- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519139
Individual Nutritional Intervention for the Prevention of Readmission Among Geriatric Patients
Individual Nutritional Intervention for the Prevention of Readmission Among Geriatric Patients - a Randomized Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Method/Design:
The trial is conducted as a randomized clinical trial, with recruitment of 40 medical geriatric patients (definition: ≥65 years of age with at least two diagnoses, e.g. hypertension, cardiovascular diseases, diabetes, chronic obstructive pulmonary disease, rheumatic diseases or apoplexy). At discharge the test subjects are randomized to receive either individual dietary counseling or standard treatment with follow-up 30 and 60 days after discharge. All data are collected prior to randomization. The intervention consists of three individual dietary counsellings with the aim to ensure sufficient coverage of energy and protein needs of the subjects (the first at the hospital by discharge, then in week 1 and week 3 at the subject's home/the respite care after discharge) and, if necessary, telephone follow-up in weeks 2 and 4 after discharge. The intervention group, if possible, are asked to take photos of all they eat and drink for two days before individual dietary counselling and send the photos electronically to the responsible investigators before the meeting.
Recruitment:
Only admitted patients are included in the trial. Attending physician finds the patients through the Health Platform at Sydsjællands University Hospital. The care staff or the attending physician asks whether the patient is willing to talk with the responsible investigators. The responsible investigators then make personal contact with the geriatric patients while they are hospitalized. Patients will be informed orally and in writing about the trial of the responsible investigators. Patients also receive pamphlets about test subjects rights in a health science research project published by the National Science Ethics Committee with the purpose of giving patients an informed basis to make a decision.
Patients are informed that they can take a family member or friend to the next conversation. Patients receive at least 24 hours of deliberation time, after which they are contacted by the responsible investigators. Patients who wish to participate in the trial are asked to sign a consent statement. This statement is also signed by the responsible investigator who has given the patient oral information about the trial. The subjects are offered a copy of the consent statement. To ensure uninterrupted conversation, conversation will take place in a room without other people or alternatively in the patient's room and a partition will be put of if the patient is not in a room by them self.
Patients who meet the inclusion criteria, wishes to participate in the trial and have signed the consent statement will be contacted again on the date of discharge or the day before, where the trial starts. Test subject may at any time, orally, in writing or by other clear indication, withdraw their consent for participation and withdraw from the trial.
Sample size:
Based on the primary output "readmission/hospitalization of geriatric patients within a month", the sample size is estimated to be at least 20 subjects in the intervention and control groups, respectively. A total of at least 40 subjects.
Statistical analysis:
Hypothesis testing will take place using nonparametric statistical tests, as the data can not be assumed to be normal distribution (Mann-Whitney U and Wilcoxon). Fisher's exact test [M1] is used for analysis of categorical data. Correlations are analyzed using Spermann analysis
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Køge, Denmark, 4600
- Sjaellands Universitetshospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- recruited at Medical Department at Sjælland University Hospital, Køge (sections M1, M2, M6, L1) and discharged to one of following municipalities: Greve, Køge, Roskilde, Solrød and Stevns
- geriatric patients according to the definition
- competent adult and Danish speaking who are able to give written consent
- oral nutrition possible (no tube feeding or intravenous nutrition)
- discharged planned for home or respite care or similar (e.g. family).
Exclusion Criteria:
- diagnosed dementia or under investigation for dementia
- nursing home resident or discharged to nursing homes
- terminal patients
- patients who desire weight loss
- scheduled readmission.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: individual dietary counselling
three individual dietary counsellings.
The first at the hospital by discharge, then in week 1 and week 3 at the subject's home/the respite care after discharge and, if necessary, telephone follow-up in weeks 2 and 4 after discharge
|
individual dietary counsellings with the aim to ensure sufficient coverage of energy and protein needs of the test subjects
|
No Intervention: Control
standard counselling provided by the hospital at discharge.
The standard counselling may include nutritional prescription and nutritional plan, but no follow-up to the nutrition plan after the discharge.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
readmission-or hospitalization rate (%)
Time Frame: 30 days after discharge
|
readmission for the same diagnosis as at discharge.
Hospitalization for a new diagnosis
|
30 days after discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
readmission-/hospitalization rate (%)
Time Frame: 60 days after discharge
|
readmission for the same diagnosis as at discharge.
Hospitalization for a new diagnosis
|
60 days after discharge
|
number of days between readmission or hospitalization and discharge (days)
Time Frame: 30 and 60 days after discharge
|
date minus date
|
30 and 60 days after discharge
|
nutritional status (%)
Time Frame: 30 and 60 days after discharge
|
The proportion of subject who has covered at least 75% of estimated energy and protein needs
|
30 and 60 days after discharge
|
functional status (score, points)
Time Frame: 30 and 60 days after discharge
|
Functional recovery score: P-ADL, I-ADL and mobility
|
30 and 60 days after discharge
|
Quality of Life (score, points)
Time Frame: 30 and 60 days after discharge
|
EQ-5D-5L
|
30 and 60 days after discharge
|
muscle strenght (dyn)
Time Frame: 30 and 60 days after discharge
|
Hand-grip strenght
|
30 and 60 days after discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality (%)
Time Frame: 30 and 60 days after discharge
|
% died from any cause
|
30 and 60 days after discharge
|
side effects in connection with the intervention (number)
Time Frame: 30 and 60 days after discharge
|
any side-effects reported
|
30 and 60 days after discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jens Rikardt Andersen, ass. prof., University of Copenhagen
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-17039329
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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