Postbariatric EArly Discharge Controlled by Healthdot (PEACH)

Postbariatric EArly Discharge Controlled by Healthdot (PEACH)

This clinical investigation is a single center patient preference trial in a tertiary hospital in the Netherlands, designed to compare the outcome of two different recovery paths after standard of care bariatric surgery. The difference between both recovery paths is that half of the patients will get the standard of care by staying one night in the hospital before returning home (group B), while the other half will receive a Healthdot directly after surgery and leave the hospital on the same day (evening) (group A). 200 patients will be recruited and can choose whether they want to be assigned to the the regular recovery path or receive a Healthdot and leave the hospital on the same day. If they have no preference they will be randomly assigned to one of the two groups. Patients in the outpatient recovery group will wear the Healthdot for 7 days at home and vital signs (heart rate and respiratory rate, together with context data on activity and posture) will be transmitted to the hospital to monitor recovery. The study is mainly designed to investigate if the clinical outcome in both groups is equal (non-inferiority) based on a combined outcome measures like 30 days readmission rate and patient satisfaction.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Device: Healthdot application

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
      • Catharina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult (equal or above 18)
• Approval for primary bariatric surgery (gastric sleeve or bypass) by a multidisciplinary bariatric team
• Willing and able to sign informed consent form
• Able to understand instructions
• In possession of a telephone on which patient can be reached for the duration of participation (day 1-8)
• An adult person must be present at the same location as the patient during the first night following surgery who is able to mobilize help or seek medical care if necessary.

Exclusion Criteria:

• Patients of psychiatric wards, inmates of prisons, or other state institutions
• Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
• Any skin condition, for example prior rash, discoloration, scars or open wounds at the area (Left lower rib) where the Healthdot needs to be placed
• Known allergy for the tissue adhesive used in the Healthdot (white band-aid)
• Use of topical that is known to influence the skin at the test area (such as medical and non-medical creams or lotions)
• Patient with active implantables such as Implantable Cardioverter Defibrilator (ICD) and pacemaker
• Expected participation less than 8 days
• Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
• Patients with antibiotic resitant infections (e.g. MRSA)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Healthdot directly after surgery and leave the hospital on the same day (evening) (group A)	Device: Healthdot application; Healthdot device is applied on subject's chest after surgery
No Intervention: Group b; Standard of care by staying one night in the hospital before returning home (group B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality will be determined from the patient medical record	Within 30 days after primary surgery
Severe postoperative complications (Clavien-Dindo IIIb or higher)	Severe postoperative complications will be determined from the patient medical record	Within 30 days after primary surgery
Readmission (at least one night in hospital)	Readmission will be determined from the patient medical record	Within 30 days after primary surgery
Mild complications (Clavien-Dindo II and IIIa)	Mild complications will be determined from the patient medical record	Within 30 days after primary surgery
Prolonged length of stay (3 days or more in hospital)	Prolonged length of stay will be determined from the patient medical record	Within 30 days after primary surgery

Collaborators and Investigators

• Sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
• Investigators: Principal Investigator: Simon Nienhuijs, Catharina Hospital, Eindhoven, the Netherlands

Publications and helpful links

General Publications

• Scheerhoorn J, van Ede L, Luyer MDP, Buise MP, Bouwman RA, Nienhuijs SW. Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial. Trials. 2022 Jan 21;23(1):67. doi: 10.1186/s13063-022-06001-9.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): December 25, 2021
• Study Completion (Actual): December 25, 2021

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ICBE-2-36455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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