Digital Preparation for Bariatric Surgery: Feasability Pilot Trial

Official title

A Pilot Feasibility Study of the Implementation, Usability, Acceptability and Effectiveness of an Online Bariatric Surgery Preparation Platform

Overview

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.

Interventions

• Other 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.

Primary outcome measures

• Self-perceived barriers to metabolic and bariatric surgery [Time frame: At baseline]
• eHeals Literacy Scale [Time frame: At baseline]
• Index of Learning Styles [Time frame: At baseline]
• University of Rhode Island Change Assessment Scale (URICA) [Time frame: At baseline, 3 months and 6 months]
• Home-made survey [Time frame: At baseline, 3 months and 6 months]
• System Usability Scale score(SUS) [Time frame: at 3 and 6 months]

Secondary outcome measures (12)

• Mental Health Continuum Short Form [Time frame: At baseline, 3 months and 6 months]
• Motivation to attempt metabolic and bariatric surgery [Time frame: At baseline]
• Physical and psychological comorbidities [Time frame: At baseline]
• Body Mass Index in kg.m-2 [Time frame: At baseline]
• Age of first weight gain [Time frame: At baseline]
• Weight Loss Attempts [Time frame: At Baseline]
• Adherence to weight loss attempts [Time frame: At baseline]
• Minimal weight [Time frame: At baseline]
• Maximum weight [Time frame: At baseline]
• Binge Eating Scale score [Time frame: At baseline, 3 months and 6 months]
• modified Yale Food Addiction Scale 2.0 (mYFAS 2.0) [Time frame: At baseline, 3 months and 6 months]
• Hospital Anxiety and Depression Scale (HADS) [Time frame: At baseline, 3 months and 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Canada · 1 center

• IUCPQ — Québec

Identifiers

NCT: NCT07201870 · 2025-4306

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