HEALTH AND NUTRITIONAL PROMOTION PROGRAM FOR … · health and nutritional promotion program for...

The Journal of Nutrition, Health & Aging©Volume 13, Number 6, 2009

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Introduction

As the population ages, there is an increase in the number ofpeople with disability (1) and specially of those diagnosed withchronic neurodegenerative disorders, Alzheimer's disease (AD)and other forms of dementia (2, 3). In Europe the prevalencerates for dementia is between 6% to 10 % in subjects aged 65and over, with approximately 60% of those have AD (4-6).Median estimated survival time was 4.5 years for all peoplewith dementia of age and 10.7 years for elderly aged 65-69years (7), and 50% of dependence in the elderly is related toAD (8), which indicate the increasing need of care for elderlywith dementia

Protein-energy malnutrition (PEM) is extremely frequentamong elderly people with chronic illnesses. Screening formalnutrition show that incidence of malnutrition is low in thecommunity (2% ± 0.1 (mean ± SE); 21 studies, n = 14149elderly), while a high prevalence is present in hospitalized andinstitutionalized elderly patients (hospital: 23 ± 0.5%; 35studies, n = 8596 and institutions: 21 ± 0.5%; 32 studies, n =6821 elderly) (9). PEM has multiple causes. Among theproblems most frequently detected are: dependency on feeding,depression, dementia and associated eating behaviourproblems, polymedication, without forgetting specific

inflammatory reactions produced by some chronic illnesses.Alzheimer's disease can be considered a risk factor for sufferingPEM. In cognitively impaired elderly subjects prevalence ofmalnutrition was 15 ± 0.8% (10 studies, n = 2051 elderlysubjects), and 44 ± 1.1% of risk of malnutrition (9). Impairedcognitive function induces dependence in the activities ofeveryday life, particularly related to eating (10-12), and lownutrient intakes relate to frailty (13).

Various studies show that patients with AD have higherweight loss percentages than healthy people of the same age(14, 15) and weight loss is also present early in disease or evenpreceded dementia (16-19), suggesting weight loss aspreclinical marker of dementia (20, 21). Correlation was foundbetween the stage of dementia and weight loss so that theseverer the dementia the greater the weight loss. Involuntaryweight loss has been correlated with a worsening in the state ofhealth, elderly who had lost more than 4% of their weight in ayear had higher morbi-mortality (17, 22). Weight loss predictsfunctional decline (23) and elderly with weight loss relatedmalnutrition have a greater risk of being institutionalised (24).In AD patients besides changes in metabolic state and appetite,causes of weight loss in AD are related to the changes infeeding behaviour which entail a nutrient-poor intake (12, 25-27). Intervention with caregivers seems to be effective in the

JNHA: CLINICAL TRIALS AND AGING

HEALTH AND NUTRITIONAL PROMOTION PROGRAM FOR PATIENTS WITH DEMENTIA (NUTRIALZ STUDY): DESIGN AND BASELINE DATA

A. SALVA1, S. ANDRIEU2,3, E. FERNANDEZ1, E.J. SCHIFFRIN4, J. MOULIN5, B. DECARLI5, Y. GUIGOZ4, B. VELLAS2,6 AND THE NUTRIALZ GROUP*

1. Institut de l'Envelliment, Universitat Autónoma de Barcelona, Barcelona, Spain; 2. Inserm U558, F-31073 Toulouse, France; 3. CHU Toulouse, Service d’épidémiologie et de santépublique, F-31073 Toulouse, France; 4. Nestlé Nutrition, Nestec Ltd, CH-1800 Vevey, Switzerland; 5. Nestlé Research Center, CH-1000 Lausanne 26, Switzerland; 6. Gérontopôle,

Hôpitaux de Toulouse, F-31073 Toulouse, France. Corresponding Autor: Antoni Salvà, Institut de l'Envelliment, Universitat Autónoma de Barcelona, St. Antoni M. Claret 171, 08041Barcelona, Spain, E-mail: [email protected]

