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Recruiting Not applicable

Evaluate the Effectiveness of a Virtual Community of Practice

NCT06046326 · tracked via the Priya Life Science Spain tracker
Sponsor
Gerencia de Atención Primaria, Madrid
Phase
Not applicable
Started
2024-06-01
Last updated
2025-03-12

Condition(s) studied

Chronic Diseases

Investigational drug(s) / intervention(s)

virtual community of practice

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

Study 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

Sex
ALL
Min age
30 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Middleagedpeople (30-60 years old) * with multimorbidity (≥=2 chronic diseases). Exclusion Criteria: * 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.

Primary outcome measure(s)

  • the Patient Activation Measure (PAM) — Baseline
    It consists of 13 items that assess people's knowledge, skills, and confidence in self-care for their health and medical care, measured using a 1-4 Likert scale with a total score that is transferred to a scale between 0 and 100.
  • the Patient Activation Measure (PAM) — 12 months
    It consists of 13 items that assess people's knowledge, skills, and confidence in self-care for their health and medical care, measured using a 1-4 Likert scale with a total score that is transferred to a scale between 0 and 100.
  • the Patient Activation Measure (PAM) — 18 months
    It consists of 13 items that assess people's knowledge, skills, and confidence in self-care for their health and medical care, measured using a 1-4 Likert scale with a total score that is transferred to a scale between 0 and 100.

Trial sites (3)

FacilityCityRegionStatus
Gerencia Asistencial Atención Primaria Madrid Madrid Recruiting
Gerencia Asistencial Atención Primaria Madrid Madrid Recruiting
González Atención González Madrid Madrid Recruiting

More Gerencia de Atención Primaria, Madrid trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06046326 on ClinicalTrials.gov ↗ ← All trials in Spain