Effectiveness and cost-effectiveness of a virtual community of practice to improve the empowerment of patients with ischaemic heart disease: study protocol of a randomised controlled trial

Ana Isabel González-González, Lilisbeth Perestelo-Pérez, Débora Koatz, Marta Ballester, Valeria Pacheco-Huergo, Vanesa Ramos-García, Alezandra Torres-Castaño, Amado Rivero-Santana, Ana Toledo-Chávarri, Cristina Valcárcel-Nazco, Juana Mateos-Rodilla, Juan Carlos Obaya-Rebollar, Javier García-García, Santiago Díaz-Sánchez, Luis Morales-Cobos, Josep María Bosch-Fontcuberta, Nuria Vallejo-Camazón, Ana Rodríguez-Almodovar, José Carlos Del Castillo, Marcos Muñoz-Balsa, Yolanda Del Rey-Granado, Sofía Garrido-Elustondo, María-Eugenia Tello-Bernabé, Ana Belén Ramírez-Puerta, Carola Orrego, Ana Isabel González-González, Lilisbeth Perestelo-Pérez, Débora Koatz, Marta Ballester, Valeria Pacheco-Huergo, Vanesa Ramos-García, Alezandra Torres-Castaño, Amado Rivero-Santana, Ana Toledo-Chávarri, Cristina Valcárcel-Nazco, Juana Mateos-Rodilla, Juan Carlos Obaya-Rebollar, Javier García-García, Santiago Díaz-Sánchez, Luis Morales-Cobos, Josep María Bosch-Fontcuberta, Nuria Vallejo-Camazón, Ana Rodríguez-Almodovar, José Carlos Del Castillo, Marcos Muñoz-Balsa, Yolanda Del Rey-Granado, Sofía Garrido-Elustondo, María-Eugenia Tello-Bernabé, Ana Belén Ramírez-Puerta, Carola Orrego

Abstract

Introduction: Virtual Communities of Practice (VCoP) or knowledge-sharing virtual communities offer ubiquitous access to information and exchange possibilities for people in similar situations, which might be especially valuable for the self-management of patients with chronic diseases. In view of the scarce evidence on the clinical and economic impact of these interventions on chronic conditions, we aim to evaluate the effectiveness and cost-effectiveness of a VCoP in the improvement of the activation and other patient empowerment measures in patients with ischaemic heart disease (IHD).

Methods and analysis: A pragmatic randomised controlled trial will be performed in Catalonia, Madrid and Canary Islands, Spain. Two hundred and fifty patients with a recent diagnosis of IHD attending the participating centres will be selected and randomised to the intervention or control group. The intervention group will be offered participation for 12 months in a VCoP based on a gamified web 2.0 platform where there is interaction with other patients and a multidisciplinary professional team. Intervention and control groups will receive usual care. The primary outcome will be measured with the Patient Activation Measure questionnaire at baseline, 6, 12 and 18 months. Secondary outcomes will include: clinical variables; knowledge (Questionnaire of Cardiovascular Risk Factors), attitudes (Self-efficacy Managing Chronic Disease Scale), adherence to the Mediterranean diet (Mediterranean Diet Questionnaire), level of physical activity (International Physical Activity Questionnaire), depression (Patient Health Questionnaire), anxiety (Hospital Anxiety Scale-A), medication adherence (Adherence to Refill Medication Scale), quality of life (EQ-5D-5L) and health resources use. Data will be collected from self-reported questionnaires and electronic medical records.

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

Trial registration number: ClinicalTrials.gov Registry (NCT03959631). Pre-results.

Keywords: adult cardiology; coronary heart disease; general medicine (see internal medicine); geriatric medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow of participants. ARMS, Adherence Refill and Medication Scale; CdPV, Comunidad de Práctica Virtual; HADS-A, Hospital Anxiety and Depression Scale; IPAQ, International Physical Activity Questionnaire; PAM, Patient Activation Measure; PHQ-9, Patient Health Questionnaire; SMCDS, Self-efficacy Managing Chronic Disease Scale.

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