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

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• Avedis Donabedian Research Institute

  collaborator OTHER

• Servicio Canario de Salud

  collaborator OTHER

• Gerencia de Atención Primaria, Madrid

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-11

Primary Completion

2022-11-30

Completion

2022-11-30

Countries

• Spain

Study Locations