Abstract: Background: There is a lack of data on global weight loss prevention programs for patients withdementia or clear evidence about their impact on a functional level, caregiver burden or the use of healthcare andsocial resources. “NutriAlz” is a socio-educative and nutritional intervention program to prevent weight loss andloss of function in dementia patients. Study Design and Methods: A cluster randomized multi-centre study, whichwill allow the comparison of a group benefiting from the intervention with a control group after a year ofmonitoring. Patients were recruited from 11 hospitals in the ambulatory diagnostic units and day care centres.The baseline interview include: sociodemographic and socioeconomic variables (age, gender, educational level,marital status); diagnostic, treatments, MMS, a list of comorbid conditions; activities of daily living (ADL,IADL), Zarit Scale, brief-NPI, Cornell scale and nutritional status as measured by the Mini NutritionalAssessment. All participants or their family signed the inform consent form. Baseline characteristics: Total of946 patients were included, with a mean (± SD) of 79 ± 7.3 year of age; 68,1 % were women; 44,9% lives withtheir partner, only 3% lives alone; 79.8% had Alzheimer’s dementia, 5.25 ± 3.0 years since symptoms ofdementia and 2.8 ± 2.11 years since diagnosis. Mean MMSE score was 15.4 ± 6.2; mean weight was 64.4 ± 12.5kg; mean BMI was 27.0 ± 4.5 (with 3% below 19, 5% between 19-21, 10% between 21-23, and 82% above 23).Mean ADL without difficulties was 3.2± 2.1; mean IADL without difficulties was 0.7± 1.6; mean number ofsymptoms in the NPI was 4.4 ± 2.59, with severity score of 7.9 ± 5.9 and distress score of 11.3 ± 9.0; mean Zaritscale was 27.4 ± 15.5; mean MNA was 23.2 ± 3.5 with 5 % as malnourished, 32 % at risk of malnutrition, and63 % with adequate nutritional status.

Key words: Alzheimer disease, dementia, nutritional program.

Received February 11, 2009Accepted for publication February 17, 2009

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prevention of weight loss in people with AD (28). Theadministration of nutritional supplements is effective atimproving the anthropometric parameters in elderly people (29,30).

Nutritional intervention programs have been effective inprevention of weight loss in AD (29, 31, 32), and very recentlypractical guidelines were published (33). However, there arenot enough data about the use of global Nutrition programs forpatients with dementia or clear evidence about their impact on afunctional level, the quality of life or the use of healthcare andsocial resources. Consequently, NutriAlz study was planned todetermine the effectiveness of a teaching and trainingintervention of health and nutrition program directed both tophysician and main caregiver, and person affected byAlzheimer's disease or other dementias. The main objective ofthis study is to assess the effectiveness of the Nutrition Programon functional level in elderly people with dementia living athome, as well as, improve nutritional status and change clinicalpractice related to nutrition.

This report describe the study design, intervention program,recruitment, randomization and baseline characteristics thepatients entered in the NutriAlz study.

Methods

Study design and settingIt is a prospective cluster randomised multi-centre study,

which will allow the comparison of a group benefiting from theintervention with a control group after a year of monitoring.

Ten hospitals have agreed to participate in the study,representing different specialities (neurology, geriatrics andpsychiatry) in order to take into account the diversity of thepatients taken on and the practices of the different medicalspecialities. They have been chosen depending on the capacityfor recruiting patients affected by Alzheimer's disease. Fourcentres of neurology, 4 geriatric centres and 2 psychiatriccentres. Each centre was required to recruit an identicalnumbers of patients with an inclusion period of 6 months.

Randomization was done by centre to prevent contaminationdue to the intervention training of the different healthcareprofessionals, taking into account the centre speciality.

Just before starting study recruitment, one centre withdrawfrom the study and was replace by a another centre and due tolow recruiting capacity of one centre in the intervention group,an additional centre was added to the study. Both centres weretaken from the reserve list, and were of the same speciality asthe corresponding centres.

Study populationPatients were consecutively recruited at the outpatient clinics

(ambulatory diagnostic unit and day hospital care).

Inclusion criteriaThe study included patient who were diagnosed with

dementia according to DSM IV criteria and who were

considered to have mild to moderate dementia with MMSE lessthan or equal to 26. Only ambulatory community-dwellingsubjects living at home and who had an identified caregiverwere included. Informed consent for participation in the studywas given by the responsible relative and, if possible, from thepatient or legal guardian.

Exclusion criteriaNot included were patient who had an MMSE over 26, lived

in an institution at entry, and had no identified main carer, aswell as patient having naso-gastric tube feeding or in a terminalsituation, and patient participating in another nutritionalintervention study.

Determination of sample sizeThe number of patients necessary for a loss of 0.5 points on

the Activity of Daily Living (ADL) scale, which is clinicallysignificant, was estimated as followed: According to the Frenchcohort of AD patients, REAL.FR Study (8), 43.8% loose atleast 0.5 points after a one year follow-up period. To reducethis proportion to 30% with error type I of 5% and a type IIerror of 10% (power of 90%) 300 subjects should be included.Then taking into account a drop out rate of 30% after one year,at least 438 subjects per group should be followed, or 876subjects in total. The objective was then set to 100 patients percentre to reach about 1000 patients (500 per group).

