Under NutritionNCT01345032
The Effect of Nutrition Follow up After Hospital Discharge in Undernourished Elderly
A study testing Home visit and Telephone consultation in people with Under Nutrition, run by Aarhus University Hospital at 2 sites in Denmark.
Trial summary
The purpose of this study is to test two different interventions of nutrition follow up after discharge from geriatric ward in undernourished geriatric patients. The patients are randomized to a home visit arm, a telephone consultation arm, or a control arm. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Under Nutrition
- What is being tested?
- Home visit and Telephone consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2011to Dec 2015
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged 75 and over
- undernourished according to Mini Nutritional Assessment (MNA)
- living alone in own home
- admitted and discharged from geriatric ward Aarhus, Denmark, due to various acute somatic disorders
Who cannot join
- active cancer
- mental disorder (MMSE<22)
- live together with another person
- live in a nursing home
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus Universityhospital, Geriatric Department
Aarhus, 8000
Geriatric Department
Aarhus, 8000
About this study
Official title: The Effect of Follow up on Nutrition Intervention After Discharge in Undernourished Geriatric Patients
The purpose of this study is to test two different interventions of nutrition follow up after discharge from geriatric ward in undernourished geriatric patients. The patients are randomized to a home visit arm, a telephone consultation arm, or a control arm. Patients in the home visit arm and their home care helper will get visits from a clinical dietician at one week, two weeks and four weeks after discharge, in order to follow up on the nutrition intervention. Patients in the telephone consultation arm and their home care helper will be contacted by a clinical dietician at one week, two weeks and four weeks after discharge, in order to follow up on the nutrition intervention. The control arm will not be contacted.
The primarily outcome is functional ability. Secondary outcomes are quality of life, readmission and mortality.
Read the detailed description
Under nutrition among geriatric patients is a recurrent and well documented problem. Up to 55 % of the elderly are undernourished at the time of admission. Hospitalisation and acute illness are associated to loss of muscles and physical ability, complications, dependency, morbidity and mortality. Elderly who live alone are more vulnerable to nutritional problems, than elderly who live together with another person or in a nursing home. Geriatric patients, who are admitted to geriatric ward Aarhus University Hospital due to various acute somatic disorders, aged 75 and older and who are living alone with help from the home care facilities can participate in the study. According to the power calculation 150 patients must be included, 50 patients in each arm of the study. Informed consent will be obtained before inclusion and discharge from hospital. Randomization will be computerised and determine if the patient will be allocated to the "home visit" group, the "telephone consultation" group or the "control group". Patients who suffer from mental disorder (MMSE<22) or active cancer are excluded as well as patients who live together with another person or live in a nursing home. During hospitalisation the three groups will receive the same nutritional care as all patients in nutritional risk. This includes nutritional intervention during hospitalization and an individual diet plan at discharge. Patients in the home visit arm will get visits from a clinical dietician at one week, two weeks and four weeks after discharge. Patients in the telephone consultation arm will be contacted by a clinical dietician at one week, two weeks and four weeks after discharge. In both intervention groups the patients and their home care helpers will get dietary advice and follow up on their individual diet plan. The main outcome is functional ability from discharge and to 8 weeks after discharge. Secondary outcomes are quality of life, readmission at 30 and 90 days and mortality at 30 and 90 days.
- Conditions
- Under Nutrition
- Being tested
- Home visit, Telephone consultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitOther
Also called Aged 75 and over, Living alone, Receive help for home care services, Dietary advice after discharge by home visits
Patients and their homecare helper will receive visits from a clinical dietician 1 week, 2 weeks and 4 weeks after discharge. The purpose of the visits is follow up on the individual diet plan distributed at discharge and supply dietary advice.
Telephone consultationOther
Also called Aged 75 and over, Living alone, Receive help for home care services, Dietary advice after discharge by telephone consultation
Patients and their homecare helper will be contacted on telephone from a clinical dietician 1 week, 2 weeks and 4 weeks after discharge. The purpose of the telephone contact is follow up on the individual diet plan distributed at discharge and supply dietary advice.
| Study group | Role | What they receive |
|---|---|---|
| Home visits | Experimental | Nutritional follow-up after discharge, conducted as nutritional counselling performed as in-person counselling in the participants homes Receives: Other: Home visit |
| Telephone consultation | Experimental | Nutritional follow-up after discharge, conducted as nutritional counselling performed as telephone consultation Receives: Other: Telephone consultation |
| Control | No intervention | No follow-up after discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional ability.
