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

Cardiac Surgery Clinical Trial

— BECSuP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113565
• Other study ID #: 2016/02
• Status: Completed
• Start date: August 9, 2017
• Est. completion date: June 10, 2018

Study information

• Verified date: May 2019
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: June 10, 2018
• Est. primary completion date: June 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiac Surgery
• Heart Diseases
• Physical Disability
• Surgery--Complications

Intervention

Behavioral:
• Count daily number of footsteps.
Using a connected electronic wristband to mainly quantify daily number of footsteps.

Locations

Country	Name	City	State
France	Cmc Ambroise Pare	Neuilly-sur-Seine	ILE DE France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

References & Publications (5)

Ball L, Costantino F, Pelosi P. Postoperative complications of patients undergoing cardiac surgery. Curr Opin Crit Care. 2016 Aug;22(4):386-92. doi: 10.1097/MCC.0000000000000319. Review. — View Citation

Hulzebos EH, Smit Y, Helders PP, van Meeteren NL. Preoperative physical therapy for elective cardiac surgery patients. Cochrane Database Syst Rev. 2012 Nov 14;11:CD010118. doi: 10.1002/14651858.CD010118.pub2. Review. — View Citation

Kim DH, Kim CA, Placide S, Lipsitz LA, Marcantonio ER. Preoperative Frailty Assessment and Outcomes at 6 Months or Later in Older Adults Undergoing Cardiac Surgical Procedures: A Systematic Review. Ann Intern Med. 2016 Nov 1;165(9):650-660. doi: 10.7326/M — View Citation

Mainini C, Rebelo PF, Bardelli R, Kopliku B, Tenconi S, Costi S, Tedeschi C, Fugazzaro S. Perioperative physical exercise interventions for patients undergoing lung cancer surgery: What is the evidence? SAGE Open Med. 2016 Oct 19;4:2050312116673855. eColl — View Citation

Mazzeffi M, Zivot J, Buchman T, Halkos M. In-hospital mortality after cardiac surgery: patient characteristics, timing, and association with postoperative length of intensive care unit and hospital stay. Ann Thorac Surg. 2014 Apr;97(4):1220-5. doi: 10.101 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the resumption of physical activity after cardiac surgery by counting the number of daily footsteps.	Count the number of daily footsteps	2 months