Implementation of a virtual community of practice to promote the empowerment of middle-aged people with multimorbidity: study protocol of a randomised controlled trial

BMJ Open. 2024 May 24;14(5):e084937. doi: 10.1136/bmjopen-2024-084937.

Abstract

Introduction: Empowering people living with multimorbidity (multiple chronic conditions) to gain greater confidence in managing their health can enhance their quality of life. Education focused on self-management is a key tool for fostering patient empowerment and is mostly provided on an individual basis. Virtual communities of practice (VCoP) present a unique opportunity for online education in chronic condition self-management within a social context. This research aims to evaluate the effectiveness/cost-effectiveness of individualised, online self-management education compared with VCoP among middle-aged individuals living with multiple chronic conditions.

Methods and analysis: People aged 30-60, living with ≥2 chronic conditions and receiving care in primary care (PC) centres and outpatient hospital-based clinics in Madrid and Canary Islands will enrol in an 18-month parallel-design, blinded (intervention assessment and data analysts), pragmatic (adhering to the intention-to-treat principle), individually randomised trial. The trial will compare two 12-month web-based educational offers of identical content; one delivered individually (control) and the other with online social interaction (VCoP, intervention). Using repeated measures mixed linear models, with the patient as random effect and allocation groups and time per group as fixed effects, we will estimate between-arm differences in the change in Patient Activation Measure from baseline to 12 months (primary endpoint), including measurements at 6-month and 18-month follow-up. Other outcomes will include measures of depression and anxiety, treatment burden, quality of life. In addition to a process evaluation of the VCoP, we will conduct an economic evaluation estimating the relative cost-effectiveness of the VCoP from the perspectives of both the National Health System and the Community.

Ethics and dissemination: The trial was approved by Clinical Research Ethics Committees of Gregorio Marañón University Hospital in Madrid/Nuestra Señora Candelaria University Hospital in Santa Cruz de Tenerife. The results will be disseminated through workshops, policy briefs, peer-reviewed publications and local/international conferences.

Trial registration number: NCT06046326.

Keywords: Chronic Disease; Clinical Trial; Community-Based Participatory Research; GENERAL MEDICINE (see Internal Medicine); Self-Management.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Community of Practice
  • Cost-Benefit Analysis
  • Empowerment*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Multimorbidity*
  • Patient Education as Topic / methods
  • Quality of Life*
  • Randomized Controlled Trials as Topic
  • Self-Management / education
  • Self-Management / methods
  • Spain

Associated data

  • ClinicalTrials.gov/NCT06046326