Measurements: Barthel-100 Index, Cumulated Ambulation Score (CAS), handgrip strength, part of senior fitness test,fatigue test (Avlund)
Measured: Between discharge and 8 weeks after discharge
Secondary outcomes (5)
Quality of Life
Measurements: SF-36, geriatric depression score (GDS), depression list (DL)
Measured: Between discharge and 8 weeks after discharge
Mortality
Measured: Between discharge and 30 after discharge
Readmission to hospital
Measured: Between discharge and 30 days after discharge
Readmission
Measured: Between discharge and 90 days after discharge
Mortality
Measured: Between discharge and 90 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Under NutritionStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jette Lindegaard Pedersen, Aarhus University Hospital
- Investigators
- Jette Lindegaard Pedersen, MHSc., Principal investigator, Aarhus University HospitalElse Marie S. Damsgaard, Professor, Study chair, Aarhus University HospitalPreben Ulrich Pedersen, Ph.D., Study chair, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345032
- Sponsor's protocol ID
- 23012011
- Status last verified
- Dec 2015
- First submitted
- 28 Apr 2011
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Follow up on Nutrition Intervention After Discharge in Undernourished Geriatric Patients
- ClinicalTrials.gov ID
- NCT01345032
- Acronym / sponsor ID
- 23012011
- Conditions
- Under Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Apr 2011 (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 purpose of this study is to test two different interventions of nutrition follow up after discharge from geriatric ward in undernourished geriatric patients. The patients are randomized to a home visit arm, a telephone consultation arm, or a control arm. Patients in the home visit arm and their home care helper will get visits from a clinical dietician at one week, two weeks and four weeks after discharge, in order to follow up on the nutrition intervention. Patients in the telephone consultation arm and their home care helper will be contacted by a clinical dietician at one week, two weeks and four weeks after discharge, in order to follow up on the nutrition intervention. The control arm will not be contacted.
The primarily outcome is functional ability. Secondary outcomes are quality of life, readmission and mortality.
Detailed description
Under nutrition among geriatric patients is a recurrent and well documented problem. Up to 55 % of the elderly are undernourished at the time of admission. Hospitalisation and acute illness are associated to loss of muscles and physical ability, complications, dependency, morbidity and mortality. Elderly who live alone are more vulnerable to nutritional problems, than elderly who live together with another person or in a nursing home. Geriatric patients, who are admitted to geriatric ward Aarhus University Hospital due to various acute somatic disorders, aged 75 and older and who are living alone with help from the home care facilities can participate in the study. According to the power calculation 150 patients must be included, 50 patients in each arm of the study. Informed consent will be obtained before inclusion and discharge from hospital. Randomization will be computerised and determine if the patient will be allocated to the "home visit" group, the "telephone consultation" group or the "control group". Patients who suffer from mental disorder (MMSE<22) or active cancer are excluded as well as patients who live together with another person or live in a nursing home. During hospitalisation the three groups will receive the same nutritional care as all patients in nutritional risk. This includes nutritional intervention during hospitalization and an individual diet plan at discharge. Patients in the home visit arm will get visits from a clinical dietician at one week, two weeks and four weeks after discharge. Patients in the telephone consultation arm will be contacted by a clinical dietician at one week, two weeks and four weeks after discharge. In both intervention groups the patients and their home care helpers will get dietary advice and follow up on their individual diet plan. The main outcome is functional ability from discharge and to 8 weeks after discharge. Secondary outcomes are quality of life, readmission at 30 and 90 days and mortality at 30 and 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home visits | Experimental | Other: Home visitNutritional follow-up after discharge, conducted as nutritional counselling performed as in-person counselling in the participants homes |
| Telephone consultation | Experimental | Other: Telephone consultationNutritional follow-up after discharge, conducted as nutritional counselling performed as telephone consultation |
| Control | No intervention | –No follow-up after discharge |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- aged 75 and over
- undernourished according to Mini Nutritional Assessment (MNA)
- living alone in own home
- admitted and discharged from geriatric ward Aarhus, Denmark, due to various acute somatic disorders
Key exclusion criteria (4 listed)
- active cancer
- mental disorder (MMSE<22)
- live together with another person
- live in a nursing home
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 |
|---|---|---|
| Home visitAlso: Aged 75 and over, Living alone, Receive help for home care services, Dietary advice after discharge by home visitsPatients and their homecare helper will receive visits from a clinical dietician 1 week, 2 weeks and 4 weeks after discharge. The purpose of the visits is follow up on the individual diet plan distributed at discharge and supply dietary advice. | Other | Home visits |
| Telephone consultationAlso: Aged 75 and over, Living alone, Receive help for home care services, Dietary advice after discharge by telephone consultationPatients and their homecare helper will be contacted on telephone from a clinical dietician 1 week, 2 weeks and 4 weeks after discharge. The purpose of the telephone contact is follow up on the individual diet plan distributed at discharge and supply dietary advice. | Other | Telephone consultation |
Primary outcome
Functional ability.
Time frame: Between discharge and 8 weeks after discharge
Measurements: Barthel-100 Index, Cumulated Ambulation Score (CAS), handgrip strength, part of senior fitness test,fatigue test (Avlund)
5 secondary outcomes
Quality of Life
Time frame: Between discharge and 8 weeks after discharge
Mortality
Time frame: Between discharge and 30 after discharge
Readmission to hospital
Time frame: Between discharge and 30 days after discharge
Readmission
Time frame: Between discharge and 90 days after discharge
Mortality
Time frame: Between discharge and 90 days after discharge
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 31 Dec 2015.
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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.
Jette Lindegaard Pedersen, MHSc. principal investigator
Aarhus University Hospital
Else Marie S. Damsgaard, Professor study chair
Aarhus University Hospital
Preben Ulrich Pedersen, Ph.D. study chair
University of Aarhus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visit and Telephone consultation in people with Under Nutrition, run by Aarhus University Hospital at 2 sites 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 4 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 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Functional ability. (time frame: Between discharge and 8 weeks after discharge). 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 31 Dec 2015.