MalnutritionNCT01776762
Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Geriatric Patients
A study testing Individual nutritional therapy in people with Malnutrition, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
Based on an established Follow-home-programme offered at discharge from hospital the aim of this study is to test a model of how nutritional intervention in elderly patients can be systematized and quality assured in the transition between sectors. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Individual nutritional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2013to Dec 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Geriatric medical patients
- Age +70 years
- Nutritional risk according to the level 1 screen in Nutritional Risk Screening 2002 (NRS2002)
- Nutritional therapy for at least 3 days and at least in two daily meals during the hospitalization period
- Participation in the standard Follow-home programme
Who cannot join
- Dementia
- Expected readmissions
- Terminal disease
- Non-danish speaking
- Not able to perform Hand grip test
- Planning weight reducing diet
Trial locations and contacts
1 site in 1 country.
Denmark1 site
EFFECT, Copenhagen University Hospital at Herlev
Herlev, Copenhagen, 2730
About this study
Official title: Effect of Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Undernourished Geriatric Medical Patients: a Randomized Controlled Trial.
Based on an established Follow-home-programme offered at discharge from hospital the aim of this study is to test a model of how nutritional intervention in elderly patients can be systematized and quality assured in the transition between sectors. Furthermore the aim is to demonstrate that this model has a positive effect on the functioning and well-being of the elderly patient.
The purpose of the Follow-home-programme is to facilitate the transition of the elderly patient between hospital and private home in order to follow-up on any medical, nursing- or retraining-related intervention necessary to the rehabilitation of the patient. However this offer does not focus on nutrition in particular. This is a problem as many elderly patients are known to develop a poor nutritional status due to low appetite, disease etc. Our hypothesis is that adding a systematic nutritional focus to the Follow-home intervention programme will promote the rehabilitation of the elderly patient further.
The nutritional intervention in our study will focus on improving energy- and protein intake and we will measure the effect on the patient's functional abilities, quality of life and rate of hospital readmissions. The intervention model will be based on individualized nutritional counselling by a registered dietician in the patients home.
Read the detailed description
The study is designed as a 12 week randomized, controlled intervention study. The study sample will consist of 80 geriatric patients admitted to a medical ward at Herlev University Hospital in Copenhagen, Denmark. The patients will be equally distributed into the control and the intervention group. The control group will follow the usual follow-home programme. The intervention group will also follow this programme, but will additionally be offered 3 home visits by a registered dietician. Interdisciplinary information exchange will take place through established communication channels eg. patient records, visitations.
Before and after the intervention data on the patient eg. hand-grip strength, nutritional status, dietary intake, functional abilities, well-being and activities of daily living will be gathered.
- Conditions
- Malnutrition
- Being tested
- Individual nutritional therapy
- Keywords
- Nutrition, Rehabilitation, Weightloss
- Medical subject headings
- Malnutrition, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual nutritional therapyDietary supplement
Individual nutritional therapy provided by registered dietician by means of three Home-visits
| Study group | Role | What they receive |
|---|---|---|
| Individual nutritional therapy | Experimental | Individual nutritional therapy provided by registered dietician by means of three Home-visits Receives: Dietary Supplement: Individual nutritional therapy |
| Standard Follow-home programme | No intervention | Standard Follow-home programme without individual nutritional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Measured: 12 weeks
Secondary outcomes (4)
Functional status
Chair stand, mobility, disability and rehabilitation capacity
Measured: 12 week
Nutritional status
Weight, BMI, energy and protein intake, distribution of protein intake
Measured: 12 weeks
Need of social services
Home care, home nursing, meals-on-wheels
Measured: 12 weeks
Readmissions
Measured: 6 months before and 1½ year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Investigator
- Enrolment
- 72 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
- Christian Bitz, Cand Scient, Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776762
- Sponsor's protocol ID
- EFFECT.B01.2012
- Status last verified
- Dec 2022
- First submitted
- 24 Jan 2013
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beck A, Andersen UT, Leedo E, Jensen LL, Martins K, Quvang M, Rask KO, Vedelspang A, Ronholt F. Does adding a dietician to the liaison team after discharge of geriatric patients improve nutritional outcome: a randomised controlled trial. Clin Rehabil. 2015 Nov;29(11):1117-28. doi: 10.1177/0269215514564700. Epub 2014 Dec 31.
