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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
Sponsor:
Collaborators:
Avedis Donabedian Research Institute
Servicio Canario de Salud
Information provided by (Responsible Party):
Sofia Garrido Elustondo, Gerencia de Atención Primaria, Madrid

Study Description
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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 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

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active diagnosis of ischemic heart disease in the year prior to inclusion in the study; have Internet at home or phone
  • be able to follow the requirements of the study
  • having signed informed consent for participation in the study.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Garrido Elustondo, Dr. 913019405 sgarrido@salud.madrid.org

Locations
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Spain
Sofía Garrido elustondo Not yet recruiting
Madrid, Spain, 28028
Contact: Garrido Elustondo, Dr.    913016400 ext 204    sgarrido@salud.madrid.org   
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Avedis Donabedian Research Institute
Servicio Canario de Salud
More Information
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Publications:

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Responsible Party: Sofia Garrido Elustondo, Epidemiologist, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier: NCT03959631     History of Changes
Other Study ID Numbers: PI18/01397
PI18/01333 ( Other Grant/Funding Number: Servicio de Evaluación del Servicio canario de la Salud )
PI 18/01404 ( Other Grant/Funding Number: Avedis Donabedian Research Institute )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be collected from self-reported questionnaires and the electronic medical records.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 18 months
Access Criteria: Only researchers can Access to the study data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sofia Garrido Elustondo, Gerencia de Atención Primaria, Madrid:
Ischemic Heart Disease Virtual Community of Practice empowerment
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
 Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases