Effectiveness and Cost-effectiveness of a VCoP to Empowerment of Patients With Ischaemic Heart Disease in PHC: Cluster-RCT (Empodera-dos)
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|ClinicalTrials.gov Identifier: NCT03959631|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : June 6, 2019
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 .
Design: pragmatic cluster randomized clinical trial. Setting: health centres belonging to the Autonomous Communities of Catalonia, Madrid and the Canary Islands. Population: 450 patients with Ischemic Heart Disease in Primary Care. Randomization: randomization unit: health centres; unit of analysis: patients. 4 pairs of health centres will be randomly selected by Autonomous Communities and the intervention group or control group will be randomly assigned. The randomization of the health centres will be carried out after the selection of patients. 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 (Medication Adherence Scale), 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.
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Heart Disease Chronic||Behavioral: Virtual Communities of practice||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Design: pragmatic cluster randomized clinical 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).
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Investigator and outcomes Assessor don´t Know the intervention assigned to each patient|
|Primary Purpose:||Supportive Care|
|Official Title:||Effectiveness and Cost-effectiveness of a Virtual Intervention (VCoP) to Improve the Empowerment of Patients With Ischaemic Heart Disease in Primary Care: Cluster Randomized Controlled Trial|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||November 30, 2021|
Experimental: Intervention group
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
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.
No Intervention: Control group
The control group will not receive any specific intervention. They receive usual care according to actually clinical practice guidelines.
- Patient Activation Measure questionnaire [ Time Frame: Patient Activation Measure measured at 18 months ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959631
|Contact: Garrido Elustondo, Dr.||email@example.com|
|Sofía Garrido elustondo||Not yet recruiting|
|Madrid, Spain, 28028|
|Contact: Garrido Elustondo, Dr. 913016400 ext 204 firstname.lastname@example.org|