Effectiveness and Cost-effectiveness of a VCoP to Empowerment of Patients With Ischaemic Heart Disease in PHC: Cluster-RCT

NCT03959631 | Completed

• 3 other identifiers: PI18/01397PI18/01333PI 18/01404
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: to evaluate the effectiveness and estimate the costs of a Virtual Community of Practice in the improvement of the activation of patients with Ischemic Heart Disease in Primary Care . Methods: Design: pragmatic randomized controlled multicentric trial. Setting: health centres belonging to the Autonomous Communities of Catalonia, Madrid and the Canary Islands. Population: 246 patients with Ischemic Heart Disease in Primary Care. Randomization: randomization will be central and automatically performed by the online "e-mpodera" platform and the assigned group will be communicated to the patient once he or she has entered the platform and completed baseline assessment. Intervention: the intervention group will be offered participation for 6 months in a Virtual Community of Practice based on a web 2.0 platform in which there is interaction with other patients and with a multidisciplinary team of professionals. The intervention will be co-designed with a group of patients and a group of primary and specialized care professionals. The control group will receive usual care. Measurements: the main variable will be measured using the Patient Activation Measure questionnaire at baseline, 6, 12 and 18 months. Secondary variables: sociodemographic and clinical variables of the patients; knowledge test (questionnaire of risk cardiovascular factories , attitudes (Self-efficacy Managing Chronic Disease Scale ), adherence to Mediterranean diet (Mediterranean Diet), level of physical activity (International Physical Activity Questionnaire), medication adherence (Adherence Refill and Medication Scale (ARMS-e), depression (Patient Health Questionnaire), anxiety (Hospital Anxiety and Depression Scale), quality of life (EQ-5D-5L); variables related to the use of health resources; variables related to the use of the Virtual Community of Practice . Data will be collected from self-reported questionnaires and the electronic medical records. Analysis: a linear regression model of mixed effects will be estimated to estimate the effect of participating in the Virtual Community of Practice. In addition, subgroup analyses will be carried out and indicators of the functioning of the Virtual Community of Practice will be measured through techniques of Social Network Analysis and Control Charts. There will be an economic evaluation of the Virtual Community of Practice from the perspective of the National Health System and from the social perspective.

Conditions

Ischemic Heart Disease Chronic

Keywords

Ischemic Heart Disease Virtual Community of Practice empowerment

Outcome Measures

Primary Outcomes (1)

• Patient Activation Measure questionnaire

  It has 13 items, measured with a Likert scale (from 1 to 4). This questionnaire values activation in patients with chronic diseases. It evaluates people's knowledge and skills in self-care. Puntuation is 0 to 100 (best puntuation)

  Patient Activation Measure measured at 18 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will be offered participation for 6 months in a Virtual Communities of practice based on a web 2.0 platform in which there is interaction with other patients and with a multidisciplinary team of professionals. The intervention will be co-designed with a group of patients and a group of primary and specialized care professionals.

Behavioral: Virtual Communities of practice

Control group

NO INTERVENTION

The control group will not receive any specific intervention. They receive usual care according to actually clinical practice guidelines.

Interventions

Virtual Communities of practice BEHAVIORAL

based on a web 2.0 platform in which there is interaction with other patients and with a multidisciplinary team of professionals. The intervention will be co-designed with a group of patients and a group of primary and specialized care professionals.

Intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be able to follow the requirements of the study
• having signed informed consent for participation in the study.

You may not qualify if:

• low probability of cooperation in the study
• bystanders or displaced status
• institutionalized, with a terminal illness, physical or mental disability that prevents respond to questionnaires properly.

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead
• Avedis Donabedian Research Institute: collaborator
• Servicio Canario de Salud: collaborator

Study Sites (1)

Sofía Garrido elustondo

Madrid, 28028, Spain

Location

Related Publications (5)

• Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.

  PMID: 23381511 BACKGROUND

• Mosen DM, Schmittdiel J, Hibbard J, Sobel D, Remmers C, Bellows J. Is patient activation associated with outcomes of care for adults with chronic conditions? J Ambul Care Manage. 2007 Jan-Mar;30(1):21-9. doi: 10.1097/00004479-200701000-00005.

  PMID: 17170635 BACKGROUND

• Salvado-Hernandez C, Cosculluela-Torres P, Blanes-Monllor C, Parellada-Esquius N, Mendez-Galeano C, Maroto-Villanova N, Garcia-Cerdan RM, Nunez-Manrique MP, Barrio-Ruiz C, Salvador-Gonzalez B; en representacion del grupo de investigacion del proyecto COIB 5367-11. [Heart failure in primary care: Attitudes, knowledge and self-care]. Aten Primaria. 2018 Apr;50(4):213-221. doi: 10.1016/j.aprim.2017.03.008. Epub 2017 Jun 23. Spanish.

  PMID: 28652033 BACKGROUND

• Vall-Roque H, Ramos-Garcia V, Rivero-Santana A, Torres-Castano A, Cifuentes P, Koatz D, Garcia-Garcia J, Pacheco-Huergo V, Rello P, Santos-Alvarez A, Campillejo Garcia A, Garrido Elustondo S, Sanmartin M, Perestelo-Perez L, Gonzalez-Gonzalez AI, Orrego C. A virtual community of practice to empower patients with recent ischemic heart disease: A randomized controlled trial. Health Psychol. 2025 Jun;44(6):630-642. doi: 10.1037/hea0001439. Epub 2024 Dec 16.

  PMID: 39679979 DERIVED

• Gonzalez-Gonzalez AI, Perestelo-Perez L, Koatz D, Ballester M, Pacheco-Huergo V, Ramos-Garcia V, Torres-Castano A, Rivero-Santana A, Toledo-Chavarri A, Valcarcel-Nazco C, Mateos-Rodilla J, Obaya-Rebollar JC, Garcia-Garcia J, Diaz-Sanchez S, Morales-Cobos L, Bosch-Fontcuberta JM, Vallejo-Camazon N, Rodriguez-Almodovar A, Del Castillo JC, Munoz-Balsa M, Del Rey-Granado Y, Garrido-Elustondo S, Tello-Bernabe ME, Ramirez-Puerta AB, Orrego C. 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. BMJ Open. 2020 Oct 12;10(10):e037374. doi: 10.1136/bmjopen-2020-037374.

  PMID: 33046465 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes Assessor don´t Know the intervention assigned to each patient
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist

Model Details: Design: pragmatic randomized controlled trial, with two parallel arms, multicenter, 18 months of follow-up Setting Primary Care Centres belonging to the Autonomous Communities of Catalonia, (329), Madrid (262) and the Canary Islands (102).

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 22, 2019
• Study Start: January 11, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 18 months
• Access Criteria: Only researchers can Access to the study data.

Locations

ES (1)