Actively Recruiting

Phase Not Applicable
Age: 30Years - 60Years
All Genders
Healthy Volunteers
NCT06046326

Evaluate the Effectiveness of a Virtual Community of Practice

Led by Gerencia de Atención Primaria, Madrid · Updated on 2025-03-12

240

Participants Needed

3

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Objective: To evaluate and compare the effectiveness and cost-effectiveness of a Virtual Community of Practice (VCoP) via a web-based application versus individual and self-administered online education to improve the activation of middle-aged people with multimorbidity. Design: Randomized controlled pragmatic clinical trial with two parallel arms and 18 months follow-up. Setting: Primary health centres and hospitals (Catalonia, Madrid, and the Canary Islands). Population: Middleaged people (30-60 years old) with multimorbidity (≥=2 chronic diseases). Sample size: 240 patients. Randomization: all participants will be randomly assigned to the intervention (VCoP) or the active control group. Data analysis will be blinded to intervention allocation. Intervention: The intervention group will be offered participation for 12 months in a VCoP based on a gamified web-based application. The control group will receive individual, content-focused education through a web platform that will cover the same topics as the VCoP but will be self-administered and without social interaction within the platform. Measurements: The main variable will be measured using the Patient Activation Measure (PAM) questionnaire at baseline, 6, 12 and 18 months. Secondary variables: participant sociodemographics, depression (PHQ-9), anxiety (HADS-A), treatment burden (TBQ), quality of life (EQ-5D-5L), variables related to the use of health resources and to the use of the VCoP. Analysis: Mixed-effects linear regression will be used to determine the effects of the VCoP on the changes in patient activation. Scores at baseline, 6, 12 and 18 months will be included as a fixed effect variable, and the patient and health professional as random effect variables. Analyses will be performed on an intention-to-treat basis. An economic evaluation will be carried out to analyze the cost-effectiveness of the VCoP compared to active control, from the National Health System and social perspectives.

CONDITIONS

Official Title

Evaluate the Effectiveness of a Virtual Community of Practice

Who Can Participate

Age: 30Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Middle-aged people between 30 and 60 years old
  • Diagnosed with two or more chronic diseases
  • Have access to a computer, tablet, or smartphone with internet
  • Able to follow the study requirements and sign informed consent
Not Eligible

You will not qualify if you...

  • Low likelihood of cooperating with the study
  • Being transient, displaced, institutionalized, or having a terminal illness
  • Physical or mental disability that prevents completing questionnaires correctly
  • No available contact phone number or email in the healthcare database

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Gerencia Asistencial Atención Primaria

Madrid, Madrid, Spain, 28035

Actively Recruiting

2

Gerencia Asistencial Atención Primaria

Madrid, Madrid, Spain, 28035

Actively Recruiting

3

González Atención González

Madrid, Madrid, Spain, 28035

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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