Intervention program

Intervention: the NutriAlz programIn the centres of the "intervention" group, a standardised

protocol for feeding and nutrition was proposed, whichincluded:

1. A personalized presentation and hand over of a briefcasecontaining: information about Alzheimer's disease (booklet 1),about nutrition in particular (booklet 2), physical exercise(booklet 3), available aid and services, specifically about theprogram (booklet 4), schedule for collecting data such asweight and height, product samples, coupons for monitoring ina database, etc. This information was given to patients and theirrelatives with oral information on hotline access, NutritionProgram newsletter.

2. Training for families, caregivers were requested to attendat least 4 sessions of educational intervention done by adietician which were divided into the following sessions andtopics:- Session 1: Presentation of the participants, presentation of

the nutritional support program, presentation of the availableresources (hotline, etc.), information on weight loss withAlzheimer's disease, how to realise nutritional monitoring,how to weigh, how to fill in the nutritional schedule, onlifestyle habits, on a balanced diet and the food pyramid

- Session 2: Continuous information on lifestyle habits, on abalanced diet and the food pyramid, and program on creationof menus, conservation of food, cooking methods, how to

HEALTH AND NUTRITIONAL PROMOTION PROGRAM FOR PATIENTS WITH DEMENTIA (NUTRIALZ STUDY)


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increase calorific and protein intake, how to substitute foodsthat are rejected, nutritional support preparations, andnutritional supplements (what they are for, who prescribesthem, how and when to take them, where they can beobtained) further motivation for interest in physical exercise

- Session 3: Information on Eating behaviour problems (EBP),practical recommendations on how to cope with EBPs,nutrition and medication, nutrition and illnesses or chronicproblems, as well as diabetes, constipation, hypertension,and dyslipidemia.

- Session 4: General review, practical examples, problem-solving in the creation of menus.

3. Support in weight monitoring. A voluntary individualweight monitoring system was established through the postaldispatch to the Aging Institute (Autonomous University ofBarcelona) of coupons with information about the weight of theperson affected. According to weight curve evolution writtenrecommendation will be send by mail and if weight loss isidentified as susceptible to making the illness worse, they willbe asked to visit a doctor.

4. Periodic information for the families. A voluntary systemwas established (which was accessed through signing a coupon)through which the people (carers) who so desire received fromthe Program general information about nutrition, nutritionalneeds of those with Alzheimer's or other problems related withnutrition. The resulting register was of the caregivers (not thepatients) and complied with all legal requirements. Themanagement of this section was by the Aging Institute(Autonomous University of Barcelona).

5. Action protocols and standardised help decision trees forprofessionals was designed with the participation of at least oneperson of each intervention centre. Each centre was asked todesignate a senior member of the medical and/or nursing staff.The healthcare professionals in the intervention group receivedtraining and followed the program recommendations throughthese forms and action standards.

Control groupThe control group did not benefit from the intervention; the

subjects were followed by the centre according to each centre'susual practice. Subjects must not participate in any otherresearch program which entails intervention.

Data CollectionEach centre appointed a nurse and/or doctor to carry out the

evaluations, and data collection was controlled and monitoredby the study supervisor. At entrance into study, at 6 months and12 months of study following data will be recorded (see Figure1):

Socio-demographic and personal characteristics (age, sex,living accommodations, education, income, medication,hospitalisation)

Medical history, including comorbidities and Charlson Index

(34, 35) and treatment received.Anthropometry (weight, height, mid-arm and calf-

circumference)Cognitive state: Mini Mental State Examination (MMSE,

(36)) and Clinical Dementia Rating scale (CDR, (37, 38)); withCDR score of 0.5 representing questionable dementia, CDRscore of 1 mild dementia, CDR score of 2 moderate dementiaand CDR score of 3 severe dementia.

Nutritional evaluation: Mini Nutritional Assessment (MNA,(37-40)) and the Eating Behaviour Scale (EBS, (41, 42))

Behavioural problems: Neuropsychiatric Inventoryquestionnaire (NPI-Q, (43-45))

Depression: Cornell scale (46, 47)Autonomy in daily activities: Activities of Daily Living

scale (48) and Instrumental Activities of Daily Living scale(49)

Health care cost: Resource Utilisation in Dementia (RUD,(34, 35, 50)

Caregiver burden: Zarit scale (51) and information on maincaregiver (age, activity..)

