- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06706661
Implementation of Nutritional Efforts on Discharged Older Patients (KMH2)
Implementation of Nutritional Treatment to Older Patients Discharged With the Liaison Team
The aim of the study is to implement a nutritional treatment when discharging older patients at risk of malnutrition.
Data collected in the study will include an assessment of whether a combination of nutritional treatment and a liaison team reduces the risk of readmissions and mortality, improves nutritional status, physical function and quality of life
Study Overview
Detailed Description
During hospitalization, many older patients are at risk of malnutrition. Malnutrition in older adults is related to reduced physical function, more complications, re-admissions, days in hospital and reduced quality of life. As hospitalizations are often short (approximately 5 days), it is important to focus on nutritional intake during the convalescence period.
Upon discharge, a "Nutrition Gap" often occurs in practice, where the patient does not consume sufficient nutrition to ensure an optimal convalescence period. The lack of nutritional follow-up in connection with the discharge of older patients has been shown to have a markedly negative effect on, among other things, functional ability and readmissions. A study from Herlev Hospital, where the effect of a nutritional treatment upon discharge of older patients was investigated, showed a significant effect on muscle strength, quality of life and nutritional status. Another study from Herlev Hospital has shown that by associating a clinical dietitian with a liaison team and thus focusing on nutrition, the readmission rate was halved.
The problem is that it has not been investigated whether such a cross-sectoral effort can be implemented in practice and the results confirmed.
Hypothesis 1 is that it is possible to include and retain the older patients who are discharged with the liaison team for an effort that includes treatment of the risk of malnutrition and that the older participants find the effort relevant
Hypothesis 2 is that nutritional treatment will be able to reduce the number of unintended readmissions and thereby be cost-effective. Furthermore, it is expected that the nutritional treatment will increase the participants' nutritional status, muscle strength, muscle mass, quality of life and possibly have a positive effect on mortality.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tina Munk, Ph D
- Phone Number: +45 61160138
- Email: tina.munk@regionh.dk
Study Contact Backup
- Name: Anne Marie Beck, Ph.d.
- Phone Number: +45 38682387
Study Locations
-
-
-
Herlev, Denmark, 2730
- Recruiting
- Herlev and Gentofte Hospital
-
Contact:
- Anne Marie Beck, Senior researcher
- Phone Number: +45 38682387
- Email: anne.marie.beck@regionh.dk
-
Contact:
- Tina Munk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Prescription of the Liaison team At nutritional risk according to NRS2002 Age 50+ Can read, hear and understand Danish or English Cognitive able to participate in the study, based on whether they are informed in time, place and own data
Exclusion Criteria:
Receives enteral or parenteral nutrition Following a special diet including texture modified food and drinks Short life expectancy Not deemed eligible by the project staff
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nutritional treament
At the day of discharge the intervention group (IG) receives a package containing foods and drinks covering dietary requirements for the next 24 h.
Further, a goodie-bag containing samples of protein-rich milk-based drinks is provided.
At day 4 after discharge, the IG receives dietetic counselling including a recommendation of daily exercise, and an individual nutrition plan.
Information regarding recommendations of nutritional therapy after discharge is systematically and electronically communicated to the municipality.
The dietician performes telephone follow-ups on day 30 and a home visit at 12 weeks
|
At the day of discharge the intervention group (IG) receives a package containing foods and drinks covering dietary requirements for the next 24 h.
Further, a goodie-bag containing samples of protein-rich milk-based drinks is provided.
At day 4 after discharge, the IG receives dietetic counselling including a recommendation of daily exercise, and an individual nutrition plan.
Information regarding recommendations of nutritional therapy after discharge is systematically and electronically communicated to the municipality.
The dietician performes telephone follow-ups on day 30 and a home visit at 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eligibility
Time Frame: Assessed at baseline
|
Eligibility will be assessed as the number of patients who fulfil the inclusion criteria out of the number of patients discharged with the liaison team
|
Assessed at baseline
|
|
Recruitment
Time Frame: Assessed at baseline
|
Recruitment rate will be assessed as the number of patients recruited out of the number of eligible patients
|
Assessed at baseline
|
|
Retention
Time Frame: Assessed at three months
|
Retention rate will be assessed as the number of patients who complete the nutritional treatment out of the total number of patients recruited
|
Assessed at three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital re-admissions
Time Frame: 30 days, 12 weeks, 6 monts, 1 year and 3 year
|
health care records
|
30 days, 12 weeks, 6 monts, 1 year and 3 year
|
|
Mortality
Time Frame: 30 days, 12 weeks, 6 monts, 1 year and 3 year
|
health care records
|
30 days, 12 weeks, 6 monts, 1 year and 3 year
|
|
Health related Quality of life
Time Frame: 12 weeks
|
Euro-qol tool EQ5D5L
|
12 weeks
|
|
Muscle strenght
Time Frame: 4 days, 30 days, 12 weeks
|
30 seconds chair stand
|
4 days, 30 days, 12 weeks
|
|
Dietary intake
Time Frame: 30 days, 12 weeks
|
24 hours recall
|
30 days, 12 weeks
|
|
weight
Time Frame: 4 days, 30 days
|
body weight measurement
|
4 days, 30 days
|
|
muscle mass
Time Frame: 12 weeks
|
calf circumference
|
12 weeks
|
|
Appetite
Time Frame: 30 days, 12 weeks
|
SNAQ with a score from 5 to 20 where a score at or below 14 can predict weight loss
|
30 days, 12 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Munk T, Svendsen JA, Knudsen AW, Ostergaard TB, Thomsen T, Olesen SS, Rasmussen HH, Beck AM. A multimodal nutritional intervention after discharge improves quality of life and physical function in older patients - a randomized controlled trial. Clin Nutr. 2021 Nov;40(11):5500-5510. doi: 10.1016/j.clnu.2021.09.029. Epub 2021 Sep 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F-24065575
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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