Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date June 6, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03959631 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness and Cost-effectiveness of a VCoP to Empowerment of Patients With Ischaemic Heart Disease in PHC: Cluster-RCT
Official Title  ICMJE 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
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.

Detailed Description

Methods:

Design: pragmatic cluster randomized clinical trial, with two parallel arms, multicenter, 18 months of follow-up.

Time Frame: 18 months.

Setting Primary Care Centres belonging to the Autonomous Communities of Catalonia, (329), Madrid (262) and the Canary Islands (102).

Study Population: patients with a recent diagnosis of ischemic heart disease in follow-up by Primary Care (diagnosis of ischemic heart disease in the year prior to inclusion in the study).

Inclusion criteria: age over 18 years; 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.

Population: 450 patients with Heart Disease in Primary Care . Randomization: randomization unit: primary care health centres; unit of analysis: patients with ischemic heart disease. 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 not receive any specific intervention. They receive usual care according to actually clinical practice guidelines.

Measurements:

  • Main Variable: Patient Activation Measure questionnaire. This questionnaire values activation in patients with chronic diseases. It consists of 13 items that evaluate people's knowledge, skills and confidence in self-care for their health and medical care. Measured by a scale type Likert 1-4 with a total score between 0 and 100. 0 is the worst puntuation and 100 is the best puntuation.
  • Knowledge about the disease, assessed through a self-administered self-made questionnaire. The questionnaire will measure the level of knowledge about secondary prevention of cardiovascular disease and will be based on the Questionnaire of Factors of Risk Cardiovascular previous translation-back translation and adaptation to the Spanish population.
  • Attitude of the patient, measured from the self-administered self-efficacy Managing Chronic Disease Scale questionnaire . This questionnaire was developed to assess the self-efficacy or confidence perceived by the person to perform self-care activities for the management of their chronic disease. Includes 6 items with aspects such as fatigue, emotions and treatment with response from 1 (no confidence) to 10 (totally confident); the average final score of all the items is calculated (the higher the score, the more self-efficacy). This questionnaire has been translated into Spanish and used in our context in people with heart failure
  • Adhesion to the Mediterranean diet from the Mediterranean Diet questionnaire It is a set of 14 short questions whose evaluation aims to provide information on adherence to the Mediterranean diet pattern. Scores below 7 indicate low adherence; Scores above 10 indicate good adherence. It has been validated in the Spanish population in the PREDIMED study .

International Physical Activity Questionnaire. This questionnaire has been used in several international studies and its validity has been evaluated recommending its use in different countries and languages The short version provides information on the time spent walking, in activities of moderate and vigorous intensity and in sedentary activities. Evaluates three specific characteristics of the activity: intensity (mild, moderate, vigorous), frequency (measured in days per week) and duration (time per day). After calculating the physical activity index, whose value corresponds to the product of the intensity (in METS) by the frequency, and by the duration of the activity) the patients are classified into three categories: low, medium and high.

Depression - Patient Health Questionnaire-9 .It is an instrument that not only allows detecting people with depressive disorder, but also allows to define the severity of the condition and to follow up on these people. It has been validated to Spanish demonstrating behavior similar to the original in English and a good acceptance by patients . It is a short instrument, designed to be self-administered. It consists of 9 items that assess the presence of depressive symptoms (corresponding to the DSM-IV criteria) present in the last 2 weeks. Each item has a severity index corresponding to: 0 = "never", 1 = "some days", 2 = "more than half of the days" and 3 = "almost every day".

Anxiety - Hospital Anxiety and Depression Scale. This scale is a 14-item questionnaire that was initially designed for the evaluation of anxiety and depression in non-psychiatric outpatient hospital services. It is a useful instrument validated in our setting and of special interest and usefulness in the context of PA. It is a measure composed of two sub-scales (Hospital Anxiety and Depression - A and Hospital Anxiety and Depression - D), of seven items each that are scored from 0 to 3. The authors recommend the points of 8 for possible cases and> 10 for cases probable in both sub-scales. One of its main virtues is the suppression of somatic symptoms so that it can be evaluated independently of the underlying somatic disease. However, in patients with coronary artery disease, it has been found that it underestimates people with depression , while the Hospital Anxiety and Depression - A sub-scale has a good specificity and predictive value to measure anxiety in this context.

