The MOMANT study, a caregiver support programme with activities at home for people with dementia: a study protocol of a randomised controlled trial.

BACKGROUND: Because of the expected increase in the number of people with dementia, and the associated social and economic costs, there is an urgent need to develop effective and cost-effective care for people with dementia and their caregivers. The intervention proposed here combines two approaches to caregiver support that have shown to be effective in empowering caregivers, i.e., multiple components for caregiver support and actively engaging caregivers to involve the person with dementia in activities at home. The aim is to investigate whether the intervention is effective in improving quality of life in the caregiver and the person with dementia. A further aim will be to investigate whether this intervention can improve caregivers' feeling of competence, experience of caregiving, and mood. METHODS: The study design is a pragmatic, cluster randomised controlled trial with cost-effectiveness analysis. The study participants are informal caregivers and home-living persons with dementia for whom they care, recruited in various regions in the Netherlands. The trial will compare outcomes in two groups of participants: 85 dyads who receive the intervention, and 85 dyads who receive care as usual. The intervention is a caregiver support training that is manual based and consists of 6 group sessions over 2 months. Training takes place in small groups of caregivers led by a health care professional presented at dementia day care centres. Randomisation occurs at the level of the day care centre. Participants are assessed on the outcome measures at baseline, prior to the intervention, and at 3 and 6 months after baseline. DISCUSSION: The study will provide insight into effectiveness and cost-effectiveness of an intervention that has not previously been evaluated or implemented in the Netherlands. The intervention potentially adds to the effective support options for informal caregivers of people with dementia without greatly increasing the workload for health- or social care professionals. TRIAL REGISTRATION: The trial is registered at the Dutch Trial Register at NTR6643 ; August 22nd, 2017.

The influence of the inactivating agent on the antigen content of inactivated Newcastle disease vaccines assessed by the in vitro potency test.

An in vitro potency test has recently been included in the European Pharmacopoeia (EP) monograph (01/2007:0870) to assess the potency of inactivated Newcastle disease (ND) vaccines. This enzyme linked immunosorbent assay (ELISA) is an attractive alternative for the existing in vivo potency tests especially with regard to the objective of the European Authorities to Replace, Reduce and Refine the use of laboratory animals for production and quality control of immunobiologicals. In the present study the influence of the inactivant on the antigen content established by ELISA was evaluated. Therefore, oil based vaccines containing similar concentrations of beta-propiolactone (BPL) or formaldehyde inactivated Newcastle disease virus (NDV) were examined by ELISA and in the in vivo potency tests outlined in the EP. The results obtained demonstrate that the use of formaldehyde as inactivant lowered the in vitro potency compared to BPL as inactivant. In contrast, the in vivo potency was not affected. Therefore, the ELISA should not be used to compare the potency of commercial ND vaccines containing formaldehyde inactivated NDV with those containing BPL inactivated NDV. However, the ELISA is considered an attractive alternative for the existing in vivo potency tests since it can be used by vaccine manufacturers for the release of inactivated ND vaccines.