Postbariatric EArly Discharge Controlled by Healthdot

NCT ID: NCT04754893

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2021-12-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Healthdot application

Intervention Type: DEVICE

Healthdot device is applied on subject's chest after surgery

Group b

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Healthdot application

Healthdot device is applied on subject's chest after surgery

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Electronics Nederland B.V. acting through Philips CTO organization

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Nienhuijs

Role: PRINCIPAL_INVESTIGATOR

Catharina Hospital, Eindhoven, The Netherlands

Locations

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 37415024 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35063007 (View on PubMed)

Other Identifiers

ICBE-2-36455

Identifier Type: -

Identifier Source: org_study_id