Back to resultsNutritional Intervention in Geriatric Patients
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional intervention programme
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition focused on measuring Geriatrics, Nutritional risk, Multi-disciplinary intervention, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- Age 65 or above
- BMI <20.5 and/or weight loss within the last 3 months and/or a reduced dietary intake in the previous week and/or severely ill
Exclusion Criteria:
- Terminal illness
- Active cancer diagnosis
- Permanently living in a nursing home
- Not willing or able to give an informed consent.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutritional intervention programme
Usual care
Arm Description
An individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).
Usual care which means no individual dietary plan and no nutrition follow-up visits after discharge.
Outcomes
Primary Outcome Measures
Nutritional status
Change in body weight (kg)
Secondary Outcome Measures
Functional status
Barthel Index (scale 0-100)
Functional status
Handgrip strength (kg)
Self-rated health
Self-rated health was measured with one single question with 5 possible responses on a Likert scale: In general, how would you rate your Health?
Re-admission
All-cause unplanned readmissions
Mortality
All-cause mortality
Full Information
NCT ID
NCT03131856
First Posted
March 31, 2017
Last Updated
April 24, 2017
Sponsor
University Hospital, Gentofte, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT03131856
Brief Title
Nutritional Intervention in Geriatric Patients
Official Title
A Multidisciplinary Nutritional Intervention Programme Across Sectors to Improve the Nutritional Status of Geriatric Patients at Nutritional Risk - A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 15, 2012 (Actual)
Primary Completion Date
August 17, 2015 (Actual)
Study Completion Date
December 31, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to investigate the effect of a multi-disciplinary nutritional intervention program in geriatric nutritional at risk patients. The study is carried out as randomized controlled trial. The intervention consists of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Geriatrics, Nutritional risk, Multi-disciplinary intervention, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible patients were randomized to either the intervention group or control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional intervention programme
Arm Type
Experimental
Arm Description
An individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks).
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care which means no individual dietary plan and no nutrition follow-up visits after discharge.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional intervention programme
Intervention Description
The intervention consisted of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks) conducted by a district nurse.
Primary Outcome Measure Information:
Title
Nutritional status
Description
Change in body weight (kg)
Time Frame
Three months follow-up
Secondary Outcome Measure Information:
Title
Functional status
Description
Barthel Index (scale 0-100)
Time Frame
Three months follow-up
Title
Functional status
Description
Handgrip strength (kg)
Time Frame
Three months follow-up
Title
Self-rated health
Description
Self-rated health was measured with one single question with 5 possible responses on a Likert scale: In general, how would you rate your Health?
Time Frame
Three months follow-up
Title
Re-admission
Description
All-cause unplanned readmissions
Time Frame
Up to three months
Title
Mortality
Description
All-cause mortality
Time Frame
1) Up to 90 days after discharge 2) Up to 120 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 65 or above
BMI <20.5 and/or weight loss within the last 3 months and/or a reduced dietary intake in the previous week and/or severely ill
Exclusion Criteria:
Terminal illness
Active cancer diagnosis
Permanently living in a nursing home
Not willing or able to give an informed consent.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nutritional Intervention in Geriatric Patients
We'll reach out to this number within 24 hrs