Postbariatric EArly Discharge Controlled by Healthdot

NCT04754893 | Completed

• 1 other identifier: ICBE-2-36455
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Healthdot directly after surgery and leave the hospital on the same day (evening) (group A)

Device: Healthdot application

Group b

NO INTERVENTION

Standard of care by staying one night in the hospital before returning home (group B)

Interventions

Healthdot application DEVICE

Healthdot device is applied on subject's chest after surgery

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philips Electronics Nederland B.V. acting through Philips CTO organization: lead

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (2)

• van Ede ES, Scheerhoorn J, Schonck FMJF, van der Stam JA, Buise MP, Nienhuijs SW, Bouwman RA. Lessons Learned from Telemonitoring in an Outpatient Bariatric Surgery Pathway-Secondary Outcomes of a Patient Preference Clinical Trial. Obes Surg. 2023 Sep;33(9):2725-2733. doi: 10.1007/s11695-023-06637-9. Epub 2023 Jul 7.

  PMID: 37415024 DERIVED

• 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.

  PMID: 35063007 DERIVED

Study Officials

• Simon Nienhuijs

  Catharina Hospital, Eindhoven, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 15, 2021
• Study Start: February 22, 2021
• Primary Completion: December 25, 2021
• Study Completion: December 25, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)