AgingNCT00316966
A Clinical Trial to Determine Outcomes and Cost Effectiveness of Nutritional Intervention in Elderly Patients
A study testing Multidisciplinary dietary intervention in people with Aging, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
With the introduction of the National Insurance Law in Israel in 1995, there have been increased efforts to reduce hospitalization in general and length of stay in the hospital in particular. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Aging
- What is being tested?
- Multidisciplinary dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2003to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- All patients aged 65 or over admitted to one of three Internal Medicine Departments (A, C, F) at Soroka hospital during 18 months will be recruited
Who cannot join
- Having cancer, having cognitive function < 24, being clinically depressed and inability or unwillingness to sign an informed consent. In addition, due to the need for long-term intervention, only patients who live in the city of Beer-Sheva will be included. -
Trial locations and contacts
1 site in 1 country.
About this study
With the introduction of the National Insurance Law in Israel in 1995, there have been increased efforts to reduce hospitalization in general and length of stay in the hospital in particular. Under nourished patients have been shown to have a longer mean length of stay and they are more likely to suffer from complications, which significantly increase cost of care. Intense nutritional intervention programs, aimed at decreasing rehospitalizations and post hospitalization complications, are not clearly currently included in the basket of services provided under the law. Nutritional intervention has been shown to be clinically efficacious and cost-effective. Demonstration of the benefits of such intervention, both in terms of reduced expenditures and quality of care, may open a path for specific nutritional intervention programs that are needed for older persons during and after discharge from Acute Care. Given the effort made to reduce the length of hospitalization time, even in frail elderly patients, it is clear that full scale nutritional intervention cannot be completed during their hospitalization. Therefore, there is a need to create continuity between in-patient and follow-up nutritional intervention. This combined policy has the potential to improve general health, reduce the rates of under nutrition and its associated complications, and thus reduce future hospitalization, along with the mortality and morbidity associated. It is plausible that improved general health and less frequent hospitalization will eventuate in cost reduction and allow the intervention to be cost effective. Furthermore, the descriptive information regarding the nutritional status of older patients admitted to an Acute Care department may be important for policy makers in their development of nutritional intervention programs to support the elderly before, during and after hospitalization.
Study Hypothesis:
We hypothesize that multidisciplinary nutritional intervention, during and following hospitalization, will improve dietary intake and nutritional status. Improvement in nutritional status will, in turn, cut health care costs by decreasing the use of health services. In-hospital nutritional care will be beneficial, but combined in-hospital and community care will be more clinically efficacious and more cost effective in the long run.
Read the detailed description
Hospitalized elderly are susceptible to under nutrition, affecting their clinical course and outcome. We recently found 30% under nutrition in 200 inpatients aged 65 and older. Interestingly few, if any, of these patients recieved nutritional intervention while hospitalized.
Objectives: 1. To develop models for nutritional intervention among under nourished elderly inpatients.
- To determine the impact of the intervention programs and compare them to standard care. Prospective outcomes include health care use, health and nutritional status and dietary intake in the year following hospitalization.
- To assess the cost-effectiveness and clinical feasibility of the nutritional interventions proposed.
Methods: Patients over 70 years of age, admitted to the Internal Medicine Department at Soroka University Hospital will be screened for nutritional risk. Patients at risk will be randomly allocated to 3 groups: standard care, in-hospital intensive intervention and in-hospital and community intensive intervention. In the year following their hospitalization, health status, health care use, quality of life and nutritional status will be assessed using validated tools.
Importance of the study: Under nourished patients are at increased risk for medical complications and increased duration of hospitalization, both of which raise the cost of care. Intensive nutritional intervention may reduce length of stay and thus costs. A formalized intervention plan is crucial for efficacious cost-effective care. We feel that acute hospitalization is a window of opportunity for initiating long-term nutritional advice and follow-up.
