ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000018910

Ethics application status

Approved

Date submitted

16/12/2010

Date registered

6/01/2011

Date last updated

12/01/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Nutritional treatment of aged individuals with Alzheimer disease living at home with their spouses – randomized controlled intervention trial

Scientific title

Effect of tailored nutritional treatment of aged individuals with Alzheimer disease living at home with their spouses – randomized controlled intervention trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Alzheimer disease

Malnutrition

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Neurological

Dementias

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In intervention the nutritional care will be provided tailored and comprehensively to the couple (age 65 + both), a person with Alzheimer disease living together with an aged spouse.
The nutritionist meets the intervention couples at least 3 times in their homes during one year and when needed additional telephone contact or home visit. Nutritionist will discuss with them about nutritional matters and give individual nutrition counselling. Based on the meeting and food diaries the intervention couple will receive a nutritional plan in which individual nutritonal advice is given.
Particularly in connection with acute diseases and in situations requiring hospital treatment, attention should be paid to intensified nutritional care. Nutritional supplements are given when necessary. Spouses have possibilities to meet each others and the nutritionist in group meetings three times during the intervention and discuss about nutritional matters and challenges at home.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Couples in the control group will receive written nutritional information once after randomization and at the end of the trial 2 handbooks about good nutrition and good sources of protein for the aged people.

Control group

Active

Outcomes

Primary outcome [1]

The weight change between the intervention and control groups. Couples in the intervention and control goups will be weighed at the beginning, 6 and 12 months after randomization with a scale (ADE M30014).

Timepoint [1]

6 and 12 months after randomization

Secondary outcome [1]

Nutritional status of both the spouse and the Alzheimer-patient will be assessed with the Mini Nutritional Assessment test (MNA).

Timepoint [1]

In the beginning and 12 months after randomisation

Secondary outcome [2]

energy, protein and nutrient intake retrieved from food diaries

Timepoint [2]

In the beginning and 12 months after randomisation

Secondary outcome [3]

Cognition of Alzheimer-patient and the spouse will be assessed with the Minimental State Examination (MMSE) The state of dementia of Alzheimer-patient will be assessed with Clinical Dementia Rating Scale (CDR).

Timepoint [3]

In the beginning and 12 months after randomisation

Secondary outcome [4]

Behavioural and psychological symptoms of dementia (BPSD) will be assessed with Neuropsychiatric Inventory (NPI). The caregivers burden will be assessed with Zarit-test.

Timepoint [4]

In the beginning and 12 months after randomisation

Secondary outcome [5]

Health-related quality of life will be assessed using the 15D instrument

Timepoint [5]

In the beginning and 12 months after randomisation

Secondary outcome [6]

The use of health services (cost-effectiveness) will be assessed with the questionnaire and medical records data.

Timepoint [6]

12 months after randomisation

Secondary outcome [7]

Functional ability will be assessed with IADL (Instrumental activities of daily living)

Timepoint [7]

In the beginning and 12 months after randomisation

Eligibility

Key inclusion criteria

A person with Alzheimer disease (medication with the code 307 by Kela, the Social Insurance Institution of Finland) living at home together with an aged spouse
age no less than 65 years (both spouses)
informed consent obtained from the Alzheimer-patient and his/her spouse

Minimum age

65 Years

Maximum age

100 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Disease probably leading to death in less than six months

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/11/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

240

Accrual to date

Final

Recruitment outside Australia

Country [1]

Finland

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Finlands Slot Machine Association

Address [1]

RAY, PL 35, 00521 Helsinki

Country [1]

Finland

Primary sponsor type

Charities/Societies/Foundations

Name

Society for Memory Disorders Expertise in Finland

Address

Fredriksberginkatu 2
00240 Helsinki

Country

Finland

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Helsinki and Uusimaa Hospital District Ethics Committee (coordinating body)

Ethics committee address [1]

Helsinki and Uusimaa Hospital District Ethics Committee
BOX 100
00029 HUS
Finland

Ethics committee country [1]

Finland

Date submitted for ethics approval [1]

Approval date [1]

22/09/2009

Ethics approval number [1]

229/13/03/00/2009

Summary

Brief summary

Effect of tailored nutritional treatment of aged individuals with Alzheimer disease living at home with their spouses – randomized controlled intervention trial

Impaired nutritional status is associated with many diseases, such as Alzheimer disease, depression, stroke, falling, hip fractures and pressure sores. In aged people, weight loss and malnutrition are health risks that should be addressed immediately. One of the first symptoms of memory disorder is often weight loss accelerating sarcopenia and loss of functional ability. Elderly individuals with Alzheimer disease living at home with their spouses are important target groups for nutritional care, because it may support their nutritional status and well-being and make it possible to live at home longer. Individual assessment of nutritional status and food intake, as well as planning of tailored nutritional care, are important in order to maintain a good nutritional status in an aged person. Only few studies have been carried out on this issue but they have suggested that nutritional care has been proved effective on health, quality of life, functional ability and use of health services among elderly with Alzheimer disease living at home with their elderly spouses. This is the first study in the Finnish setting. 

The aim of the trial is to find out whether tailored nutritional treatment of aged persons (1) with Alzheimer disease living with their (2) aged spouses at home could be used to affect their
-	nutritional status 
-	energy, protein and nutrient intake retrieved from food diaries
-	body mass index (BMI)
-	functional ability
-	mental functioning 
-	social isolation and psychosocial wellbeing 
-	health-related quality of life, and 
-	the use of health services (cost-effectiveness)
The hypothesis is that tailored nutritional treatment has a positive impact on nutritional parameters, health, wellbeing, caregiver burden and the use of health services among home-dwelling elderly people with (1) Alzheimer disease and their (2) spouses.

The study will be a randomized intervention trial. 200 couples in which the spouse takes care of his/her Alzheimer patient companion at home will be recruited. The present research creates new and detailed knowledge of tailored nutritional intervention possibilities among home-dwelling aged people with Alzheimer-disease and other diseases. Results from the trial will be highly relevant for the development of nutritional care of elderly living at home. This helps nutritionists and health/social care professionals to focus nutritional intervention methods and increase their knowledge in preventing malnutrition and its adverse affects. The study provides detailed information on how the tailored nutritional intervention can be performed in home setting.

Trial website

http://www.ravitsemuskotona.fi/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Merja Suominen

Address

Fredriksberginkatu 2
00240 Helsinki

Country

Finland

Phone

+358503081990

Fax

merja.suominen@muistiasiantuntijat.fi

Contact person for scientific queries

Name

Merja Suominen

Address

Fredriksberginkatu 2
00240 Helsinki

Country

Finland

Phone

+358503081990

Fax

merja.suominen@muistiasiantuntijat.fi

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Nutritional treatment of aged individuals with Alzheimer disease living at home with their spouses: study protocol for a randomized controlled trial.	2012	https://dx.doi.org/10.1186/1745-6215-13-66

N.B. These documents automatically identified may not have been verified by the study sponsor.

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