Figure 1Study design: Multicentre cluster randomized study: Eleven

AD centres with follow up for one year

Multi-component intervention targeted at healthcare professional and AD patient’s families(Briefcase: Information/recommendation on nutrition and Alzheimer disease; ADL:Activities of Daily Living; IADL: Instrumental Activities of Daily Living; MNA: Mini-Nutritional Assessment; MMSE: Mini-Mental State Examination; Zarit: Zarit scale(caregiver burden); RUD: Resource Utilization in Dementia; EBS: Eating BehaviorScale;). Time 0 (T0): date of screening; Time 1 (T1): T0 + 2-4 weeks.



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Outcome measures

Main outcome measuresThe main evaluation criteria which will allow the

effectiveness of this intervention to be evaluated are thereduction in the loss of autonomy measured by the ADL/IADLscales.

Secondary outcome measuresThe secondary objectives of this study are:Improvement in the patient's state of nutrition: The

measurement criteria which will allow the patient's nutritionalstate to be evaluated will be their weight, BMI and MNA

Reducing the burden on caregiver: The Zarit scale will beused for this evaluation.

Evaluation of the use of healthcare and social resources: TheRUD scale will be used.

Improvement of medical practice regarding nutrition: % ofdoctors who use instruments such as the MNA, weight curve,anthropometric or biological markers before and after theprogram, % of doctors who prescribe a treatment or action ifthe MNA is less than normal, % of doctors who evaluate thenutritional state.

Statistical Methodology

Analysis setsAll subjects included in the study (with a visit T0) constitute

the global population. Intervention analysis will be done on

Intention-to-treat population (ITT) and protocol population(PP). All subjects included in the study (with a visit T0) willconstitute the ITT population and all subjects included in thestudy without major protocol deviation will constitute the PPpopulation. Primary outcome and all other tests will beconsidered significant at 5% of significance (p≤0.05).

Analysis of bivariance and mixed models, adjusted forconfounding factors, and randomisation by centre will be takeninto account in the comparison of the intervention group andthe control group (52;53).

For quantitative outcome variables: mixed covarianceanalysis (parametric) or, if the assumptions (normality andhomogeneity of the variances) are not met, mixed covarianceanalysis performed on rank data (non-parametric), will be usedwith centre as random factor. Other covariates (fixed factors)will be defined in the appropriate section.

For binary outcome variables: Mixed logistic model withcentre as random factor will be used. Other covariates (fixedfactors) will be defined in the appropriate section.

Statistical analyses are performed with SAS® V8 andAdClin® 3.2.

Results

Baseline Characteristics

Population studied and Socio-economic informationThe study population was composed of 946 community-

dwelling AD patients recruited by 11 Alzheimer outpatients



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Table 1Baseline characteristics - Socio-demographic information of the randomized NutriAlz Study Patients

Characteristics All Intervention Controln = 946 n = 448 n = 498

n (%) n (%) n (%)

Age Age groups (years)

<65 40 (4.2) 14 (3.1) 26 (5.2)65-74 191 (20.2) 87 (19.4) 104 (20.9)75-79 221 (23.4) 105 (23.4) 116 (23.3)80-84 296 (31.3) 136 (30.4) 160 (32.1)85-89 145 (15.3) 79 (17.6) 66 (13.3)>=90 53 (5.6) 27 (6.0) 26 (5.2)

Mean age ± SD (years) 79.0 ± 7.3 79.4 ± 7.0 78.6 ± 7.5Gender

Male 302 (31.9) 148 (33.0) 154 (30.9)Female 644 (68.1) 300 (67.0) 344 (69.1)

Education (years in formal education)Mean ± SD 4.8 ± 4.3 4.95 ± 3.9 4.6 ± 4.55

Number of years in education0-1 279 (29.5) 113 (25.2) 166 (33.3)2-4 190 (20.1) 83 (18.5) 107 (21.5)5-10 397 (42.0) 222 (49.6) 175 (35.1)>10 80 (8.5) 30 (6.7) 50 (10.0)

Living arrangements Lives alone 30 (3.2) 20 (4.5) 10 (2.0)

Lives witha partner, as caregiver 425 (44.9) 183 (40.8) 242 (48.6)a caregiver 229 (24.2) 90 (20.1) 139 (27.9)a caregiver & other relatives or friends 228 (24.1) 150 (33.5) 78 (15.7)Other 34 (3.6) 5 (1.1) 29 (5.8)


and day care centres (figure 1 & table 1). The mean age was 79± 7 years of age (mean ± SD) with 68 % women and 32% men.Fifty percent of the AD patients had 5 years or more ofeducation. Forty five percent live with their spouse, 48% with acaregiver with or without another relative, while 3%still livealone. No significant difference was observed between theintervention and control group for the socio-demographicvariables (table 1).

