Digital Preparation for Bariatric Surgery: Feasability Pilot Trial

NCT ID: NCT07201870

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1050 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2028-10-01

Brief Summary

Metabolic and bariatric surgery (MBS) is in increasing demand due to the growing prevalence of severe obesity and the cumulating evidence of long-term benefits on weight loss, cardiometabolic and functional health outcomes, and quality of life for individuals living with severe obesity. The time spent on the waiting list for an MBS follow the same trend with an estimated waiting time of more than 18 months and rising. The lack of resources and multidisciplinary capabilities among MBS centers impacts the quality of care and outcomes, which greatly contributes to delayed surgery. In 2023, 31% of patients who had an initial appointment with the MBS nurse at the Quebec Heart and Lung Institute - Laval University(IUCPQ) did not proceed with the surgery due to fear, uncertainty, or timing issues. Additionally, 49% reported that their concerns (e.g., financial, home support) were not addressed before MBS. These data highlight the urgent need to implement strategies to optimize wait time and ensure that MBS preparation is tailored to patients' expectations. Telehealth has significantly impacted surgical preparation, including for MBS, by enhancing accessibility, reducing dropout rates, and maintaining clinical outcomes that are comparable to traditional in-person visits but it requires real-time multidisciplinary execution, limiting the applicability for MBS waiting list patients. An interesting complement to telehealth intervention is online education platforms which offer digital flexibility, a significant advantage over in-person session.

To date, most MBS online resources are fee-based or driven by commercial interests and lack of clinical evidence, which raises concerns about their efficacy and safety for users who are seeking reliable support during their MBS journey.

A free online education platform could optimize the time spent on the MBS waiting list by increasing patients' readiness for MBS, furnishing invaluable insights into the patient journey to MBS, and empowering individuals undergoing MBS. The IUCPQ is in the process of working on the care trajectory of patients with obesity. The Healthcare Direction and the Bariatric Surgery Clinic decided to use a platform called Precare. This platform offers personalized educational content as well as a calendar and appointment management system. It has been accredited by the Quebec Ministry of Health and Social Services. The present research focuses on the pilot testing the implementation and effectiveness of the PreCare solution for patients awaiting bariatric surgery at the IUCPQ.

The objectives of the research proposal are: 1) To assess the usability and acceptability of the Precare platform using a mixed design methodology; 2) To evaluate the logistical feasibility of using the platform in a clinical setting; 3) To determine whether extensive self-questionnaire assessments may impact the use of the Precare platform; 4) To explore barriers and facilitators to enhance patient engagement and knowledge retention; and 5) To derive estimates variables related to gender, ethnicity, cultural background, learners and psychological profiles for future phases.

Our hypotheses are:

1. The Precare platform will exhibit high usability and acceptability.

2. Testing the Precare platform in real clinical settings is viable and will yield promising results for improving patient readiness for Metabolic and Bariatric Surgery.

Conditions

Obesity; Bariatric Surgery Patients; Online Education; eHealth Literacy; Online-Intervention; Usability Satisfaction; Implementation Strategies; Shared Decision Making

Study Design

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

Study Groups

Arm 1: Control arm

Participants will follow the standard protocols of preparation for a bariatric surgery and remain on the waiting list without access to the educational platform (Precare). Participants will have to fulfill the participant's description module and the readiness assessment. After the 6-month assessment, the patient will be providing a full access to Precare and will follow the same assessment process as arm 3 (i.e., Precare usability module, and the secondary clinical assessment module).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2: active arm with a short assessment

Participants randomized to the active arm with a short assessment (arm 2) will be provided with 6-month of full access to the educational platform Precare and will have to fulfill the participant's description module and the readiness assessment (same as arm 1), as well as the Precare usability module.

Group Type: EXPERIMENTAL

Acces to Precare online platform

Intervention Type: OTHER

Precare is an online educational platform for patients on the waiting list for bariatric surgery. Precare offers personalized educational content as well as a calendar and appointment management system. It has been accredited by the Quebec Ministry of Health and Social Services.

Arm 3: active arm with a full assessment

Participants randomized to the active arm with a full assessment (arm 3) will be provided with 6-month of full access to the educational platform Precare after having fulfilled a REDCap module, including the participant's description module, the readiness assessment, the Precare usability module, and the secondary clinical assessment module.

Group Type: EXPERIMENTAL

Acces to Precare online platform

Intervention Type: OTHER

Precare is an online educational platform for patients on the waiting list for bariatric surgery. Precare offers personalized educational content as well as a calendar and appointment management system. It has been accredited by the Quebec Ministry of Health and Social Services.

Interventions

Acces to Precare online platform

Precare is an online educational platform for patients on the waiting list for bariatric surgery. Precare offers personalized educational content as well as a calendar and appointment management system. It has been accredited by the Quebec Ministry of Health and Social Services.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Be on the waiting list for metabolic and bariatric surgery at IUCPQ
• not yet assessed by the local team and with an expected wait time of more than 6 months
• understand French
• Have an active email address

Exclusion Criteria

• Be part of the same household as someone already involved in this research project

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

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Sylvain Iceta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IUCPQ

Québec, Quebec, Canada

Countries

Canada

Central Contacts

Sylvain Iceta, MD, PhD

Role: CONTACT

equipe.iceta@criucpq.ulaval.ca

+1 (418) 656-8711 ext. 4565

Facility Contacts

Sylvain Iceta, Md, PhD

Role: primary

equipe.iceta@criucpq.ulaval.ca

+1 (418) 656-8711 ext. 4565

Other Identifiers

2025-4306

Identifier Type: -

Identifier Source: org_study_id