Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation (TELETEST)

Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation of the Elderly

This study concerns elderly person aged more than 65 years with autonomous mobility.

It is a multicentric randomized trial in two arms :

Arm one : remote consultation then physical consultation Arm two : physical consultation then remote consultation

Consultations consist to take a Five Times Sit To Stand test, in physical consultation with physiotherapist in the same room and in remote consultation with a physiotherapist in the next room to the patient.

Study Overview

• Status: Recruiting
• Conditions: Rehabilitation; Teleconsultation; Elderly Person
• Intervention / Treatment: Other: Physical consultation; Other: Teleconsultation

Detailed Description

This study concerns elderly person aged more than 65 years with autonomous mobility.

It is a multicentric randomized trial in two arms :

Arm one : remote consultation then physical consultation Arm two : physical consultation then remote consultation

Consultations consist to take a Five Times Sit To Stand test, in physical consultation with physiotherapist in the same room and in remote consultation with a physiotherapist in the next room to the patient.

Tests are realized at baseline after randomization. The test with best time will be considered for analysis.

Once the 2 tests have been carried out, a satisfaction survey will evaluate the preference between the two tests for each patient.

Patients will be re-contacted by telephone at 3, 6 and 12 months post-inclusion to collect the number of falls.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincent CREAC'H; Phone Number: +33(0)298017935; Email: vincent.creach@univ-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Recruiting
    • Ildys Ty Yann
    • Contact: Solène Bourdonneau; Email: solene.bourdonneau@gmail.com
  • Landerneau, France, 29800
    • Active, not recruiting
    • Institut de réadaptation du Cap Horn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Volunteers over the age of 65.
• Elderly people who can walk and move around independently.
• Subjects capable of giving informed consent.
• GIR 3,4,5,6.
• Affiliated to a Social Security scheme.

Exclusion Criteria:

• GIR < 3
• Major visual and/or hearing impairment (known pathology and not fitted with hearing aids)
• Patient deprived of liberty by judicial or administrative decision, under guardianship or curatorship
• Subject having refused to participate.
• Subject at risk of syncope on rising (cardiac pathologies, orthostatic hypotension).
• Subjects with known vestibular disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Physical consultation followed by Teleconsultation; First, patients take the Five Time Sit To Stand in the presence of the physiotherapist. Then, patients perform the test in a room away from the physiotherapist (there are a computer with a webcam is set up on a desk). There will be a 5-minute rest period between the 2 test conditions (physical consultation and teleconsultation). Each test is performed 2 times. The best time will be retained for analysis.	Other: Physical consultation; The subject enters a room where the therapist is present. A chair is placed against a wall in the same room. Once again, the therapist suggests repeating the test. During the test, the therapist sits opposite the patient, at the same distance as the computer used during the teleconsultation.; Other: Teleconsultation; Prior to the test, the investigator should carry out a "mock" test with a volunteer from the facility, for example, to ensure wifi, sound and image functionality. The patient enters a room where a computer equipped with a webcam is set up on a desk. The teleconsultation has already started when the patient enters the room. No recordings are made. A chair is placed at a distance from the desk, with the backrest against a wall. The chair faces the computer. The desk or table where the computer is located is about 3 meters from the participant, ensuring that the webcam can frame the patient's entire body during the test. With the consultation already underway, the investigator can direct the patient to sit in the chair against the wall. The investigator will make sure that the patient hears the instructions given. Once the patient is seated on the chair, the therapist explains the test procedure and shows it once to make sure the subject understands it.
Other: Teleconsultation followed by physical consultation; First, patients perform the Five Time Sit To Stand in a room away from the physiotherapist (there are a computer with a webcam is set up on a desk). Then, patients take the test in the presence of the physiotherapist. There will be a 5-minute rest period between the 2 test conditions (teleconsultation and physical consultation). Each test is performed 2 times. The best time will be retained for analysis.	Other: Physical consultation; The subject enters a room where the therapist is present. A chair is placed against a wall in the same room. Once again, the therapist suggests repeating the test. During the test, the therapist sits opposite the patient, at the same distance as the computer used during the teleconsultation.; Other: Teleconsultation; Prior to the test, the investigator should carry out a "mock" test with a volunteer from the facility, for example, to ensure wifi, sound and image functionality. The patient enters a room where a computer equipped with a webcam is set up on a desk. The teleconsultation has already started when the patient enters the room. No recordings are made. A chair is placed at a distance from the desk, with the backrest against a wall. The chair faces the computer. The desk or table where the computer is located is about 3 meters from the participant, ensuring that the webcam can frame the patient's entire body during the test. With the consultation already underway, the investigator can direct the patient to sit in the chair against the wall. The investigator will make sure that the patient hears the instructions given. Once the patient is seated on the chair, the therapist explains the test procedure and shows it once to make sure the subject understands it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five Time Sit To Stand test completion time in teleconsultation	The physiotherapist is present in a room at a distance from the patient's consultation room. The Five Time Sit to Stand (FTSS) is a functional assessment that requires a chair and a stopwatch. The patient is timed from start to finish. The time taken to complete the test is expressed in minutes. The patient performs two trials. The best result is retained for analysis.	At inclusion
Five Time Sit To Stand test completion time in face-to-face consultation	The physiotherapist is present in the same consulting room as the patient. The Five Time Sit to Stand (FTSS) is a functional assessment that requires a chair and a stopwatch. The patient is timed from start to finish. The time taken to complete the test is expressed in minutes. The patient performs two trials. The best result is retained for analysis.	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five Time Sit To Stand test completion time in teleconsultation	The physiotherapist is present in a room at a distance from the patient's consultation room. The Five Time Sit to Stand (FTSS) is a functional assessment that requires a chair and a stopwatch. The patient is timed from start to finish. The time taken to complete the test is expressed in minutes. The patient performs two trials. The best result is retained for analysis.	At inclusion
Five Time Sit To Stand test completion time in face-to-face consultation	The physiotherapist is present in the same consulting room as the patient. The Five Time Sit to Stand (FTSS) is a functional assessment that requires a chair and a stopwatch. The patient is timed from start to finish. The time taken to complete the test is expressed in minutes. The patient performs two trials. The best result is retained for analysis.	At inclusion
Satisfaction questionnaire	It is a questionnaire with 4 questions: Question n°1 : 3 answers Question n°2 : bimodal response (Yes /No) Question n°3 : 5 answers Question n°4 : 4 answers Moreover, the therapist completes the following question for each patient: - Do you think this patient could benefit from a follow-up by performing the same test in teleconsultation at home? Yes/No	At inclusion
Presence or absence of falls	Phone call to ask if patient has fallen (Yes/No)	At Month 3, Month 6 and Month 12
Number of falls	Phone calls to ask the number of falls.	At Month 3, Month 6 and Month 12

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 5, 2024
• Last Update Submitted That Met QC Criteria: July 3, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Teleconsultation; Five Time Sit To Stand
• Other Study ID Numbers: 29BRC22.0243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient.
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No