Clinical trial NCT03488329: Effect of Nutritional Efforts on Discharged Elderly Patients
Official title: Effect of Nutritional Efforts on Discharged Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Hospital readmissions
Seniors
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 207
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is a randomized controlled study, ongoing over 16 weeks. At discharge, the intervention group receives guidance from a clinical dietician, where an individual nutrition plan is made. The dietitian will perform a telephone follow-up after 4 and 30 days. It will also be possible for the participant, relatives or municipality to contact the dietician if nutritional questions arise.

At the time of discharge the intervention group will receive a package containing foods and drinks that will cover their nutritional needs the first day after discharge.

They will also get a goodiebag containing samples on protein-rich milk-based drinks. Data is collected on quality of life, appetite, physical function, dietary intake, weight, height, energy and protein needs, as well as experience of discharge and cooperation with the municipality.

If there is a need, information about nutrition status will be sent to the municipality so the municipality can take over nutritional treatment.

The control group receives standard treatment.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to Oncology, Gastro-medical / Surgical, and Medical Department, HGH, Herlev.
* Age: 50+
* At admission, found in nutritional risk score ≥3 according to NRS-2002.
* On special food concept, Herlev's Glories during hospitalization
* Discharged to own home in a municipality in Planområde Midt (Ballerup, Herlev, Lyngby-Tårbæk, Gentofte, Gladsaxe, Rødovre, Egedal, Rudersdal, Furesø).
* Can read, hear and understand Danish
* Cognitive able to participate in the study, based on whether they are informed in time, place and own data.

Exclusion Criteria:

* Food allergy or intolerance
* Planned weight loss or following a special diet
* Receives enteral or parenteral nutrition
* Patients with moderate to severe dysphagia, defined with a need for gratin or a creamy diet
* Patients who does not want a food package or goodiebag
* Patients who are permanently bedridden
* Patients who are discharged to nursing homes or rehabilitation
* Patients in isolation
* Late palliative patients
* Terminal patients

Primary outcomes:
measure: Hospital readmissions
timeFrame: 6 months
Secondary outcomes:
measure: Mortality
timeFrame: 30 days, 16 weeks, 6 months
measure: Weight
timeFrame: 16 weeks
measure: Protein intake
timeFrame: 16 weeks
measure: Energi Intake
timeFrame: 16 weeks
measure: Appetite
timeFrame: 16 weeks
measure: Health related Quality of life
timeFrame: 16 weeks
measure: Physical function
timeFrame: 16 weeks
measure: Hospital readmissions
timeFrame: 30 days, 16 weeks
measure: Combined adverse advents
timeFrame: 30 days, 16 weeks, 6 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Unit for Dietetics and Nutrition Research, Herlev hosipital
Study officials:
References:
citation: 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.
citation: Munk T, Svendsen JA, Knudsen AW, Ostergaard TB, Beck AM. Effect of nutritional interventions on discharged older patients: study protocol for a randomized controlled trial. Trials. 2020 Apr 28;21(1):365. doi: 10.1186/s13063-020-04301-6.