Trial Review

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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] 253304 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer disease 258836 0
Malnutrition 258837 0
Condition category
Condition code
Diet and Nutrition 258974 258974 0 0
Other diet and nutrition disorders
Neurological 258975 258975 0 0
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] 257752 0
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] 259829 0
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] 259829 0
6 and 12 months after randomization
Secondary outcome [1] 268660 0
Nutritional status of both the spouse and the Alzheimer-patient will be assessed with the Mini Nutritional Assessment test (MNA).
Timepoint [1] 268660 0
In the beginning and 12 months after randomisation
Secondary outcome [2] 268661 0
energy, protein and nutrient intake retrieved from food diaries
Timepoint [2] 268661 0
In the beginning and 12 months after randomisation
Secondary outcome [3] 268662 0
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] 268662 0
In the beginning and 12 months after randomisation
Secondary outcome [4] 268663 0
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] 268663 0
In the beginning and 12 months after randomisation
Secondary outcome [5] 268664 0
Health-related quality of life will be assessed using the 15D instrument
Timepoint [5] 268664 0
In the beginning and 12 months after randomisation
Secondary outcome [6] 268665 0
The use of health services (cost-effectiveness) will be assessed with the questionnaire and medical records data.
Timepoint [6] 268665 0
12 months after randomisation
Secondary outcome [7] 268701 0
Functional ability will be assessed with IADL (Instrumental activities of daily living)
Timepoint [7] 268701 0
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?
No
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] 3095 0
Finland
State/province [1] 3095 0

Funding & Sponsors
Funding source category [1] 258222 0
Charities/Societies/Foundations
Name [1] 258222 0
Finlands Slot Machine Association
Country [1] 258222 0
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] 257389 0
None
Name [1] 257389 0
Address [1] 257389 0
Country [1] 257389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260204 0
Helsinki and Uusimaa Hospital District Ethics Committee (coordinating body)
Ethics committee address [1] 260204 0
Ethics committee country [1] 260204 0
Finland
Date submitted for ethics approval [1] 260204 0
Approval date [1] 260204 0
22/09/2009
Ethics approval number [1] 260204 0
229/13/03/00/2009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32021 0
Address 32021 0
Country 32021 0
Phone 32021 0
Fax 32021 0
Email 32021 0
Contact person for public queries
Name 15268 0
Merja Suominen
Address 15268 0
Fredriksberginkatu 2
00240 Helsinki
Country 15268 0
Finland
Phone 15268 0
+358503081990
Fax 15268 0
Email 15268 0
[email protected]
Contact person for scientific queries
Name 6196 0
Merja Suominen
Address 6196 0
Fredriksberginkatu 2
00240 Helsinki
Country 6196 0
Finland
Phone 6196 0
+358503081990
Fax 6196 0
Email 6196 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseNutritional treatment of aged individuals with Alzheimer disease living at home with their spouses: study protocol for a randomized controlled trial.2012https://dx.doi.org/10.1186/1745-6215-13-66
N.B. These documents automatically identified may not have been verified by the study sponsor.