- Conditions
- Aging
- Being tested
- Multidisciplinary dietary intervention
- Keywords
- Nutritional status, dietary intervention, health care use, costs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary dietary interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care use
Nutritional status
Secondary outcomes (2)
Dietary intake
Blood measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Danit R Shahar, PhD, Principal investigator, Ben-Gurion University, Beer-Sheva, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316966
- Sponsor's protocol ID
- sor323202ctil
- Status last verified
- May 2005
- First submitted
- 20 Apr 2006
- Last updated
- 10 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Determine Outcomes and Cost Effectiveness of Nutritional Intervention in Elderly Patients
- ClinicalTrials.gov ID
- NCT00316966
- Acronym / sponsor ID
- sor323202ctil
- Conditions
- Aging
- Keywords
- Nutritional status, dietary intervention, health care use, costs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jun 2003
- First posted
- 21 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the introduction of the National Insurance Law in Israel in 1995, there have been increased efforts to reduce hospitalization in general and length of stay in the hospital in particular. Under nourished patients have been shown to have a longer mean length of stay and they are more likely to suffer from complications, which significantly increase cost of care. Intense nutritional intervention programs, aimed at decreasing rehospitalizations and post hospitalization complications, are not clearly currently included in the basket of services provided under the law. Nutritional intervention has been shown to be clinically efficacious and cost-effective. Demonstration of the benefits of such intervention, both in terms of reduced expenditures and quality of care, may open a path for specific nutritional intervention programs that are needed for older persons during and after discharge from Acute Care. Given the effort made to reduce the length of hospitalization time, even in frail elderly patients, it is clear that full scale nutritional intervention cannot be completed during their hospitalization. Therefore, there is a need to create continuity between in-patient and follow-up nutritional intervention. This combined policy has the potential to improve general health, reduce the rates of under nutrition and its associated complications, and thus reduce future hospitalization, along with the mortality and morbidity associated. It is plausible that improved general health and less frequent hospitalization will eventuate in cost reduction and allow the intervention to be cost effective. Furthermore, the descriptive information regarding the nutritional status of older patients admitted to an Acute Care department may be important for policy makers in their development of nutritional intervention programs to support the elderly before, during and after hospitalization.
Study Hypothesis:
We hypothesize that multidisciplinary nutritional intervention, during and following hospitalization, will improve dietary intake and nutritional status. Improvement in nutritional status will, in turn, cut health care costs by decreasing the use of health services. In-hospital nutritional care will be beneficial, but combined in-hospital and community care will be more clinically efficacious and more cost effective in the long run.
Detailed description
Hospitalized elderly are susceptible to under nutrition, affecting their clinical course and outcome. We recently found 30% under nutrition in 200 inpatients aged 65 and older. Interestingly few, if any, of these patients recieved nutritional intervention while hospitalized.
Objectives: 1. To develop models for nutritional intervention among under nourished elderly inpatients.
- To determine the impact of the intervention programs and compare them to standard care. Prospective outcomes include health care use, health and nutritional status and dietary intake in the year following hospitalization.
- To assess the cost-effectiveness and clinical feasibility of the nutritional interventions proposed.
Methods: Patients over 70 years of age, admitted to the Internal Medicine Department at Soroka University Hospital will be screened for nutritional risk. Patients at risk will be randomly allocated to 3 groups: standard care, in-hospital intensive intervention and in-hospital and community intensive intervention. In the year following their hospitalization, health status, health care use, quality of life and nutritional status will be assessed using validated tools.
Importance of the study: Under nourished patients are at increased risk for medical complications and increased duration of hospitalization, both of which raise the cost of care. Intensive nutritional intervention may reduce length of stay and thus costs. A formalized intervention plan is crucial for efficacious cost-effective care. We feel that acute hospitalization is a window of opportunity for initiating long-term nutritional advice and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- All patients aged 65 or over admitted to one of three Internal Medicine Departments (A, C, F) at Soroka hospital during 18 months will be recruited
Key exclusion criteria (1 listed)
- Having cancer, having cognitive function < 24, being clinically depressed and inability or unwillingness to sign an informed consent. In addition, due to the need for long-term intervention, only patients who live in the city of Beer-Sheva will be included. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary dietary intervention | Behavioural | – |
Primary outcome
Health care use
Nutritional status
2 secondary outcomes
Dietary intake
Blood measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danit R Shahar, PhD principal investigator
Ben-Gurion University, Beer-Sheva, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary dietary intervention in people with Aging, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health care use. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.