Clinical characteristicsA summary of the clinical characteristics of the subjects are

presented in table 2a-f. As expected the major dementia typeswere of Alzheimer (64.3%) and vascular (12.6%) type, withoutsignificant difference between intervention and control group(table 2a). The majority of subjects had moderate to severedementia with MMSE mean score of 15.4 ± 6.2 and CDR scoreof 1.8 ± 0.8, again without difference between groups. Stagingof dementia is as followed: very mild or questionable dementia(CDR score 0.5) 9%, mild dementia (CDR score 1) 31%,moderate dementia (CDR score 2) 39.5%, and severe dementia(CDR score 3) 21%. Time since symptoms was 5.25 ± 3.0years and the time since diagnostic of 2.8 ± 2.1.

Medications are present in 93% of the subjects, with 66%concomitant medication related with dementia (Menantime12%, Donepezil 26%, Rivastigmine 16% and Galantamine 16%of the patients) (table 2b).Vitamin supplement and nutritionalcomplement were not frequently administered (only to 7% ofthe patients). Most patients had comorbid chronic problems(with a mean number of 4.4 ± 2.4) and a Charlson Comorbidityindex of 2.1 ± 1.4 (table 2b), and 37% had fallen during the lastyear, suggesting a rather frail group of patients. This isconfirmed by the ADL score of 4.0 ± 1.75 and IADL score of2.4 ± 2.2 (table 2c). Ninteen percent were independent in ADL,

but only 3% were rather independent in IADL. However 68%were independent in feeding (ADL scale) and 59% needed tohave food prepared (IADL scale). A significant difference wasobserved for ADL score between the intervention and controlgroup (p = 0.0103), with more independent subjects in thecontrol group (24% versus 14% in the intervention group)(table 2c).

Psychosocial and behavioural disturbances assessed by theNPI-Q showed high frequency of apathy (64%),irratibility/instability (50%), depression (49%),agitation/aggression (42%) and appetite disorders (40%), with aNPI-Q score of 4.4 ± 2.6, a NPI-Q severity score of 7.9 ± 5.9and a NPI-Q distress score of 11.3 ± 9.0 ( table 2d).

Social, family, caregiver burden were assessed by the Zaritscale with a mean score of 27.4 ± 15.5, and with an indicationof higher burden in the intervention (Zarit score of 30.6 ± 15.4vesrus 24.5 ± 15.0 in the control, p = 0009) (table 2e). Timesince taken care by a caregiver was 4.1 ± 3.3 years and thecaregivers were in high majority (88%) either the spouse (39%)or the children (son/daughter) (48.5%). Only 1.6% were paidcaregivers. The mean time spent supervising was 263 ± 253hours per month (~9 hours per day) and the mean time spentwith the patient was 397 ± 257 hours.

NutritionEvaluation of the risk for malnutrition using the MNA

resulted in 5% of malnourished patients, 37% at risk formalnutrition and 58% well nourished subjects. The MNA scorewas significantly different between the two group: Intervention22.3 ± 3.8 and control group 24.0 ± 3.0, p = 0007 (table 2f).This difference was marked by the higher percentage ofmalnourished patients (8% versus 3%) and of patients at risk ofmalnutrition (47% versus 29%) in the intervention group. The



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Table 2aBaseline Clinical Characteristics of the randomized NutriAlz Study Patients


n (%) n (%) n (%)

Type of dementia n (%) n (%)Alzheimer 608 (64.3) 305 (68.1) 303 (60.8)

Vascular 119 (12.6) 48 (10.7) 71 (14.3)Mixed 131 (13.8) 64 (14.3) 67 (13.5)

(vascular & Alzheimer)Other 88 (9.3) 31 (6.9) 57 (11.4)

Time since symptoms of dementia (years)mean ± SD 5.25 ± 3.0 5.1 ± 3.0 5.35 ± 3.0

Time since diagnosis (years)mean ± SD 2.8 ± 2.1 2.7 ± 2.1 2.9 ± 2.1

MMSE score (mean ± SD) 15.4 ± 6.2 14.7 ± 6.0 16.0 ± 6.25MMSE score <11 189 (20.4) 99 (22.8) 90 (18.3)

11-20 533 (57.6) 262 (60.2) 271 (55.2)20-26 204 (22.0) 74 (17.0) 130 (26.5)

CDR global score (mean ± SD) 1.8 ± 0.8 1.8 ± 0.8 1.7 ± 0.8CDR score 0.5 82 (8.7) 26 (5.8) 56 (11.2)

