Scolaris Content Display Scolaris Content Display

Cochrane Database of Systematic Reviews Protocol - Intervention

Environmental and behavioural modifications for improving food and fluid intake in people with dementia

This is not the most recent version

Collapse all Expand all

Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

Primary

To assess the effects of environmental or behavioural modifications on food and fluid intake and nutritional status in people with dementia.

Secondary

To assess the effects of environmental or behavioural modifications in connection with nutrition on mealtime behaviour, cognitive and functional outcomes and quality of life, in specific settings (i.e. home care, residential care and nursing home care) for different stages of dementia.

To assess the adverse consequences or effects of the included interventions.

Background

Description of the condition

The world population is ageing (United Nations 2013). Age is the strongest risk factor for dementia, therefore the number of people living with dementia is increasing (WHO 2012). Today, more than 35 million people live with dementia and the World Health Organization reports that 7.7 million more cases are identified each year (Sosa‐Ortiz 2012; WHO 2012; Prince 2013). It is estimated that this number will nearly double within the next 20 years (ADI 2009), resulting in high costs (USD 604 billion in 2010; ADI 2010), and a considerable burden to individuals and society. Moreover, patients are also now expected to live longer after first being diagnosed with dementia due to improvements in treatment and care (Wimo 2013). Recent research supports these predictions, as well as the increase in prevalence (Prince 2013); however this is mostly due to ageing. Other risk factors for dementia are declining, which could also in turn lead to a decrease in prevalence (Larson 2013).

The term 'dementia' refers to a syndrome occurring in a group of diseases that are typically of a chronic or progressive nature. It involves disturbance of multiple higher cortical functions, such as memory, thinking, orientation, perception and behaviour, and it affects the ability to perform everyday activities. Deterioration in emotional control, social behaviour or motivation often precedes or accompanies cognitive decline. The most common form of dementia is Alzheimer's disease, which is involved in 60% to 70% of cases. Vascular dementia is also very common. Lewy body dementia and frontotemporal dementia are less frequent forms. However, mixed forms are common and subtypes are indistinct (ADI 2009).

In addition to higher age and genetic factors, there are other modifiable risk factors for dementia, which involve vascular disease and its contributing factors (WHO 2012). Diabetes (Lu 2009), midlife hypertension (Qiu 2005), obesity (Beydoun 2008), midlife hypercholesterolaemia (Anstey 2008), smoking (Lee 2013), stroke (Savva 2010) and physical inactivity (Hamer 2009) have been meta‐analytically associated with an increased risk of dementia in general and a higher incidence of Alzheimer's disease.

The effects of malnutrition and the so‐called 'anorexia of aging' have already been recognised as a problem of the elderly in general (Morley 1997; Di Francesco 2007), however these effects become more severe for those living with dementia. Weight loss and malnutrition are a common problem for people with dementia (ADI 2013) and malnutrition presents from the early (Olde Rikkert 2014) to late stages of dementia (Pivi 2012). The onset of Alzheimer's disease is often preceded by several years by weight loss (Barrett‐Connor 1996; Johnson 2006). With the progression of the condition, people with dementia can develop several symptoms that influence food and fluid intake, with several possible mechanisms. While damage to the brain tissue associated with appetite control can cause anorexia (Grundman 1996), other cognitive impairments can lead to forgetting of meals, impair the ability to make food choices or lead to an inability to communicate hunger and ask for food (Gillette‐Guyonnet 2000). Psychologically, behavioural syndromes associated with physiological disturbance, such as apathy and depression, are common and associated with a decreased interest in food, but they can also cause agitation, aggressive behaviour or wandering, which can both have a negative impact on participation in mealtimes and increase energy expenditure. The senses are also affected, i.e. diminishing senses of smell and taste can reduce appetite (ADI 2013). In severe dementia, patients can develop feeding problems and become dependent on feeding assistance. In addition to problems with motor skills, swallowing problems and an inability to use utensils for self feeding, feeding problems can also include the patient refusing to eat, turning their head away while being fed, refusing to open their mouth, spitting out food, leaving the mouth open and allowing food to drop out, or refusing to swallow (Miller 1971; Watson 1993; Pivi 2012). All of these factors contribute to the high risk of people with dementia becoming malnourished, which not only increases rates of complications, hospitalisation, morbidity and mortality, but also decreases their ability to conduct activities of daily life and thus, ultimately, quality of life (Vetta 1999; Rasheed 2013). These problems present regardless of the setting, i.e. community‐dwelling people with dementia as well as those in institutionalised care can suffer from malnutrition (Roque 2013; Tamura 2013).

