Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000340538
Ethics application status
Approved
Date submitted
3/01/2015
Date registered
14/04/2015
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nutritional intervention among geriatric patients residing at home, randomized controlled trial (RCT)
Scientific title
Nutritional intervention compared to normal care among geriatric patients during six months period in protein intake and quality of life
Secondary ID [1] 285905 0
None
Universal Trial Number (UTN)
U1111-1165-6543
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geriatric patients recovering from acute illness and discharged from hospital to home 293822 0
Malnutrition 293823 0
Condition category
Condition code
Diet and Nutrition 294125 294125 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in this study are people over 65 years of age and who are recovering from an acute illness after hospitalization. Intervention includes six months tailored nutritional guidance and individual home sessions administered by a dietitian. First one-hour visit takes place after discharge from rehabilitation center and then the dietitian evaluates the need for further one hour guidance sessions, max. 3 sessions. Guidance is based on food diaries, the results of the baseline measurements, home visits, and discussions with the participants and their possible caregivers. Oral nutritional supplement are advised to use and given to participants when food and protein intakes are low. The intervention will be a process which responds and continues step by step according to participants’ individual needs. Adherence is monitored by the consumption of dietary supplements and checking protein intake at 3 months point in the intervention.
Intervention code [1] 290881 0
Rehabilitation
Intervention code [2] 290882 0
Treatment: Other
Comparator / control treatment
Persons in the control group will receive written nutritional information after randomization and at the end of the trial handbooks about good nutrition and good sources of protein for the aged people.
Control group
Active

Outcomes
Primary outcome [1] 293927 0
Protein intake is assessed by 3 day food diaries and analysed Fineli (www.fineli.fi)
Timepoint [1] 293927 0
6 months
Primary outcome [2] 293928 0
Quality of life with 15D
Timepoint [2] 293928 0
6 months
Secondary outcome [1] 312158 0
Nutritional status with MNA
Timepoint [1] 312158 0
6 months
Secondary outcome [2] 312159 0
Grip strength using a handgrip dynamometer
Timepoint [2] 312159 0
6 months
Secondary outcome [3] 312160 0
Muscle strength with 5 times chair rise and 5 meters walk
Timepoint [3] 312160 0
6 months
Secondary outcome [4] 312161 0
Balance test used Romberg's test
Timepoint [4] 312161 0
6 months
Secondary outcome [5] 312162 0
Body composition by DEXA scan
Timepoint [5] 312162 0
6 months
Secondary outcome [6] 312163 0
Cognition with MMSE
Timepoint [6] 312163 0
6 months
Secondary outcome [7] 312164 0
Use of health and social services by data linkage to patient medical and social records
Timepoint [7] 312164 0
12 months
Secondary outcome [8] 312165 0
Mortality
Timepoint [8] 312165 0
24 months
Secondary outcome [9] 313056 0
Cost effectiveness of nutritional care by the use of health and social services by data linkage to patient medical and social records
Timepoint [9] 313056 0
12 months

Eligibility
Key inclusion criteria
age > 65 years, recovering from acute illness, able to return home from rehabilitation
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Disease probably leading to death in less than six months, dementia

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
Completed
Date of first participant enrolment
Anticipated
2/02/2015
Actual
26/03/2015
Date of last participant enrolment
Anticipated
30/09/2015
Actual
29/09/2015
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
102
Accrual to date
Final
41
Recruitment outside Australia
Country [1] 6575 0
Finland
State/province [1] 6575 0

Funding & Sponsors
Funding source category [1] 290486 0
Government body
Name [1] 290486 0
Finlands Slot Machine Association
Country [1] 290486 0
Finland
Primary sponsor type
Commercial sector/Industry
Name
Nutricia Medical in Finland
Address
Nutricia Medical Oy
Linnankatu 26 A
20100 TURKU
Country
Finland
Secondary sponsor category [1] 289187 0
Charities/Societies/Foundations
Name [1] 289187 0
Society for Gerontological Nutrition in Finland
Address [1] 289187 0
Toinen linja 3, 00530 Helsinki
Country [1] 289187 0
Finland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308711 0
Ethics Committee of Medicine
Ethics committee address [1] 308711 0
PL 348, 00029 HUS
Ethics committee country [1] 308711 0
Finland
Date submitted for ethics approval [1] 308711 0
23/02/2015
Approval date [1] 308711 0
26/02/2015
Ethics approval number [1] 308711 0
305/13/03/01/14

Summary
Brief summary
The aim of this study is to 1) assess nutritional status, protein and nutrient intake and functional capacity, 2) investigate the effectiveness of tailored nutritional care with randomised, controlled design, 3) assess the cost effectiveness of nutritional care and 4) implement nutritional care as a part of rehabilitation and cope at home of older patients who are recovering from acute illnesses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53758 0
A/Prof Merja Suominen
Address 53758 0
Society for Gerontological Nutrition in Finland
Toinen linja 3, 00530 Helsinki
Country 53758 0
Finland
Phone 53758 0
+358505841995
Fax 53758 0
Email 53758 0
merja.suominen@gery.fi
Contact person for public queries
Name 53759 0
Merja SUominen
Address 53759 0
Society for Gerontological Nutrition in Finland
Toinen linja 3, 00530 Helsinki
Country 53759 0
Finland
Phone 53759 0
+358505841995
Fax 53759 0
Email 53759 0
merja.suominen@gery.fi
Contact person for scientific queries
Name 53760 0
Merja Suominen
Address 53760 0
Society for Gerontological Nutrition in Finland
Toinen linja 3, 00530 Helsinki
Country 53760 0
Finland
Phone 53760 0
+358505841995
Fax 53760 0
Email 53760 0
merja.suominen@gery.fi

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11965Study protocol  merja.suominen@gery.fi
11966Ethical approval  merja.suominen@gery.fi
11967Informed consent form  merja.suominen@gery.fi



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.