PubMed 25552522Pohju A, Belqaid K, Brandt C, Lugnet K, Nielsen AL, et al. (2016) Adding a Dietitian to a Danish Liaison-Team after discharge of geriatric patients at nutritional risk may save health care costs. Aging Sci 4: 159.
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
- Effect of Nutritional Intervention in a Cross-sector Model for the Rehabilitation of Undernourished Geriatric Medical Patients: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01776762
- Acronym / sponsor ID
- EFFECT.B01.2012
- Conditions
- Malnutrition
- Keywords
- Nutrition, Rehabilitation, Weightloss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Jan 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.
Based on an established Follow-home-programme offered at discharge from hospital the aim of this study is to test a model of how nutritional intervention in elderly patients can be systematized and quality assured in the transition between sectors. Furthermore the aim is to demonstrate that this model has a positive effect on the functioning and well-being of the elderly patient.
The purpose of the Follow-home-programme is to facilitate the transition of the elderly patient between hospital and private home in order to follow-up on any medical, nursing- or retraining-related intervention necessary to the rehabilitation of the patient. However this offer does not focus on nutrition in particular. This is a problem as many elderly patients are known to develop a poor nutritional status due to low appetite, disease etc. Our hypothesis is that adding a systematic nutritional focus to the Follow-home intervention programme will promote the rehabilitation of the elderly patient further.
The nutritional intervention in our study will focus on improving energy- and protein intake and we will measure the effect on the patient's functional abilities, quality of life and rate of hospital readmissions. The intervention model will be based on individualized nutritional counselling by a registered dietician in the patients home.
Detailed description
The study is designed as a 12 week randomized, controlled intervention study. The study sample will consist of 80 geriatric patients admitted to a medical ward at Herlev University Hospital in Copenhagen, Denmark. The patients will be equally distributed into the control and the intervention group. The control group will follow the usual follow-home programme. The intervention group will also follow this programme, but will additionally be offered 3 home visits by a registered dietician. Interdisciplinary information exchange will take place through established communication channels eg. patient records, visitations.
Before and after the intervention data on the patient eg. hand-grip strength, nutritional status, dietary intake, functional abilities, well-being and activities of daily living will be gathered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual nutritional therapy | Experimental | Dietary Supplement: Individual nutritional therapyIndividual nutritional therapy provided by registered dietician by means of three Home-visits |
| Standard Follow-home programme | No intervention | –Standard Follow-home programme without individual nutritional therapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Geriatric medical patients
- Age +70 years
- Nutritional risk according to the level 1 screen in Nutritional Risk Screening 2002 (NRS2002)
- Nutritional therapy for at least 3 days and at least in two daily meals during the hospitalization period
- Participation in the standard Follow-home programme
Key exclusion criteria (6 listed)
- Dementia
- Expected readmissions
- Terminal disease
- Non-danish speaking
- Not able to perform Hand grip test
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 |
|---|---|---|
| Individual nutritional therapyIndividual nutritional therapy provided by registered dietician by means of three Home-visits | Dietary supplement | Individual nutritional therapy |
Primary outcome
Hand grip strength
Time frame: 12 weeks
4 secondary outcomes
Functional status
Time frame: 12 week
Nutritional status
Time frame: 12 weeks
Need of social services
Time frame: 12 weeks
Readmissions
Time frame: 6 months before and 1½ year after intervention
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.
- Background: PubMed 25552522Beck A, Andersen UT, Leedo E, Jensen LL, Martins K, Quvang M, Rask KO, Vedelspang A, Ronholt F. Does adding a dietician to the liaison team after discharge of geriatric patients improve nutritional outcome: a randomised controlled trial. Clin Rehabil. 2015 Nov;29(11):1117-28. doi: 10.1177/0269215514564700. Epub 2014 Dec 31.
- BackgroundPohju A, Belqaid K, Brandt C, Lugnet K, Nielsen AL, et al. (2016) Adding a Dietitian to a Danish Liaison-Team after discharge of geriatric patients at nutritional risk may save health care costs. Aging Sci 4: 159.
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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.
Christian Bitz, Cand Scient principal investigator
Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual nutritional therapy in people with Malnutrition, 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 5 inclusion and 6 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?
Hand grip strength (time frame: 12 weeks). 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 NCT01776762, which also lists 2 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.