Effect of Nutritional Efforts on Discharged Elderly Patients

Malnutrition Clinical Trial

Official title:

Effect of Nutritional Efforts on Discharged Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488329
• Other study ID #: 2007-58-0015
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: January 2021
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Denmark	Unit for Dietetics and Nutrition Research, Herlev hosipital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital readmissions		6 months
Secondary	Mortality		30 days, 16 weeks, 6 months
Secondary	Weight		16 weeks
Secondary	Protein intake	24 hour recall	16 weeks
Secondary	Energi Intake	24 hour recall	16 weeks
Secondary	Appetite	SNAQ	16 weeks
Secondary	Health related Quality of life	EQ-5D	16 weeks
Secondary	Physical function	30-s CST	16 weeks
Secondary	Hospital readmissions		30 days, 16 weeks
Secondary	Combined adverse advents		30 days, 16 weeks, 6 months