Description of the intervention

There are numerous interventions available that are designed to modify the mealtime environment of people with dementia, to modify the mealtime behaviour of people with dementia or their caregivers, or to integrate aspects of both with the intention of improving food and fluid intake and, subsequently, nutritional status. Fixed criteria cannot be provided and many interventions are expected to be complex, therefore we will provide the possible components of interventions. We will use the categories described by Abbott 2013 and Whear 2014 for this. This is by no means conclusive and interventions might not be easy to categorise.

  • Environmental modifications

    • Change of routine

    • Change of context

    • Change of ambience

    • Others

  • Behavioural modifications

    • Education or training of people with dementia

    • Education or training of caregivers

    • Others

Environmental modifications cover all changes to the physical surroundings, social context and timing of meals. Environmental modifications of the routine of mealtimes could either involve changing how the food is served or changing the times at which and for how long meals take place. Modifications to the context of mealtimes are aimed at which persons are present. This includes all persons present during mealtimes, such as other people with dementia, other residents in nursing facilities, family members and formal or informal caregivers. Modifications to the ambience of mealtimes are concerned with properties of the light, sound, smell or temperature of the immediate or possibly intermediate dining environment. Other examples of environmental modifications could include providing a home‐like environment by means of furniture and decoration or having tableware in high‐contrast colours. Another modification could be to provide complementary food items that the patients can resort to if they so desire, either during or in between mealtimes.

Behavioural modifications cover all changes to knowledge, skill, attitude or habits pertaining to the nutrition of either the person with dementia or those in their immediate vicinity during mealtimes. Behavioural modifications to educate and train people with dementia relate to the knowledge people with dementia have about nutrition, their skills in self feeding and their attitude and habits concerning mealtimes. Modifications to educate and train caregivers, on the other hand, are aimed at those providing assistance to people with dementia during mealtimes, but have similar objectives. Modifications that are not directly aimed at nutrition and mealtimes, but instead at, for example, oral hygiene, general motor skills or general knowledge of the condition, would not be included.

Most of these interventions are likely to be modified, depending on the setting. Environmental modifications are especially expected to differ for community care as opposed to institutionalised care. We expect to encounter complex interventions and will provide more information in the 'Characteristics of included studies' table. This will include a description of which materials or procedures were used, who provided them, how these were delivered and the setting, as well as when and how often the interventions were delivered. We will also provide information on comparator interventions if applicable. These descriptions will at least be oriented towards formal measures to describe complex interventions or adopt a suitable instrument, e.g. TIDieR (Hoffmann 2014) or CReDECI (Möhler 2012).

