NCT05852821

Brief Summary

The purpose of this clinical study is to determine if a learning effect exists when the 5STS is assessed remotely via videoconference in patients with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

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

April 18, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

April 27, 2023

Last Update Submit

January 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • the variation in time of 5STS between first assay and fifth assay during the first visit (V1).

    1 day

Secondary Outcomes (8)

  • the variation in time of 5STS between each trial at the first visit (V1).

    1 day

  • the variation in time of 5STS between the first visit (V1) and the second visit (V2).

    2 days

  • the variation in time of 5STS between the second visit (V2) and the third visit (V3).

    1 month

  • The reproducibility of the remote test

    1 month

  • The number of tests not carried out

    through study completion, an average of 1 year

  • +3 more secondary outcomes

Study Arms (1)

remote 5STS through videoconference

EXPERIMENTAL
Other: 5STS remote assessment via videoconference

Interventions

Patients will be asked to perform several times the 5STS test, from their home through videoconference, on 3 occasions (day 1, 24h later and 1month later).

remote 5STS through videoconference

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Obtaining oral informed consent after a minimum reflection period of 24 hours
  • Patient with internet access at home and a tool allowing the realization of a videoconference (smartphone or computer)

You may not qualify if:

  • Patients who had a recent exacerbation (less than 4 weeks)
  • Patients physically unable to get up from a chair and sit down without help
  • Patients with significant and unstable cardiovascular disease
  • Any acute or chronic pathology (orthopedic, neurological, psychiatric or causing a major cognitive disorder) limiting the performance of a functional test
  • Inability or difficulty using digital tools
  • Adults protected by law or patient under guardianship or curatorship
  • Subjects deprived of liberty by a judicial or administrative decision
  • Current or planned pregnancy during the study period
  • Pregnant or breastfeeding women
  • Patients not affiliated to a French social security scheme or not benefiting from such a scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique du Souffle la Vallonie

Lodève, 34700, France

Location

Study Officials

  • Nelly HERAUD

    Director of research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 10, 2023

Study Start

April 18, 2023

Primary Completion

January 4, 2024

Study Completion

January 4, 2024

Last Updated

January 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations