-designed studies assessing psychosocial interventions are needed to give specific statements about acceptability, and the measure of acceptability with psychosocial interventions should be more comprehensive.

Project description:IntroductionA novel coronavirus, designated SARS-CoV-2, caused an international outbreak of a respiratory illness, termed COVID-19 in December 2019. There is a lack of specific therapeutic agents based on evidence for this novel coronavirus infection; however, several medications have been evaluated as a potential therapy. Therapy is required to treat symptomatic patients and decrease the virus carriage duration to limit the communitytransmission.Methods and analysisWe hypothesise that patients with mild COVID-19 treated with favipiravir will have a shorter duration of time to virus clearance than the control group. The primary outcome is to evaluate the effect of favipiravir on the timing of the PCR test conversion from positive to negative within 15 days after starting the medicine.Adults (>18 years, men or nonpregnant women, diagnosed with mild COVID-19 within 5 days of disease onset) are being recruited by physicians participating from the Ministry of National Guard Health Affairs and the Ministry of Health ethics committee approved primary healthcare centres. This double-blind, randomised trial comprises three significant parts: screening, treatment and a follow-up period. The treating physician and patients are blinded. Eligible participants are randomised in a 1:1 ratio to either the therapy group (favipiravir) or a control group (placebo) with 1800 mg by mouth two times per day for the first day, followed by 800 mg two times per day for 4-7 days. Serial nasopharyngeal/oropharyngeal swab samples are obtained on day 1 (5 days before therapy). On day5±1 day, 10±1 day, 15±2 days, extra nasopharyngeal/oropharyngeal PCR COVID-19 samples are requested.The primary analysis population for evaluating both the efficacy and safety outcomes will be a modified intention to treat population. Anticipating a 10% dropout rate, we expect to recruit 288 subjects per arm. The results assume that the hazard ratio is constant throughout the study and that the Cox proportional hazard regression is used to analyse the data.Ethics and disseminationThe study was approved by the King Abdullah International Medical Research Centre Institutional Review Board (28 April 2020) and the Ministry of Health Institutional Review Board (1 July 2020). Protocol details and any amendments will be reported to https://clinicaltrials.gov/ct2/show/NCT04464408. The results will be published in peer-reviewed journals.Trial registration numberNational Clinical Trial Registry (NCT04464408).

Dataset Information

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).

Objectives

Design

Setting

Participants

Interventions

Main outcome measures

Results

Conclusions

Trial registration

Publications

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).

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