NCT02476110

Brief Summary

Hypothesis : At hospital discharge for home, the medical prescription of ONS according to the official criteria of SSNC and the legal regulations (completed prescription according to health's insurance and homecare delivery) dictates the compliance of the patient and the reimbursement of the ONS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

June 1, 2015

Last Update Submit

January 20, 2017

Conditions

Keywords

Oral nutritive supplementsNutritional risk screeningHomecare

Outcome Measures

Primary Outcomes (1)

  • Oral Nutritive Supplements medical prescription

    Change between prescription at hospital and prescription at hospital discharge (an expected average of 6 days after admission)

Secondary Outcomes (5)

  • NRS 2002 score assessed by questionnaire

    Change between score at oral nutritive supplements prescription at hospital and score at hospital discharge for home (an expected average of 6 days after admission) and score one month after hospital discharge for home

  • Indications for oral nutritive supplements prescription according to the official criteria of SSNC

    At hospital discharge for home (an expected average of 6 days after admission)

  • Number of oral nutritive supplements consumed compared to prescription at hospital discharge

    One month after hospital discharge

  • Timing for stopping the oral nutritive supplements intake if stopped

    One month after hospital discharge

  • Reasons for stopping the oral nutritive supplements intake if stopped

    One month after hospital discharge

Interventions

Oral nutritive supplementsDIETARY_SUPPLEMENT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized adults patients with Oral Nutritive Supplements in medical and surgical wards of the Geneva University Hospital, site of Cluse-Roseraie

You may qualify if:

  • Age \> 18 years
  • Hospitalization in medical and surgical wards of the Geneva University Hospital, site of Cluse-Roseraie
  • Oral nutritive supplements prescription during hospitalization

You may not qualify if:

  • Oral nutritive supplements delivery by a homecare before the admission in Geneva University Hospital wards, site of Cluse-Roseraie
  • Patient refusal to consume oral nutritive supplements
  • Major disorders of consciousness (ex : dementia)
  • Physical impossibility to consume Oral nutritive supplements (ex : dysphagia, dysfunction of upper limbs, etc.)
  • Patient refusal to participate to the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospital

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

  • Mareschal J, Altwegg J, Berthet D, Chikhi M, Chopard P, Graf S, Sierro C, Pichard C, Genton L. Prescription and indication for oral nutritional supplements in a Swiss university hospital: a prospective survey. Swiss Med Wkly. 2017 Aug 3;147:w14475. doi: 10.4414/smw.2017.14475. eCollection 2017.

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Claude Pichard, MD, PhD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition and Head of Clinical Nutrition Unit

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 19, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations