NCT04464278

Brief Summary

The aim of this study is to correlate weight variation as well as body composition with mortality and unscheduled readmission of geriatric population

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 8, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

June 8, 2020

Last Update Submit

July 8, 2020

Conditions

Body Weight Changes

Keywords

GeriatricSuite Care and RehabilitationBody composition

Outcome Measures

Primary Outcomes (2)

  • The prognosis value of variation of weight on mortality

    Determination of variation of weight between D0 and D21 after inclusion

    3 months

  • Mortality rate

    Monitoring of survival at 3 months after inclusion

    3 months

Secondary Outcomes (5)

  • The pprognosis value of variation of weight on unscheduled readmission in SSR

    Between D0 and D21

  • Unscheduled readmission in SSR

    during 15 days after the end of hospitalization

  • Lean mass pronostic value

    3 months after the inclusion

  • In fat mass pronostic value

    3 months after the inclusion

  • fat / lean mass ratio

    3 months after the inclusion

Study Arms (2)

Case group: weight loss ≥ 5%

Control group: weight loss ≤ 5%

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Geriatric population hospitalized in geriatric department at Rothschild and Emile-Roux hospitals

You may qualify if:

  • Patient ≥70 years old
  • Hospitalized in SSR for less than 7 days
  • No patient opposition

You may not qualify if:

  • patient with a pacemaker
  • lake of nutritional assessment on admission
  • lake of assessment of autonomy at admission
  • Patient under guardianship or curatorship
  • Patient participating in another clinical research
  • Patient for whom a short stay (\<21 days) is planned in SSR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christine FORASASSI, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine FORASASSI, MD

CONTACT

01 40 19 34 14christine.forasassi@aphp.fr

Christian AUSSEL, MD

CONTACT

01 40 19 34 00christian.aussel@aphp.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2020

First Posted

July 9, 2020

Study Start

July 1, 2020

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

July 9, 2020

Record last verified: 2020-07