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Cardiovascular medicine
Protocol
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
  1. Ana Isabel González-González1,2,
  2. Lilisbeth Perestelo-Pérez3,4,
  3. Débora Koatz5,6,
  4. Marta Ballester5,6,
  5. Valeria Pacheco-Huergo5,7,
  6. Vanesa Ramos-García8,
  7. Alezandra Torres-Castaño8,
  8. Amado Rivero-Santana3,4,
  9. Ana Toledo-Chávarri4,8,
  10. Cristina Valcárcel-Nazco8,
  11. Juana Mateos-Rodilla9,
  12. Juan Carlos Obaya-Rebollar10,
  13. Javier García-García11,
  14. Santiago Díaz-Sánchez12,
  15. Luis Morales-Cobos13,
  16. Josep María Bosch-Fontcuberta14,15,
  17. Nuria Vallejo-Camazón16,
  18. Ana Rodríguez-Almodovar17,
  19. José Carlos del Castillo18,
  20. Marcos Muñoz-Balsa19,
  21. Yolanda del Rey-Granado19,
  22. Sofía Garrido-Elustondo20,
  23. María-Eugenia Tello-Bernabé21,
  24. Ana Belén Ramírez-Puerta19,
  25. Carola Orrego5,6
  1. 1Goethe-Universitat Frankfurt am Main Institut fur Allgemeinmedizin, Frankfurt am Main, Hessen, Germany
  2. 2Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Gerencia Asistencial de Atención Primaria, Servicio Madrileño de Madrid, Madrid, Spain
  3. 3Servicio de Evaluación y Planificación del Servicio Canario de la Salud, Tenerife, Spain
  4. 4Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Tenerife, Spain
  5. 5Avedis Donabedian Research Institute (FAD), Barcelona, Spain
  6. 6Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Barcelona, Spain
  7. 7Centro de Atención Primaria Turó, Instituto Catalán de la Salud, Barcelona, Spain
  8. 8Fundación Canaria Instituto de Investigación Sanitaria de Canarias (FISC), Tenerife, Spain
  9. 9Escuela Madrileña de Salud, Dirección General de Humanización y Atención al Paciente, Madrid, Spain
  10. 10Centro de Salud Chopera, Gerencia Asistencial de Atención Primaria, Madrid, Spain
  11. 11Unidad de Calidad y Seguridad del Paciente. Hospital Universitario Nuestra Señora de Candelaria, Tenerife, Spain
  12. 12Centro de Salud Pintores, Gerencia Asistencial de Atención Primaria, Madrid, Spain
  13. 13Centro de Salud Las Américas, Gerencia Asistencial de Atención Primaria, Madrid, Spain
  14. 14Centro de Atención Primaria Encants, Instituto Catalán de la Salud, Barcelona, Spain
  15. 15Departament de Medicina Area de Medicina, Universitat Autonoma de Barcelona, Barcelona, Catalunya, Spain
  16. 16Hospital Germans Trias i Pujol, Badalona, Catalunya, Spain
  17. 17UGC Cardiología, Hospital Universitario Reina Sofía, Códoba, Spain
  18. 18Cardiovascular Area, Hospital San Juan de Dios, Tenerife, Canarias, Spain
  19. 19Unidad de Apoyo Técnico, Gerencia Asistencial Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain
  20. 20Centre Family and Community Care Teaching Multiprofessional Unit, Comunidad de Madrid Consejeria de Sanidad, Madrid, Spain
  21. 21Centro de Salud El Naranjo, Gerencia Asistencial Atención Primaria, Servicio Madrileño de Salud, Madrid, Spain
  1. Correspondence to Dr Ana Isabel González-González; gonzalezgonzalez{at}allgemeinmedizin.uni-frankfurt.de

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.

  • coronary heart disease
  • general medicine (see internal medicine)
  • geriatric medicine
  • adult cardiology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2020-037374

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    Footnotes

    • Twitter @Inst_Donabeidan

    • Contributors AIG-G wrote the initial draft of the protocol. CO is the guarantor of the trial. AIG-G, CO, LP-P, DK, VP-H and MB conceived the project. SG-E, AR-R and CV-N provided the methodological guidance. AT-C, VR-G, AT-C, JM-R, JCO-R, SD-S, LM-C, JG-G, NV-C, AR-A, JCdC, JMB-F, M-ET-B, MMB, YdR-G and ABR-P are co-supervisors of this project, providing advice at all stages of the development of the protocol, and contributed to the revision of the manuscript. All authors read and approved the final manuscript.

    • Funding This study has been funded by Instituto de Salud Carlos III through the project ‘PI18/01404, PI18/01397, PI18/01333’, Co-funded by European Regional Development Fund, (ERDF) ‘A way of shaping Europe’.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.