NCT04170218

Brief Summary

Introduction: Hip and knee osteoarthritis (OA) was ranked in 2010 as the eleventh highest contributor to global disability. In France in 2014, non-spinal OA was the leading self-reported cause of morbidity among adults over sixty-five years of age, with a prevalence of 49.5 per cent. OA is known to be the first cause of disability in activities of daily life and a risk factor of frailty among people over seventy-five years of age. Despite its major impact on the elderly population's quality of life and health, quality of care for OA in elderly patients remains understudied. Objective: The study aims to assess the quality of care for knee and hip OA in patients aged 75 years and over.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
405

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

October 25, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 20, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 25, 2019

Last Update Submit

November 19, 2019

Conditions

Keywords

knee osteoarthritiship osteoarthritisquality of healthcareelderly

Outcome Measures

Primary Outcomes (1)

  • number of participants referred to an orthopedic surgeon as assessed by ACOVE's quality indicator questionnaire

    at enrollment

Secondary Outcomes (18)

  • rate of eligible patients who passed the quality indicator about annual assessment of functional status and degree of pain, assessed by questionnaire

    at enrollment

  • rate of eligible patients who passed the quality indicator about exercise therapy for patients with newly diagnosed knee osteoarthritis, assessed by questionnaire

    at enrollment

  • rate of eligible patients who passed the quality indicator about education regarding the natural history, treatment, and self- management of osteoarthritis, assessed by questionnaire

    at enrollment

  • rate of eligible patients who passed the quality indicator about acetaminophen as first-line pharmacologic therapy, assessed by questionnaire

    at enrollment

  • rate of eligible patients who passed the quality indicator about advising patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) of their risks, assessed by questionnaire

    at enrollment

  • +13 more secondary outcomes

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients hospitalized in seven geriatric departments of three hospitals of "Assistance Publique - Hôpitaux de Paris", for any cause of admission

You may qualify if:

  • patients aged seventy-five years or over
  • with symptomatic hip or knee osteoarthritis according to the American College of Rheumatology criteria
  • with pain for more than three months
  • affiliated to French social security
  • having given their oral non-opposition to participate (or oral non-opposition of the guardian in case of legal guardianship)

You may not qualify if:

  • clinical or radiological sign suggesting a differential diagnosis for hip or knee pain
  • acute disease with clinical repercussion on walking
  • life-threatened patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, 94010, France

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jean-Philippe David, PhD

    STUDY DIRECTOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 25, 2019

First Posted

November 20, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

November 20, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Locations