How the intervention might work

Environmental modifications that change the routine, as well as those that change the context, mostly address the important role of the internalised expectations, preferences and habits of the individual when experiencing mealtimes (Sidenvall 1994; Sidenvall 1999; Fjellström 2008; Aselage 2010; Fjellström 2010; Strathmann 2013). Meals are usually highly standardised and process‐oriented, especially in nursing care facilities. One extreme would be reheated food served in trays at set times every day in a large group of other patients. Individual preferences on how and when food is served can rarely be addressed and mealtimes happen in relative anonymity, even though the aspects just described are important considerations for elderly people (Leslie 2011). Interventions that change these processes, for example by employing more family‐style mealtimes, by serving bulk food in a smaller group, are possibly more likely to cater to the habits, eating patterns and actual hunger of these individuals (Barnes 2013). Presented with this form of liberalisation and a more engaging social context, the overall quality of mealtimes for people with dementia might increase and with greater pleasure derived from this event, they are more likely to increase their food intake as they can choose their preferred food, serving size and time spent eating (Lorefalt 2012). Nonetheless, some form of help during mealtimes is often necessary and providing caregivers, or in the case of institutionalised care improving the ratio of people with dementia to nurses, can prove beneficial (Kayser‐Jones 1997; Marshall 2013), and can be considered an environmental modification. Who is present during mealtimes is an important aspect of context, be it other people with dementia, other residents of nursing facilities, family members and formal or informal caregivers. It is, however, a difficult balance to meet the personal preferences of the persons concerned and also the necessities of support. Environmental modifications that change ambience often address the importance of sensory stimuli for the activity levels and mood of the individual. In institutional care, people with dementia often experience insufficient sensory stimulation and might become prone to apathy, depression or generally decreased activity levels, which might negatively affect participation during mealtimes. An increase in lighting, bright colours or stimulating music might therefore increase activity levels (Forbes 2014). Music can either have the effect of raising levels of activity or a soothing effect when people with dementia are agitated (Vink 2003).

Behavioural modifications to educate and train people with dementia are often designed to improve their capabilities in self feeding. With progressive cognitive decline basic motor skills and hand‐eye co‐ordination suffer. By training people in these skills, they might be maintained for a longer period of time through the progression of dementia or formerly lost skills might possibly be regained. Although the degeneration of brain tissue is irreversible, training in specific skills and thus strengthening their neural representation might delay their loss. Higher dependency in activities of daily living is strongly associated with lower quality of life (Beerens 2013), which in turn affects symptoms like agitation or depression. In general, increased activities outside of mealtimes can decrease agitation (Livingston 2014), which in turn can improve mealtime behaviour. Furthermore, training can aim to support patients in their ability to recognise the context of mealtimes and act accordingly (Cleary 2012). While forgetfulness may lead to skipping of meals, impaired decision‐making, slow food choice and reduced intake, training regarding mealtime schedules or a choice of menus can help to preserve healthy mealtime habits. Behavioural modifications to educate or train caregivers of people with dementia could address their feeding skills or their interaction with their charges during mealtimes. Depending on the severity of symptoms and mealtime difficulties, some sort of assistance becomes necessary in any case, so interventions are not a matter of whether or not assistance is provided, but whether these caregivers are in some way trained to cater for people with dementia who have the aforementioned problems (Simmons 2004). This could be as simple as ensuring that the same caregiver is present during all or most mealtimes of a given patient, which accommodates the social factor of mealtimes. In most societies, eating is a social activity and people with dementia are often excluded from this. This is further emphasised when social contacts change during each mealtime, which is often the case in nursing facilities. Individualised feeding assistance can provide a better social experience during mealtimes and thus increase its overall quality, length, enjoyment and also food intake. Other skills consider how touch, guidance and redirection, or simple verbal cues and even simple scripted conversation can result in greater satisfaction, resulting in more time spent on mealtimes and fewer complications (Amella 2004; Woods 2005).

We will briefly refer to the theoretical considerations of the interventions employed in the studies eligible for this review. We will adopt a suitable instrument for describing complex interventions or parts thereof.

Why it is important to do this review

We chose environmental and behavioural nutritional interventions for this review as they are two obvious possibilities for non‐pharmacological intervention available for home care and institutionalised people with dementia. These aspects of care are often difficult or lacking and there is a growing interest in improving the quality of life, activities of daily living, well‐being and health of people with dementia. We believe that it is important to systematically review the evidence on the efficacy of environmental and behavioural interventions that aim to increase the food and fluid intake of people with dementia, because this could not only decrease the risks associated with malnutrition, but also increase overall quality of life. Interventions that modify food items, diets and recipes will be considered in a separate review.

