RecruitingNot ApplicableNCT06046326

Evaluate the Effectiveness of a Virtual Community of Practice

Evaluate the Effectiveness of a Virtual Community of Practice Via a Web-based Application Versus Individual and Self-administered Online Education to Improve the Activation of Middle-aged People with Multimorbidity.


Sponsor

Gerencia de Atención Primaria, Madrid

Enrollment

240 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 30 YearsMax Age: 60 Years

Inclusion Criteria2

  • Middleagedpeople (30-60 years old)
  • with multimorbidity (≥=2 chronic diseases).

Exclusion Criteria3

  • Low probability of cooperation in the study
  • situation of transients or displaced persons, institutionalized, with some terminal illness, physical or mental disability that prevents them from answering the questionnaires correctly.
  • When the contact telephone number/email is not available in the CAP/hospital database.

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Interventions

BEHAVIORALvirtual community of practice

The intervention group will be offered participation for 12 months in a VCoP based ona gamified web-based application.


Locations(3)

Gerencia Asistencial Atención Primaria

Madrid, Madrid, Spain

Gerencia Asistencial Atención Primaria

Madrid, Madrid, Spain

González Atención González

Madrid, Madrid, Spain

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NCT06046326


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