Individual Nutritional Intervention for the Prevention of Readmission Among Geriatric Patients

NCT03519139 | Completed DMC

• 1 other identifier: H-17039329
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Readmission

Keywords

Geriatric patients, nutritional counselling, homevisit

Outcome Measures

Primary Outcomes (1)

• readmission-or hospitalization rate (%)

  readmission for the same diagnosis as at discharge. Hospitalization for a new diagnosis

  30 days after discharge

Secondary Outcomes (6)

• readmission-/hospitalization rate (%)

  60 days after discharge

• number of days between readmission or hospitalization and discharge (days)

  30 and 60 days after discharge

• nutritional status (%)

  30 and 60 days after discharge

• functional status (score, points)

  30 and 60 days after discharge

• Quality of Life (score, points)

  30 and 60 days after discharge

Other Outcomes (2)

• mortality (%)

  30 and 60 days after discharge

• side effects in connection with the intervention (number)

  30 and 60 days after discharge

Study Arms (2)

individual dietary counselling

EXPERIMENTAL

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

Other: individual dietary counselling

Control

NO INTERVENTION

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.

Interventions

individual dietary counselling OTHER

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

individual dietary counselling

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• diagnosed dementia or under investigation for dementia
• nursing home resident or discharged to nursing homes
• terminal patients
• patients who desire weight loss
• scheduled readmission.

Sponsors & Collaborators

• Jens Rikardt Andersen: lead

Study Sites (1)

Sjaellands Universitetshospital

Køge, 4600, Denmark

Location

Related Publications (1)

• Cramon MO, Raben I, Beck AM, Andersen JR. Individual nutritional intervention for prevention of readmission among geriatric patients-a randomized controlled pilot trial. Pilot Feasibility Stud. 2021 Nov 15;7(1):206. doi: 10.1186/s40814-021-00926-9.

  PMID: 34782015 DERIVED

Study Officials

• Jens Rikardt Andersen, ass. prof.

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: May 8, 2018
• Study Start: February 8, 2018
• Primary Completion: May 1, 2018
• Study Completion: June 15, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will be available within one year of study completion
• Access Criteria: Author or co-author from the University of Copenhagen

Locations

DK (1)