Several reviews have been conducted to investigate the existing literature on different interventions to support nutritional status or intake (Watson 2006; Pivi 2012; Abbott 2013; Liu 2014; Whear 2014). Most of these reviews are quite recent but either have a different methodological approach or a different focus on setting or study participants. This review will apply the strict Cochrane methodology. Even if no substantial differences in findings are found, a Cochrane review will provide informative and regularly updated evidence for health care providers, formal caregivers and informal caregivers on which to base decisions. For those within community care, as well as in institutional settings, who have recognised the need for interventions to decrease the decline or possibly improve the nutritional status of people with dementia, a thorough investigation of the efficacy of the possible interventions is necessary. Based on the findings, they could then opt to employ one or more of the interventions covered. If no evidence for a positive effect can be found, efforts could instead be directed at more promising interventions outside the scope of this review.

Objectives

Primary

To assess the effects of environmental or behavioural modifications on food and fluid intake and nutritional status in people with dementia.

Secondary

To assess the effects of environmental or behavioural modifications in connection with nutrition on mealtime behaviour, cognitive and functional outcomes and quality of life, in specific settings (i.e. home care, residential care and nursing home care) for different stages of dementia.

To assess the adverse consequences or effects of the included interventions.

Methods

Criteria for considering studies for this review

Types of studies

We will include all published and unpublished randomised controlled trials (RCTs), cluster‐randomised trials and cross‐over trials using randomisation.

Types of participants

We will include individuals diagnosed with Alzheimer's disease, vascular dementia, Lewy body dementia, Parkinson's disease dementia and frontotemporal dementia. The diagnosis of dementia should be made in accordance with accepted guidelines, namely the Diagnostic and Statistical Manual of Mental Disorders (DSM; APA 2013), the International Classification of Diseases (ICD; WHO 2010), the NINCDS‐ADRDA Alzheimer's Criteria (McKhann 1984) and the NINDS‐AIREN Criteria for the Diagnosis of Vascular Dementia (Román 1993). We will consider any stage and setting of the aforementioned types of dementia. Alzheimer's disease and vascular dementia are the most common types of dementia (WHO 2012), therefore we will also include studies which cover individuals diagnosed with dementia, even if the types of dementia are not specified. We will also include studies not exclusively investigating patients with dementia, as long as people with dementia make up at least 50% of the participants or data from patients with dementia can be analysed separately.

We will exclude other types of dementia. While the aforementioned types of dementia show a great overlap in symptoms, other types (e.g. from infections such as Creutzfeldt‐Jacob, tumours, psychological disorders, heavy metal poisoning or drug abuse) show very different progression and complications, which is why we will not include them. If it is not possible to exclude the data from patients with other types of dementia and these patients make up more than 50% of the participants, we will exclude the study. We will also exclude data from individuals receiving parenteral nutrition or being tube‐fed, because the interventions in this review are not or are only partially designed for these patients. If it is not possible to exclude the data from tube‐fed patients and this patient group makes up more than 50% of the participants, we will exclude the study.

Types of interventions

Experimental interventions

We will include studies using behavioural or environmental modifications as interventions to increase food intake in people with dementia. As we cannot compile a definitive list of interventions, we will instead provide the categorisation presented above. In the case of a study with several arms, at least one arm has to be an environmental or behavioural modification as defined above for the study to be eligible for this review.

Comparator interventions

Three kinds of comparator interventions are eligible for this review:

  • Usual care or optimised usual care

  • Any other intervention included in this review

  • Any non‐specific intervention

Exclusions

Although it is arguably part of the mealtime environment, we consider all modifications exclusively aimed at what food is actually served to be out of the scope of this review. This includes diet, texture, seasoning or composition, as well as oral nutritional supplements.

We will exclude any intervention using one of the following means:

  • Parenteral nutrition

  • Tube feeding

  • Modifying food for swallowing difficulties

  • Drugs

Types of outcome measures

We will only consider patient‐relevant outcomes. We will exclude outcomes relevant to other stakeholders (e.g. relatives or health professionals) or biomarkers.

Primary outcomes
Intake of food and liquids

  • Energy intake measured in calories or joules, food intake measured in portion sizes or composition and weight, and fluid intake measured in volume. We will accept prospectively and professionally (e.g. dietician, nurse) conducted dietary protocols. The amount of intake should be measured in portions or calories (or both), if possible taken in relation to professionally estimated nutritional requirements.

