Frail Older AdultsCESNCT01873456
Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?
A study testing multifactorial nutritional intervention in people with Frail Older Adults, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
The hypothesis is that there is a profit potential by implementing a multifactorial nutritional intervention among frail elderly since this will result in an improved nutritional status, functional capacity and improved quality of life. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Older Adults
- What is being tested?
- multifactorial nutritional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jul 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Screening for nutritional risk
Who cannot join
- terminal condition or do not wish to participate
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis is that there is a profit potential by implementing a multifactorial nutritional intervention among frail elderly since this will result in an improved nutritional status, functional capacity and improved quality of life.
- Conditions
- Frail Older Adults
- Being tested
- multifactorial nutritional intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multifactorial nutritional interventionOther
Also called dietician, resitance type exercise, dysphagia assessment and treatment
| Study group | Role | What they receive |
|---|---|---|
| Multifactorial nutritional intervention | Experimental | dietician, resistance type exercise, dysphagia assessment and treatment Receives: Other: multifactorial nutritional intervention |
| usual care | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
EuroQol (EQ-5D) is a questionnaire with five questions to be answered in three categories. The five questions deal of movement, self-care, usual activities, pain / discomfort and anxiety / depression and any problems with this
Measured: up to 6 months
Secondary outcomes (5)
Nutritional status
Assessment of weight
Measured: up to 6 months
Hand grip strength
Residents and clients hand grip strength is determined using the dynamometer The dynamometer consists of a narrow handle with two strings as the older must squeezing so hard, they manage three times. The highest value will be used.
Measured: up to 6 months
Costs
Here is used information on additional costs of nutrition efforts, which on the one hand involves all costs associated with the effort, while on the other hand also be seen on the savings that can be attached to the outcome of the effort. Since the purpose is to illustrate the cost-effectiveness, the net profit on the cost side is also compared with the effect of nutritional intervention in terms of improved quality of life, and hence would be able to shed light on efforts from both resource use and a health effect
Measured: up to 6 months
Activities of Daily Living and cognitive performance
Data is collected by Means of the resident assessment instrument
Measured: up to 6 months
physical strength
30 seconds chair stand is used
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Frail Older AdultsStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Bitz, Copenhagen University Hospital at Herlev
- Investigators
- Anne Marie Beck, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873456
- Sponsor's protocol ID
- CES1
- Acronym
- CES
- Status last verified
- Dec 2022
- First submitted
- 29 May 2013
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Beck AM, Keiding H, Christensen AG, Hansen BS, Svendsen SD, et al. (2015) Multidisciplinary Nutritional Support for Page 2 of 7 Undernutrition in Older Adults in Nursing Home and Home-Care is Cost-Effective. SOJ Nur Health Care 1(1): 1-7.
Beck AM, Gogsig Christensen A, Stenbaek Hansen B, Damsbo-Svendsen S, Kreinfeldt Skovgaard Moller T, Boll Hansen E, Keiding H. Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial. Nutr J. 2014 Aug 28;13:86. doi: 10.1186/1475-2891-13-86.
PubMed 25163483Beck AM, Christensen AG, Hansen BS, Damsbo-Svendsen S, Moller TK. Multidisciplinary nutritional support for undernutrition in nursing home and home-care: A cluster randomized controlled trial. Nutrition. 2016 Feb;32(2):199-205. doi: 10.1016/j.nut.2015.08.009. Epub 2015 Sep 3.
PubMed 26553461
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Multifactorial Nutritional Treatment for Undernutrition in Older Adults in Primary Care Cost-effective?
- ClinicalTrials.gov ID
- NCT01873456
- Acronym / sponsor ID
- CES / CES1
- Conditions
- Frail Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Jun 2013 (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.
The hypothesis is that there is a profit potential by implementing a multifactorial nutritional intervention among frail elderly since this will result in an improved nutritional status, functional capacity and improved quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifactorial nutritional intervention | Experimental | Other: multifactorial nutritional interventiondietician, resistance type exercise, dysphagia assessment and treatment |
| usual care | No intervention | –usual care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Screening for nutritional risk
Key exclusion criteria (1 listed)
- terminal condition or do not wish to participate
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 |
|---|---|---|
| multifactorial nutritional interventionAlso: dietician, resitance type exercise, dysphagia assessment and treatment | Other | Multifactorial nutritional intervention |
Primary outcome
Quality of life
Time frame: up to 6 months
EuroQol (EQ-5D) is a questionnaire with five questions to be answered in three categories. The five questions deal of movement, self-care, usual activities, pain / discomfort and anxiety / depression and any problems with this
5 secondary outcomes
Nutritional status
Time frame: up to 6 months
Hand grip strength
Time frame: up to 6 months
Costs
Time frame: up to 6 months
Activities of Daily Living and cognitive performance
Time frame: up to 6 months
physical strength
Time frame: up to 6 months
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 21 Dec 2022.
- BackgroundBeck AM, Keiding H, Christensen AG, Hansen BS, Svendsen SD, et al. (2015) Multidisciplinary Nutritional Support for Page 2 of 7 Undernutrition in Older Adults in Nursing Home and Home-Care is Cost-Effective. SOJ Nur Health Care 1(1): 1-7.
- Results publication: PubMed 25163483Beck AM, Gogsig Christensen A, Stenbaek Hansen B, Damsbo-Svendsen S, Kreinfeldt Skovgaard Moller T, Boll Hansen E, Keiding H. Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial. Nutr J. 2014 Aug 28;13:86. doi: 10.1186/1475-2891-13-86.
- Results publication: PubMed 26553461Beck AM, Christensen AG, Hansen BS, Damsbo-Svendsen S, Moller TK. Multidisciplinary nutritional support for undernutrition in nursing home and home-care: A cluster randomized controlled trial. Nutrition. 2016 Feb;32(2):199-205. doi: 10.1016/j.nut.2015.08.009. Epub 2015 Sep 3.
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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.
Anne Marie Beck principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multifactorial nutritional intervention in people with Frail Older Adults, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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 21 Dec 2022. 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 Denmark. 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?
Quality of life (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01873456, which also lists 3 linked publications.
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 21 Dec 2022.