MalnutritionOHENCT01249716
Follow-up Home Visits With Nutrition
A study testing individual nutritional therapy in people with Malnutrition, run by University of Copenhagen at 1 site in Denmark.
Trial summary
To assess the effect on geriatric patients of follow-up home visit including nutrition. The hypothesis is that this can prevent hospital readmissions, and has a positive impact on functional abilities and 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
- Malnutrition
- What is being tested?
- individual nutritional therapy
- How many people
- 152 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2010to Mar 2012
- 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
- Geriatric patients in nutritional risk
Who cannot join
- Dementia
- Expected readmissions
- Terminal disease
- Non-Danish speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up Home Visits With Nutrition (OHE)
To assess the effect on geriatric patients of follow-up home visit including nutrition.
The hypothesis is that this can prevent hospital readmissions, and has a positive impact on functional abilities and quality of life
Read the detailed description
Before and after the intervention the participants nutritional status, hand grip strength, functional abilities, well-being, dietary intake, level of tiredness,and activities of daily living will be assessed
- Conditions
- Malnutrition
- Being tested
- individual nutritional therapy
- Keywords
- follow-up home visit, Geriatric Disorder, rehabilitation
- Medical subject headings
- Malnutrition
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 a registered dietician by means of three follow-up home visits
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital readmissions
Measured: one year
Secondary outcomes (1)
body weight
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2012
- Study completionMar 2012
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 MalnutritionStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AAstrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249716
- Sponsor's protocol ID
- 22
- Acronym
- OHE
- Status last verified
- Mar 2012
- First submitted
- 29 Nov 2010
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beck AM, Kjaer S, Hansen BS, Storm RL, Thal-Jantzen K. Study protocol: follow-up home visits with nutrition: a randomised controlled trial. BMC Geriatr. 2011 Dec 28;11:90. doi: 10.1186/1471-2318-11-90.
PubMed 22204420Baldwin C, de van der Schueren MA, Kruizenga HM, Weekes CE. Dietary advice with or without oral nutritional supplements for disease-related malnutrition in adults. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002008. doi: 10.1002/14651858.CD002008.pub5.
PubMed 34931696Beck AM, Kjaer S, Hansen BS, Storm RL, Thal-Jantzen K, Bitz C. Follow-up home visits with registered dietitians have a positive effect on the functional and nutritional status of geriatric medical patients after discharge: a randomized controlled trial. Clin Rehabil. 2013 Jun;27(6):483-93. doi: 10.1177/0269215512469384. Epub 2012 Dec 20.
PubMed 23258932
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Home Visits With Nutrition (OHE)
- ClinicalTrials.gov ID
- NCT01249716
- Acronym / sponsor ID
- OHE / 22
- Conditions
- Malnutrition
- Keywords
- follow-up home visit, Geriatric Disorder, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 Nov 2010 (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.
To assess the effect on geriatric patients of follow-up home visit including nutrition.
The hypothesis is that this can prevent hospital readmissions, and has a positive impact on functional abilities and quality of life
Detailed description
Before and after the intervention the participants nutritional status, hand grip strength, functional abilities, well-being, dietary intake, level of tiredness,and activities of daily living will be assessed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Geriatric patients in nutritional risk
Key exclusion criteria (4 listed)
- Dementia
- Expected readmissions
- Terminal disease
- Non-Danish speaking
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 a registered dietician by means of three follow-up home visits | Dietary supplement | – |
Primary outcome
hospital readmissions
Time frame: one year
1 secondary outcome
body weight
Time frame: 12 weeks
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 29 Mar 2012.
- Background: PubMed 22204420Beck AM, Kjaer S, Hansen BS, Storm RL, Thal-Jantzen K. Study protocol: follow-up home visits with nutrition: a randomised controlled trial. BMC Geriatr. 2011 Dec 28;11:90. doi: 10.1186/1471-2318-11-90.
- Derived from this study: PubMed 34931696Baldwin C, de van der Schueren MA, Kruizenga HM, Weekes CE. Dietary advice with or without oral nutritional supplements for disease-related malnutrition in adults. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002008. doi: 10.1002/14651858.CD002008.pub5.
- Derived from this study: PubMed 23258932Beck AM, Kjaer S, Hansen BS, Storm RL, Thal-Jantzen K, Bitz C. Follow-up home visits with registered dietitians have a positive effect on the functional and nutritional status of geriatric medical patients after discharge: a randomized controlled trial. Clin Rehabil. 2013 Jun;27(6):483-93. doi: 10.1177/0269215512469384. Epub 2012 Dec 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University of Copenhagen 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 4 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 29 Mar 2012. 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?
hospital readmissions (time frame: one year). 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 NCT01249716, 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 29 Mar 2012.