There is no broad consensus on the content and duration of dietary protocols. Systematic and measurement errors are possible due to the different methods (Kirkpatrick 2014), and the restrictions on the functional and cognitive abilities of people with dementia. To establish stable changes in mealtime behaviour and thus intake of food and liquids, studies should have a follow‐up of at least four days.

Nutritional status

  • Nutritional status and body composition measured by absolute or relative change in weight, body mass index (BMI).

  • Nutritional status and malnutrition measured with validated tools for the assessment or screening of malnutrition, such as the Mini Nutritional Assessment (MNA; Vellas 1999).

Based on common risk indicators for malnutrition (Kondrup 2003), studies investigating the maintenance or improvement of nutritional status should have a follow‐up of at least 16 weeks.

Secondary outcomes
Mealtime behaviour measured by validated tools

For example:

  • Edinburgh Feeding Evaluation in Dementia Scale (EdFED; Watson 1994).

Changes in global and specific cognitive function measured by validated tools

For example:

  • Alzheimer's Disease Assessment Scale‐Cognitive subscale (ADAS‐cog; Rosen 1984).

  • Mini‐Mental State Exam (MMSE; Folstein 1975).

The European Medicines Agency (EMA) suggests a follow‐up of at least six months to demonstrate short‐term effects on cognitive outcomes (EMA 2008). However, interventions within the scope of this review are not subject to the same extensive regulatory requirements as drugs. Therefore, following the approach of the German Institute of Quality and Efficiency in Health Care (IQWIG 2008), studies investigating cognitive outcomes should have a follow‐up of at least three months.

Changes in functional outcomes (e.g. activities of daily living (ADL)) measured by validated tools

For example:

  • Alzheimer's Disease Activities of Daily Living International Scale (ADCS‐ADL; Galasko 1997).

  • Gottfries‐Bråne‐Steen scale, ADL subscale (GBS‐ADL; Bråne 2001).

Changes in quality of life (QoL) measured by validated tools

For example:

  • Dementia quality of life questionnaire (DEMQOL or DEMQOL‐Proxy, Smith 2005).

Others

  • Global change in symptoms and performance (measured by validated global scales), compliance with intervention, entry to institutional care or any other reported patient‐relevant outcome.

  • Psychological or behavioural events, such as depression or agitation.

  • Adverse effects, such as aspiration‐related pneumonia or death.

The lists of instruments shown are not fully comprehensive and are possibly subject to change. We will investigate the instruments used in studies and provide additional information on their validity, reliability and possible issues (e.g. lack of sensitivity in connection with the question at hand) should they prove to be eligible for inclusion.

We will use the GRADE approach to assess the overall quality of evidence for each outcome (Guyatt 2011). We will prioritise the above defined outcomes before the literature search. We will include all outcomes rated as important but not more than seven outcomes in the 'Summary of findings' tables.

Search methods for identification of studies

Electronic searches

We will search ALOIS, the register of the Cochrane Dementia and Cognitive Improvement Group (CDCIG). We will use the following search terms:

behavio*, environment*, food*, meal*, *nutrition*, beverage*, *feeding*, eating, ingestion, cooking, dinner, dining, supper.

ALOIS is maintained by the Trials Search Co‐ordinator and contains dementia and cognitive improvement studies identified from:

  1. monthly searches of a number of major healthcare databases: MEDLINE, EMBASE, CINAHL, PsycINFO and Lilacs;

  2. monthly searches of a number of trial registers: metaRegister of Controlled Trials; UMIN Clinical Trials Register (Japan); the World Health Organization (WHO) portal (which covers ClinicalTrials.gov; International Standard Randomised Controlled Trial Number (ISRCTN); Chinese Clinical Trials Register; German Clinical Trials Register; Iranian Registry of Clinical Trials and the Netherlands National Trials Register, plus others);

  3. quarterly searches of the Cochrane Central Register of Controlled Trials (CENTRAL);

  4. six‐monthly searches of a number of grey literature sources: ISI Web of Knowledge Conference Proceedings; Index to Theses; Australasian Digital Theses.

