Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03519139
Other study ID # H-17039329
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2018
Est. completion date June 15, 2018

Study information

Verified date October 2018
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether a four-week individual nutritional intervention can reduce the readmission/hospitalization rate among geriatric patients who are discharged to their private home or respite care. Secondarily, whether an individual nutritional intervention can improve nutritional status, functional status, quality of life, muscle strength and reduce mortality in geriatric patients after discharge Two sub-points are investigated using feasibility studies - if photography documentation of meals can be used in practice to assess the energy and protein intake of geriatric patients and whether photography documentation of the refrigerator content at first home visits in the intervention group can predict whether there is an increased risk of readmission.


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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 15, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
individual dietary counselling
individual dietary counsellings with the aim to ensure sufficient coverage of energy and protein needs of the test subjects

Locations

Country Name City State
Denmark Sjaellands Universitetshospital Køge

Sponsors (1)

Lead Sponsor Collaborator
Jens Rikardt Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other mortality (%) % died from any cause 30 and 60 days after discharge
Other side effects in connection with the intervention (number) any side-effects reported 30 and 60 days after discharge
Primary readmission-or hospitalization rate (%) readmission for the same diagnosis as at discharge. Hospitalization for a new diagnosis 30 days after discharge
Secondary readmission-/hospitalization rate (%) readmission for the same diagnosis as at discharge. Hospitalization for a new diagnosis 60 days after discharge
Secondary number of days between readmission or hospitalization and discharge (days) date minus date 30 and 60 days after discharge
Secondary nutritional status (%) The proportion of subject who has covered at least 75% of estimated energy and protein needs 30 and 60 days after discharge
Secondary functional status (score, points) Functional recovery score: P-ADL, I-ADL and mobility 30 and 60 days after discharge
Secondary Quality of Life (score, points) EQ-5D-5L 30 and 60 days after discharge
Secondary muscle strenght (dyn) Hand-grip strenght 30 and 60 days after discharge
See also
  Status Clinical Trial Phase
Completed NCT04880486 - Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease N/A
Completed NCT05116644 - Prevalence of Factors Contributing to Unplanned Hospital Readmission of Older Medical Patients
Completed NCT04126980 - Early Discharged Lumbar Spine Fusion Reduced Postoperative Readmissions: A Follow-up Study in a National Cohort
Completed NCT04540315 - Reducing Surgical Readmissions Through Mobile Technology N/A
Completed NCT01897870 - The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge. N/A
Completed NCT03053778 - Individualised Follow-up After Valve Surgery N/A
Recruiting NCT04738669 - Mhealth and Teach-Back Effectiveness In 30-Day Readmissions Reduction N/A
Completed NCT05355324 - Risk Factor for Readmission and Death of Lower Respiratory Infections in Older Adults
Active, not recruiting NCT04192175 - Identification of Patients Admitted With COPD Exacerbations and Predicting Readmission Risk Using Machine Learning
Recruiting NCT04480034 - Obesity Surgery During 2020 Italian Pandemic
Completed NCT03116074 - Interactive Digital Health Tools to Improve Patient Safety in Acute Care N/A
Completed NCT02318680 - Follow Home Visits After Discharge N/A
Completed NCT03796923 - Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly N/A
Completed NCT02094040 - Municipality-based Post-discharge Follow-up Visits N/A
Active, not recruiting NCT04071951 - Pharmacist Intervention to Reduce Post-Hospitalization Utilization N/A
Completed NCT05272267 - Transforming ED Throughput With AI-Driven Clinical Decision Support System N/A
Completed NCT06219668 - Comparison of Omentopexy and Clips on the Staple Line During Laparoscopic Sleeve Gastrectomy N/A
Not yet recruiting NCT05798065 - Inpatient Endoscopy Procedure Planning Delays and Impact on Length of Stay and 30-day Readmission