1 293 (31.0) 145 (32.4) 148 (29.7)2 374 (39.5) 177 (39.5) 197 (39.6)3 197 (20.8) 100 (22.3) 97 (19.5)

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Table 2bBaseline Clinical Characteristics of the randomized NutriAlz Study Patients


n (%) n (%) n (%)

Charlson Comorbidity Index 2.1 ± 1.4 2.2 ± 1.5 2.0 ± 1.3Number of comorbid problems 4.4 ± 2.4 4.6 ± 2.2 4.2 ± 2.6

ComorbiditiesHypertension 410 43.3 196 43.8 214 43.0

Arthrosis 392 41.4 192 42.9 200 40.2Cardiovascular diseases* 223 23.6 126 28.1 97 19.5Cerebrovascular disease 163 17.2 84 18.8 79 15.9

Diabetes 153 16.2 75 16.7 78 15.7Fracture/Joint prothesis 138 14.6 69 15.4 69 13.9

Number of medications 4.4 ± 2.9 4.6 ± 3.0 4.3 ± 2.8At least one medication 882 (93.2) 414 (92.4) 468 (94.0)

Concomitant medication related with dementia 621 (65.6) 279 (62.3) 342 (68.7)Memantine 114 (12.1) 48 (10.7) 66 (13.3)Donepezil 245 (25.9) 106 (23.7) 139 (27.9)

Rivastigmine 148 (15.6) 89 (19.9) 59 (11.8)Galantamine 152 (16.1) 46 (10.3) 106 (21.3)

Vitamin supplement or nutritional complement 62 (6.6) 34 (7.6) 28 (5.6)

Fallen over the last year 348 (36.8) 186 (41.5) 162 (32.5)*Cardiovascular diseases includes heart attack, heart failure and peripheral arterial disease

Table 2cBaseline Clinical Characteristics of the randomized NutriAlz Study Patients


n (%) n (%) n (%)

ADL score (mean ± SD) 4.0 ± 1.75 3.75 ± 1.8 4.2 ± 1.7Number of activities without difficulties 3.24 ± 2.1 2.9 ± 2.1 3.6 ± 2.0

No dependency 181 (19.2) 64 (14.3) 117 (23.6)1 dependency 153 (16.2) 67 (15.0) 86 (17.3)

2 dependencies 126 (13.4) 61 (13.6) 65 (13.1)≥ 3 dependencies 483 (51.2) 255 (57.1) 228 (46.0)

Independent for Bath 311 (32.9) 126 (28.1) 185 (37.1)

Dressing 413 (43.7) 178 (39.7) 235 (47.3)Toilet use 608 (64.3) 263 (58.7) 345 (69.4)

Mobilisation 700 (74.1) 310 (69.4) 390 (78.3)Continence 383 (40.5) 152 (33.9) 231 (46.4)

Feeding 646 (68.3) 259 (57.8) 387 (77.7)Lawton IADL score (mean ± SD 2.4 ± 2.2 2.2 ± 2.1 2.50± 2.3

Number of activities without difficulties 0.71 ± 1.6 0.55 ± 1.3 0.85 ± 1.80-2 dependencies 25 (2.7) 5 (1.1) 20 (4.0)≥ 6 dependencies 915 (97.3) 442 (98.9) 473 (96.0)

Table 2dBaseline Clinical Characteristics of the randomized NutriAlz Study Patients

Characteristics All Intervention Control946 n = 448 n = 498

n (%) N (%) N (%)

NPI-Q score (mean ± SD) 4.4 ± 2.6 4.7 ± 2.6 4.2 ± 2.6Delusions 282 (29.9) 155 (34.8) 127 (25.5)

Hallucinations 211 (22.3) 117 (26.2) 94 (18.9)Agitation/Aggression 397 (42.0) 202 (45.2) 195 (39.2)Depression/dysphoria 462 (48.9) 228 (51.1) 234 (47.0)

Anxiety 481 (50.9) 241 (53.9) 240 (48.2)Exaltation/euphoria 99 (10.5) 54 (12.1) 45 (9.1)Apathy/indifference 606 (64.2) 271 (60.5) 335 (67.5)

Desinhibition 205 (21.7) 83 (18.5) 122 (24.6)Irratibility/instability 475 (50.4) 239 (53.3) 236 (47.7)

Aberrant motor behaviour 293 (31.1) 129 (28.8) 164 (33.1)Sleep symptoms 285 (30.2) 158 (35.3) 127 (25.7)

Appetite disorders 381 (40.4) 223 (49.3) 158 (31.9)NPI-Q severity score

(mean ± SD) 7.9 ± 5.9 8.1 ± 5.7 7.6 ± 6.1NPI-Q distress score

(mean ± SD) 11.3 ± 9.0 11.9 ± 8.9 10.8 ± 9.1


mean weight was 64.35 ± 12.5 kg and the mean BMI was 27.0± 4.5 with 83% of the subjects with a BMI equal or over 23.Independence for finishing meals was 77% and the duration ofthe meal 30 ± 13 minutes, and the EBS score was 16.0 ± 3.65.The independence for finishing meals was higher in the controlgroup than the intervention group, 85% versus 68.5%respectively.

