Connected Electronic Wrist Strap for Patient Follow-up After Cardiac Surgery

Completed

• Conditions: Cardiac Surgery; Surgery--Complications; Cardiac Disease; Physical Disability

• Registration Number: NCT03113565
• Lead Sponsor: CMC Ambroise Paré

Brief Summary

After cardiac surgery, patients' follow-up after discharge is a major public health issue. Since the main complications occur mostly during the first extra-hospital month, a follow-up period becomes necessary as the average duration of hospitalization tends to decrease. The resumption of normal physical activity is rarely transmitted and when complications arise, the healthcare team is most often informed late.

An electronic wristband is worn by the patient during the day, between the day of discharge from the hospital (D0) and the end of the second extra-hospital month (D60). The data recorded by the wristband include : bracelet ID, date, time and number of steps per day.

The primary objective of the study is to measure the resumption of physical activity after elective cardiac surgery. This objective will be quantified by the number of daily footsteps.

A secondary objective is to determine perioperative predictors of the physical resumption.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-13
• Study Start: 2017-08-09
• Primary Completion: 2018-06-10
• Study Completion: 2018-06-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Adult patients who underwent elective cardiac surgery, regardless of indication and type of intervention.

Exclusion Criteria

• Refuse of the patient,
• Misunderstanding of the system (electronic wristband, application) or the principle of the study (language problem, cerebral vascular sequelae),
• Pre-existing handicap that does not allow walking (not related to the cardiac pathology leading to the planned cardiac surgery).
• Patients who are unable to understand the content of the information delivered
• Pregnant women can not be included in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure the resumption of physical activity after cardiac surgery by counting the number of daily footsteps.	2 months	Count the number of daily footsteps

Trial Locations

Locations (1)

Cmc Ambroise Pare; 🇫🇷 Neuilly-sur-Seine, ILE DE France, France