To view a list of all sources searched for ALOIS see About ALOIS on the ALOIS website.

We will run additional separate searches in many of the above sources to ensure that the most up‐to‐date results are retrieved. The search strategy that we will use for the retrieval of reports of trials from MEDLINE (via the Ovid SP platform) can be seen in Appendix 1.

Searching other resources

We will review reference lists from included studies and relevant reviews. We will contact authors of landmark papers for overlooked, unpublished and ongoing trials.

Data collection and analysis

Selection of studies

We will obtain the lists of references and merge these using EndNote X5 (EndNote 2011), to check for duplicates.

Two review authors will independently examine titles and abstracts from all search results to identify eligible studies. If it is not possible to discern the eligibility of a study from the title alone or from the title and abstract alone, we will try to obtain a copy of the report to make a decision. We will resolve differences on the eligibility of studies by discussion to reach consensus and, if necessary, by involving a third author. For all full texts of studies eligible for inclusion we will also acquire all errata and supplementary data. We will translate full texts that are not in English or German, if necessary by employing a translation service.

We will link together multiple reports of the same study. Two review authors will evaluate the full texts of relevant articles independently according to the eligibility criteria. They will not be blinded to the study data. We will resolve possible disagreement by discussion and, if necessary, by involving a third author. We will list final decisions on the exclusion of articles that were retrieved in full text. We will document the selection process as suggested in the PRISMA statement (Liberati 2009).

Data extraction and management

Two authors will independently read and extract the data from each study included. If any discrepancies occur, we will involve a third review author to resolve the matter. Depending on the topic, the third review author will be a methodologist or content area expert. In case of language ambiguity, we will involve methodologists or healthcare professionals familiar with the language in question.

We will use an electronic data extraction form, including source, eligibility, methods, participants, interventions, comparators, outcomes, results and miscellaneous notes according to the Cochrane Handbook for Systematic Reviews of Interventions (Chapter 7.3; Higgins 2011). Additionally, we will assess details of funding source, declaration of interests of the primary investigators and methods used to control possible conflicts of interests. Two review authors will pre‐test the form using two studies. Thereafter, we will adapt it if necessary.

For continuous data we will extract mean differences, standard deviations (SDs) and standardised mean differences (SMD), and the number of participants used to measure the outcome for each group.

For dichotomous outcomes we will extract the numbers of outcomes and participants. If the data provided are insufficient, we will try to complete them with the help of the authors of the report (see the section Dealing with missing data). If this proves impossible, we will try to deduce the numerical data from sample sizes and the given percentages.

If only mean differences between the groups for continuous data or odds ratio or risk ratio for dichotomous data, as well as corresponding standard errors or equivalent measures of uncertainty, are reported we will extract these instead, in case the study in question is eligible for meta‐analysis, which we would then conduct using the generic inverse variance method.

One author will then enter the data into Review Manager 5 (Review Manager 2014). Another author will check the data for accuracy.

If study protocols are published, we will also extract data from ongoing studies including study name, methods, participants, interventions, outcomes, starting date, contact information and notes.

Assessment of risk of bias in included studies

Two authors will independently assess the risk of bias for each study, using The Cochrane Collaboration's tool for assessing risk of bias (Chapter 8.5; Higgins 2011). We will resolve any disagreements by discussion to reach consensus and, if necessary, by involving a third author. We will describe the risk of bias of all the included studies in tables and narratively. Additionally, we will provide an overall judgement about the included studies in the 'Risk of bias' tables and 'Risk of bias' charts.

Measures of treatment effect

We will use the mean difference or standardised mean difference with 95% confidence interval for continuous outcomes and the risk ratio with 95% confidence interval for the analysis of dichotomous outcomes. Should any relevant ordinal outcome be encountered, we will only consider this if it can justifiably be treated as a continuous variable or can be sensibly dichotomised. As there are no definite guidelines on how to handle these measurements, we will report on our decision, which we will reach in discussion with at least two authors.