In general the patients showed moderate severity ofdementia with numerous comorbidity and dependence in the

IADL. A significant difference is observed at baseline betweenthe intervention group and the control group for the number ofactivities in ADL, with higher dependency for feeding, a highercaregiver burden measured with the Zarit scale, and a higherrisk for malnutrition and more feeding problems. This suggestsa more frail intervention group compared to control group evenwith cluster randomization.



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Table 2eBaseline Clinical Characteristics of the randomized NutriAlz Study Patients


n (%) n (%) n (%)

Zarit score (mean ± SD) 27.4 ± 15.5 30.6 ± 15.4 24.5 ± 15.0Time since the caregiver took care of the patient (years) 4.1 ± 3.3 4.1 ± 3.3 4.1 ± 3.3

Age of caregiver 60.1 ± 13.6 58.35 ± 13.3 61.7 ± 13.6Women caregivers 707 (74.7) 353 (78.8) 354 (71.1)

Caregiver relationship with patientsSpouse 370 (39.1) 149 (33.3) 221 (44.4)

Son or daughter 459 (48.5) 242 (54.0) 217 (43.6)Friend 12 (1.3) 8 (1.8) 4 (0.8)

Other (unpaid) 90 (9.5) 40 (8.9) 50 (10.0)Paid caregiver 15 (1.6) 9 (2.0) 6 (1.2)

During last month, time spent by caregiver supervising the patient

Hours/day 8.9 ± 8.4 10.1 ± 9.4 7.9 ± 7.35Days/month 26.0 ± 9.9 25.4 ± 10.6 26.5 ± 9.2

Hours/month 263 ± 253 297 ± 282 234 ± 220Total time dedicated to patient during the last month 397 ± 257 428 ± 265 369 ± 247(hours)Hospitalisation within last month 55 (5.8) 44 (9.8) 11 (2.2)Cornell scale score (mean ± SD) 8.25 ± 6.1 9.9 ± 6.6 7.1 ± 5.4Score ≥ 12 179 (23.6) 103 (33.8) 76 (16.8)

Table 2fBaseline Clinical Characteristics of the randomized NutriAlz Study Patients


n (%) n (%) n (%)

MNA score (mean ± SD) 23.2 ± 3.5 22.3 ± 3.8 24.0 ± 3.0MNA score <17 49 (5.2) 35 (7.8) 14 (2.8)

17-23.5 347 (36.9) 204 (45.6) 143 (29.0)≥24 544 (57.9) 208 (46.6) 336 (68.2)

Weight (kg) (mean ± SD) 64.35 ± 12.5 63.5 ± 12.5 65.1 ± 12.5BMI ((Kg/m2) (mean ± SD) 27.0 ± 4.5 26.6 ± 4.4 27.3 ± 4.6

<19 26 (2.8) 17 (3.8) (1.8)19 -20.9 49 (5.2) 23 (5.1) (5.3)21-22.9 89 (9.4) 46 (10.3) (8.7)≥ 23 777 (82.6) 362 (80.8) (84.2)> 25 624 (66.3) 287 (64.1) 337 (68.4)

Eating behaviour scaleScore (mean ± SD) 16.0 ± 3.7 15.45 ± 3.8 16.4 ± 3.5

Duration of the meal (minutes)(mean ± SD) 30 ± 12.9 30 ± 14.3 29 ± 11.4

Independent for finishing meal 729 (77.1) 307 (68.5) 422 (84.7)Fallen over the last year 348 (36.8) 186 (41.5) 162 (32.5)


Discussion

Cluster randomised trial form was chosen in order not todisturb the normal daily function of the different clinicalcentres participating to the study and to prevent the treat ofcontamination of the intervention protocol in the control group.The CONSORT statement extension to cluster analysis was,however, published after the start of the study, therefore not allmethodological requests reported in the statement are fulfilled,mainly in the sample size procedure (54). But clustering is andwill be taken into account in the analysis (52, 53).

