Full Title: Effectiveness and cost-effectiveness of a virtual community of practice for enhancing empowerment in middle-aged individuals with multimorbidity: RCT

Funded by: Instituto de Salud Carlos III (FIS PI22/00691)

Grant awarded: €45,980.00

Duration: 3 years (2023-2025)

Principal Investigator: Lilisbeth Perestelo Pérez

Associated Researchers: Analía Abt Sacks, Andrea Duarte Díaz, Aránzazu Hernández Yumar, Alezandra Torres Castaño, Beatriz González de León, M. Consuelo Company Sancho, Candelaria Martín González, Javier García García, José Ramón Vázquez Díaz, Santiago Domínguez Coello, Vanesa Ramos García, Yolanda Álvarez Pérez

Project Summary

Objective: Evaluate and compare the effectiveness and cost-effectiveness of a Virtual Community of Practice (CdPV) versus individual and self-administered online education to enhance activation in middle-aged individuals with multimorbidity. Design: Randomized controlled trial, pragmatic, blinded to intervention assignment, multicenter with 2 parallel arms and an 18-month follow-up. Setting: Primary care centers and hospitals (Canarias, Cataluña, and Madrid). Population: Middle-aged individuals (30-60 years) with multimorbidity (≥2 chronic diseases). Sample Size: 240 patients. Randomization: Random allocation to the intervention group (CdPV) or active control. Data analysis will be blinded to intervention assignment. Intervention: The intervention group will participate for 12 months in a CdPV via a gamified web application. The control group will receive individual, self-administered education with no social interaction within the platform. Measurements: Patient activation level (primary variable) (PAM) (baseline, 6, 12, and 18 months). Secondary Variables: Sociodemographic data, depression (PHQ-9), anxiety (HADS-A), treatment burden (TBQ), health-related quality of life (EQ-5D-5L), resource utilization, and CdPV usage. Analysis: Linear mixed-effects regression of repeated measures to determine the effects of the CdPV on changes in patient activation and secondary variables. Scores at different time points (baseline, 6, 12, and 18 months) will be included as fixed effects, and patient and professional will be included as random effects. Analyses will be conducted by intention-to-treat. An economic evaluation will assess the cost-effectiveness of the CdPV compared to active control from both the National Health System and social perspectives.

Contact Person: Lilisbeth Perestelo Pérez (lilisbeth.peresteloperez@sescs.es)