Effect of Nutritional Efforts on Discharged Elderly Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03488329|
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : May 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition||Dietary Supplement: Individual nutritional therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Nutritional Efforts on Discharged Elderly Patients|
|Actual Study Start Date :||May 1, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Individual nutritional therapy
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.
No Intervention: Control
- Hospital readmissions [ Time Frame: 6 months ]
- Mortality [ Time Frame: 30 days, 16 weeks, 6 months ]
- Weight [ Time Frame: 16 weeks ]
- Protein intake [ Time Frame: 16 weeks ]24 hour recall
- Energi Intake [ Time Frame: 16 weeks ]24 hour recall
- Appetite [ Time Frame: 16 weeks ]SNAQ
- Quality of life [ Time Frame: 16 weeks ]EQ-5D
- Physical function [ Time Frame: 16 weeks ]30-s CST
- Hospital readmissions [ Time Frame: 30 days, 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488329
|Contact: Jonas A Svendsen, MSc||38681448 ext firstname.lastname@example.org|
|Contact: Tina Munk, Ph.D.||61160138 ext email@example.com|
|Unit for Dietetics and Nutrition Research, Herlev hosipital||Recruiting|
|Herlev, Denmark, 2730|
|Contact: Tina Munk, PhD 61160138 ext 45 firstname.lastname@example.org|
|Contact: Jonas A Svendsen, MSc 38681448 ext 45 email@example.com|