Effect of Nutritional Efforts on Discharged Elderly Patients

NCT ID: NCT03488329

Last Updated: 2021-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention

Intervention group

Individual nutritional therapy

Group Type EXPERIMENTAL

Individual nutritional therapy

Intervention Type DIETARY_SUPPLEMENT

Guidance from a clinical dietician.

Individual nutrition plan

A package containing foods and drinks, which will cover their nutritional needs the first day after discharge.

A goodiebag containing samples on protein-rich milk-based drinks.

Telephone follow-up after 4 and 30 days and the possibility to call the dietician in case of questions about nutrition.

Control

Control group

Standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Individual nutritional therapy

Guidance from a clinical dietician.

Individual nutrition plan

A package containing foods and drinks, which will cover their nutritional needs the first day after discharge.

A goodiebag containing samples on protein-rich milk-based drinks.

Telephone follow-up after 4 and 30 days and the possibility to call the dietician in case of questions about nutrition.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jonas Anias Svendsen

Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Unit for Dietetics and Nutrition Research, Herlev hosipital

Herlev, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34656032 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32345358 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007-58-0015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.