In comparison with other studies such as Real.FR (8, 37),PLASA (55) and the ICTUS (56) studies following remarks canbe made:

While the population age is similar, only 3% of ourpopulation lives alone, but 31% in the PLASA study, 28% inthe Real.Fr study and 20% in the ICTUS study were livingalone. This might represent a cultural difference between southof France and northern Spain, with a different role of the familyin the care of the elders.

Even the patients were living at home, they are of moderatedementia stage according to CDR scores (0 = no impairment,0.5, 1, 2, and 3 indicating very mild, mild, moderate and severedementia respectively) (37), while in the 3 mentioned cohortsthey were of very mild to mild stage of dementia; CDR score 1,31% against 42% in Real.Fr study and 44% in the ICTUSstudy, while CDR score 2-3 represents 60% of our populationand only 22% and 13% in Real.Fr and ICTUS studiesrespectively.

Psychiatric disturbances, measured on the NPI, were alsomore frequent, and a graded level of problems was observedbetween ICTUS, Real.FR, PLASA studies and NutriAlzrespectively, with incidence of depression of 23%, 40%, 48%and 49%, and presence of apathy of 13%, 23%, 31% and 40%,respectively.

The presence of comorbid conditions was higher than in theICTUS study, 4.4 versus 1.4, The prevalence of hypertensionwas, however, similar (43% versus 39%), but prevalence ofdiabetes was somewhat higher (16% versus 11.8%).

We observed a rather high degree of dependence (IADL andADL scales), and compared to the Real.Fr study we observed agreater loss of independence in NutriAlz, 19% had no disabilityon the ADL scale, compared to 54%. Further only 6% weredependent on feeding in the Real.Fr study compared to 68% inthe present study. This was also observed in the percentage ofpatients at risk of malnutrition (MNA score <23.5), 35% and42%, respectively.

A higher degree of dependence was also observed by thelevel of caregiver burden, measured by a Zarit score of 21.1 ±14.7 for the ICTUS study, 22.6 ± 16 for the Real.Fr study and27.4 ± 15.5 in the present study. The caregivers were inmajority the spouse or children (88%) and rarely a friend(1.3%) or a paid caregiver (1.6%), as in the Real.Fr and PLASAstudies.

In conclusion, the NutriAlz baseline population was moredependent, showed a moderate to severe dementia stage, with ahigh risk of malnutrition, compared to the ICTUS, PLASA andReal.Fr studies. The advantage of the cluster study, nocontamination of the intervention program in the control group,is however shadowed by an intervention group which is slightlymore dependent, as measured by the ADL scale and thecaregiver burden (Zarit scale), and which shows more feedingproblems and a higher risk of malnutrition.

Author Contributions: Salvà A: Study concept and design, Acquisition of data,Analysis and interpretation of data, Drafting of the manuscript. Andrieu S.: Study conceptand design, Statistical analysis, Analysis and interpretation of data, Drafting of themanuscript. Fernandez E.: Study supervision, Acquisition of data, Data handling. SchiffrinE.J.: Study concept and design, Analysis and interpretation of data, Drafting of themanuscript. Moulin J.: Statistical analysis, Analysis of data. Decarli B.: Administrativesupport, Data handling, Analysis of data. Guigoz Y.: Analysis and interpretation of data,Drafting of the manuscript. Vellas B.: Study concept and design, Analysis andinterpretation of data, Drafting of the manuscript. NutriAlz Study Group: Acquisition ofdata

Acknowledgement: We thank the patients and their caregivers, as well as the studycentres for their participation. We thank MAPI-NAXIS for data handling, performing thecleaning of the database and performing the statistical analysis on the advice of J Moulinand S Andrieu.

Funding/Support: Nestlé Nutrition, Vevey, Switzerland.

Trial Registration: ClinicalTrials.gov Identifier: NCT00479843

Appendix A

NutriAlz Group: Carmen Espinosa. Hospital Sant Jaume. Mataró.Isabel Fort. Centre Socisanitari El Carme. BadalonaSalvador Altimir. Hospital Germans Tries i Pujol. BadalonaMercel Rossich. Institut Pere Mata. ReusJesús Ruiz. Policlínica de la Mercè. BarcelonaConsol Almenar. Benito Menni CASM. Sant BoiPau Sanchez. Consorci Sanitari Integral. HospitaletLluís Tàrraga. Fundació ACE. BarcelonaMiquel Aguilar. Hospital Mútua de TerrassaSecundí López Pousa. Institut D’assistència Sanitària. GironaSergio Ariño. Hospital de Granollers

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