Unit of analysis issues

The unit of analysis is the individual with dementia. We will account for any unit of analysis errors stemming from the study design. For cross‐over‐trials we will only use first period data. For studies with multiple treatment arms we intend to combine comparable groups. If the outcome is measured at more than one time point, we will conduct several meta‐analyses of the results from comparable time points (± one week) and we will address this in the sensitivity analysis.

Dealing with missing data

If data from a study are missing and cannot be retrieved using other statistics given, we will try to contact the trial authors to complete the data. For this, we will make at least two contact attempts over six weeks, checking for alternate contact information if the first attempt should fail. If complete data cannot be retrieved, we will report this in our assessment of bias and address missing outcomes and summary data as a source of bias in data analysis.

We intend to perform intention‐to‐treat (ITT) analysis, but recognise that this will most likely not be possible without some sort of imputation strategy to deal with missing data. Statistical analysis compensating for missing data is always based on assumptions that can rarely be verified and can thus itself be a source of bias (Unnebrink 2001). Should data not be sufficient for a proper ITT analysis, we will instead revert to an available case analysis, include the absence of ITT analysis in the study as a source of bias and consider strategies to compensate for missing data to enable ITT in the sensitivity analysis.

We will also consider addressing other issues relating to missing data in the sensitivity analysis.

Assessment of heterogeneity

We will evaluate clinical and statistical heterogeneity. For the assessment of clinical heterogeneity we will examine the data extraction tables and consider the data for between‐study variability with respect to participants, interventions, technology and outcome measurements.

We will assess heterogeneity using the Chi² test and double check this graphically by the use of forest plots. Additionally, we will quantify inconsistency using the I² statistic.

Assessment of reporting biases

We will try to minimise reporting bias by the inclusion of published and unpublished trials. If there are enough studies available (more than 10) we will use a funnel plot and Egger's test for asymmetry to detect possible reporting bias (Egger 1997). Furthermore, we will compare conference abstracts and available trial protocols for the included studies, looking for study data or authors appearing in said abstracts or protocols.

Data synthesis

We will perform all statistical analyses using Review Manager 5 (Review Manager 2014). We will perform meta‐analyses for the primary and secondary outcomes where there are sufficient data from the included studies to estimate an overall treatment effect of comparable interventions, comparators and outcomes. Therefore, we will consider all primary and secondary outcomes listed for data synthesis.

If the same outcome is measured with similar scales, we will use mean differences for continuous outcomes instead of standardised mean differences.

We will judge the appropriateness of conducting a meta‐analysis by discussion, considering the clinical and statistical heterogeneity and the number of studies. If meta‐analysis is not possible because of significant heterogeneity, we will present the results of each study in a forest plot without estimating an overall effect. In such cases we will provide a narrative account of the results. Where we perform a meta‐analysis, we will use a random‐effects model. We assume that there will be heterogeneity due to the diverse and complex interventions.

Subgroup analysis and investigation of heterogeneity

If study data are sufficient, we will conduct the following subgroup analyses:

  • Type of dementia.

  • Stage of dementia, differentiating very mild, mild, moderate and severe dementia, as defined by validated tools such as the CDR‐SB (O'Bryant 2008) or MMSE (Perneczky 2006).

  • Setting, differentiating home care as well as residential care homes and nursing care homes with or without specialised dementia care.

We will perform tests for heterogeneity using the Chi2 test and the I2 statistic within each of these groups. For each of the subgroups, if sufficient data are available, we will perform a meta‐analysis using a random‐effects model, if there is heterogeneity. If there is no statistical heterogeneity within a group, we will use a fixed‐effect model instead.

Sensitivity analysis

If necessary, we will conduct sensitivity analyses. Aside from questions arising during the review process, we intend to perform several sensitivity analyses.

Where meta‐analyses are conducted we will explore the differences between the fixed‐effect and random‐effects models. We are choosing not to impute any data in the data synthesis, therefore we will employ imputation methods in the sensitivity analysis to check for possible bias from missing data. This explores any possible bias where studies were excluded from meta‐analysis due to missing summary data or where data necessary for ITT analysis were missing.