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Trial registered on ANZCTR


Registration number
ACTRN12612000400864
Ethics application status
Approved
Date submitted
3/04/2012
Date registered
10/04/2012
Date last updated
10/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of the effectiveness of post-discharge telecare and home visits for malnourished adult patients admitted to acute care hospital
Scientific title
In adult malnourished patients admitted to hospital for acute care, do ambulatory nutrition support services (combined outpatient visits, home visits and telecare) improve the nutrition status of patients better than standard outpatient dietetics clinics?
Secondary ID [1] 280271 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 286219 0
Condition category
Condition code
Diet and Nutrition 286435 286435 0 0
Other diet and nutrition disorders
Public Health 286461 286461 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individually tailored nutrition planning by a dietitian before discharge from the hospital. The content of the diet intervention before discharge involved dietary counseling to meet the deficit in protein, calorie and other nutrient intake.
Oral nutrition supplements will be prescribed for patients who require them.
In the intervention group, outpatient follow-ups and telephone nutrition support will be provided for 5 months. The first follow-up with a telephone call will take place 1 week after discharge from the hospital. Outpatient appointments will be scheduled at the 1st month, 3rd month and 5th month. If patients fail to turn up at the outpatient clinic, home visits will be arranged within one week of the missed appointments. Patients will not receive any home visits if they attend all their outpatient appointments. All the outpatient follow-up at the clinic and home visits will be administered a dietitian on a one-to-one basis and lasts about 30 minutes. Telephone follow-up by a dietetic assistant will be scheduled at the 2nd month, 4th month and every 2 weeks for patients who do not make improvement in oral intake.
Intervention code [1] 284641 0
Treatment: Other
Intervention code [2] 284642 0
Rehabilitation
Comparator / control treatment
Simlarly in the control group, individually tailored nutrition planning by a dietitian before discharge from the hospital will be administered. The content of the diet intervention before discharge involved dietary counseling to meet the deficit in protein, calorie and other nutrient intake.
Oral nutrition supplements will be prescribed for patients who require them.

Appointments for follow-up with the dietitians at outpatient clinic will be provided at the 1st month, 3rd month and 5th month. Reminders will be sent to the participants on the appointments regardless of attendance to match the potential number of "face-to-face" contacts as the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 286880 0
Nutrition status assessed using Subjective Global Assessment (SGA)
Timepoint [1] 286880 0
At baseline and 5th month
Primary outcome [2] 286881 0
Body weight
Timepoint [2] 286881 0
At baseline and 5th month
Primary outcome [3] 286882 0
Upper arm anthropometrics i.e. Mid arm circumference, triceps skinfold thickness and mid arm muscle circumference
Timepoint [3] 286882 0
At baseline and 5th month
Secondary outcome [1] 296899 0
Functional status using Handgrip dynamometer
Timepoint [1] 296899 0
At baseline and 5th month
Secondary outcome [2] 296900 0
Quality of Life using the Visual Analogue Scale and Scores of EuroQOL
Timepoint [2] 296900 0
At baseline and 5th month
Secondary outcome [3] 296901 0
All-cause mortality
Timepoint [3] 296901 0
At 0.5 year, 1 year, 2 years and 3 years after the 5th month.
Secondary outcome [4] 296902 0
Readmission rate from the hospital's System Application Product (SAP) system
Timepoint [4] 296902 0
At 0.5 year, 1 year, 2 years and 3 years after the 5th month.
Secondary outcome [5] 296903 0
Total length of hospital stay from the hospital's Computerised Patient Support System (CPSS)
Timepoint [5] 296903 0
At 0.5 year, 1 year, 2 years and 3 years after the 5th month.
Secondary outcome [6] 296904 0
Total cost of hospitalisation from the hospital's System Application Product (SAP) system
Timepoint [6] 296904 0
At 0.5 year, 1 year, 2 years and 3 years after the 5th month.

Eligibility
Key inclusion criteria
Adult > 21 years old; admitted for acute care to the hospital; assessed by dietitians as malnourished using SGA at the point of discharge or less than 4 days before discharge.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients on tube feeding or total parenteral nutrition upon discharge; patients on palliative care or with terminal illness; live outside of Singapore; have severe cognitive, psychological disabilities; discharged to another healthcare or step-down care facility or nursing home or unwilling to provide informed consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes prepared by a third party who is not involved in patient intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomization by gender, age (>= 65 years old) and nutritional status (moderate vs severe) will be effected using sealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 4239 0
Singapore
State/province [1] 4239 0
Singapore

Funding & Sponsors
Funding source category [1] 285037 0
Government body
Name [1] 285037 0
Healthcare Quality Initiative and Innovation Fund
Country [1] 285037 0
Singapore
Primary sponsor type
Individual
Name
Lim Su Lin
Address
Dietetics Department,
National University Hospital,
5 Lower Kent Ridge Road,
Level 1, Main Building,
Singapore 119074
Country
Singapore
Secondary sponsor category [1] 283899 0
Hospital
Name [1] 283899 0
National University Hospital
Address [1] 283899 0
5 Lower Kent Ridge Road,
Singapore 119074
Country [1] 283899 0
Singapore
Other collaborator category [1] 260699 0
Individual
Name [1] 260699 0
Lynne Daniels
Address [1] 260699 0
Exercise and Nutrition Sciences, Faculty Health Institute Health and Biomedical Innovation, Queensland Institute of Technology, Victoria Park Rd, Kelvin Grove, Queensland 4059, Australia
Country [1] 260699 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287041 0
National Healthcare Group Domain Specific Review Board
Ethics committee address [1] 287041 0
Domain Specific Review Board D - Research & Development Office, National Healthcare Group, 6 Commonwealth Lane #04-01 GMTI Building, Singapore 149547
Ethics committee country [1] 287041 0
Singapore
Date submitted for ethics approval [1] 287041 0
Approval date [1] 287041 0
06/05/2011
Ethics approval number [1] 287041 0
D/11/047

Summary
Brief summary
To evaluate the effectiveness of alternative model of ambulatory nutrition support services via a randomised controlled trial which will compare combined home visits, outpatient follow-up and telephone nutrition support services with standard hospital outpatient clinics.The hypothesis of this study is that malnourished patients receiving nutrition support post-hospitalisation will benefit from novel ways of nutrition support delivery and hence improve their nutritional, functional and health outcomes; at the same time reducing unplanned readmission rate, length of hospital stay and mortality and cost.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34018 0
Address 34018 0
Country 34018 0
Phone 34018 0
Fax 34018 0
Email 34018 0
Contact person for public queries
Name 17265 0
Lim Su Lin
Address 17265 0
Dietetics Department,
National University Hospital,
5 Lower Kent Ridge Road,
Singapore 119074
Country 17265 0
Singapore
Phone 17265 0
+65 67724580
Fax 17265 0
+65 67791938
Email 17265 0
[email protected]
Contact person for scientific queries
Name 8193 0
Lim Su Lin
Address 8193 0
Dietetics Department,
National University Hospital,
5 Lower Kent Ridge Road,
Singapore 119074
Country 8193 0
Singapore
Phone 8193 0
+65 67724580
Fax 8193 0
+65 67791938
Email 8193 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

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