Evaluate the Effectiveness of a Virtual Community of Practice

NCT06046326 | Recruiting

• 1 other identifier: PI22/01124
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Chronic Diseases

Keywords

Chronic Diseases; Virtual community of practice empowerment

Outcome Measures

Primary Outcomes (3)

• the Patient Activation Measure (PAM)

  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.

  Baseline

• the Patient Activation Measure (PAM)

  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.

  12 months

• the Patient Activation Measure (PAM)

  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.

  18 months

Secondary Outcomes (12)

• Patient Health Questionnaire-9

  Baseline

• Patient Health Questionnaire-9

  12 months

• Patient Health Questionnaire-9

  18 months

• Hospital Anxiety and Depression Scale (HADS)

  Baseline

• Hospital Anxiety and Depression Scale (HADS)

  12 months

Study Arms (2)

virtual community of practice

EXPERIMENTAL

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

Behavioral: virtual community of practice

control group

NO INTERVENTION

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 theplatform.

Interventions

virtual community of practice BEHAVIORAL

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

virtual community of practice

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: 30 - 60 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead

Study Sites (3)

Gerencia Asistencial Atención Primaria

Madrid, Madrid, 28035, Spain

RECRUITING

Gerencia Asistencial Atención Primaria

Madrid, Madrid, 28035, Spain

RECRUITING

González Atención González

Madrid, Madrid, 28035, Spain

RECRUITING

Related Publications (1)

• Campillejo A, Gefaell-Larrondo I, Ramos-Garcia V, Koatz D, Santos-Alvarez A, Barrio-Cortes J, Gomez-Rueda S, Calderon-Larranaga A, Cifuentes P, Company-Sancho C, Dominguez-Coello S, Garcia-Garcia FJ, Garrido-Elustondo S, Gonzalez de Leon B, Ramon-Vazquez J, Martin C, Suarez-Fernandez C, Parra-Caballero P, Vicente-Rabaneda EF, Quiroga-Colina P, Ramirez-Puerta AB, Ruiz-Lopez M, Tello-Bernabe ME, Sanchez-Gamborino E, Ugalde-Abiega B, Vall-Roque H, Duarte-Diaz A, Abt-Sacks A, Hernandez-Yumar A, Torres-Castano A, Alvarez-Perez Y, Muth C, van den Akker M, Montori VM, Orrego C, Perestelo-Perez L, Gonzalez-Gonzalez AI. 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.

  PMID: 38803252 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: September 21, 2023
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)