Adherence to medication: One Medication Adherence Scale, that is a self-reported measure of medication-taking behavior widely used in different cultures. It has been validated in Spanish in various contexts. It has also been used to measure adherence to medication in patients with coronary disease . It measures specific adherence behaviors, with questions whose answer alternatives are YES / NO, and a question on a Likert scale. The adherence is determined according to their score, classifying as adherents the patients with 8 points and non-adherent with scores less than 8.

Quality of life related to health - E5-5D-5L The EQ-5D, developed by the EuroQol Group (www.euroqol.org), is a generic and standardized instrument designed to describe and assess the quality of life related to health in both relatively healthy individuals (general population) and in groups of patients with different pathologies. It has been prepared in several languages, including Spanish, and used in various contexts, including the PA . The EQ-5D was born to try to offer a measure of self-perceived health that incorporated the individual preferences (utilities) on health status and that would serve as a measure of effectiveness in the economic evaluation of health technologies and health policies. It allows to reflect the quality of life associated with health, with the amount of life and offer a value of the gains in health, the Quality Adjusted Life Year (QALY). It consists of 2 parts: the person assesses their state of health, first in levels of severity by dimensions (descriptive system) and then in a visual analog scale (EVA) of more general evaluation. A third element of the EQ-5D is the index of social values obtained for each health state generated by the instrument. The descriptive EQ-5D system comprises 5 dimensions (mobility, personal care, daily activities, pain / discomfort and anxiety / depression). In the EVA the individual scores his health between two extremes, 0 and 100, worse and better state of health imaginable. The EQ-5D is available in two versions for adults, with 3 levels and 5 levels of response options, EQ-5D-3L and EQ-5D-5L, respectively. The EQ-5D-5L has shown to be a valid extension of the EQ-5D-3L that improves the measurement properties.

Use of health resources through a self-administered questionnaire contrasted with Clinical History information: visits to the doctor and / or nurse in the last 3 months, hospital admissions during the intervention, temporary or permanent ITs (number and time).

Explanatory and adjustment variables:

Of the patient (first level): Sociodemographic: age, sex, nationality, Autonomous Communities of residence, marital status (married / couple, single, separated, divorced, widowed), educational level (incomplete primary studies, complete primary education, education secondary school, university studies or equivalent), lives alone (yes / no), current occupation; Morbidity: type (stable angina, unstable angina, AMI), duration of ischemic heart disease (months), ventricular ejection fraction (≤ 35%,> 35%), classification of the New York Heart Association (I-IV), number and description of chronic concomitant diseases (O'Halloran list (63)); Treatment: pharmacological (acetylsalicylic acid or clopidogrel, beta-blockers, statins, other treatments), participation in a cardiac rehabilitation program before and during the study period (yes / no). This information will be collected from a self-administered self-prepared questionnaire contrasted with information from the Clinical History.

Clinics: blood pressure, body mass index (BMI), lipid profile (HDL-C, LDL-C), smoking habit, number and frequency of anginal episodes. These variables will be collected through a self-administered self-prepared questionnaire contrasted with information from the Clinical History.

Analysis

An analysis of multilevel mixed models is proposed for the main result, where the response variable will be the difference between the final and initial score obtained in the attitude questionnaire administered to the participating professionals and the explanatory variable will be the dichotomous intervention variable (1 = Virtual Community of Practice / 0 = Control). This model will consider the co-variables age, sex and clinical characteristics of the patient with Heart Disease and will take into account the random effect associated with Primary Care Centre. To control a possible selection bias and increase the accuracy of the model, the Propensity Score will be used. The analyzes will be carried out by intention to deal with the statistical software R Core Team (2014) http://www.R-project.org/ and Statistical Package for the Social Sciences 18.

Analysis: a linear regression model of mixed effects will be estimated to estimate the effect of participating in theVirtual 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Ischemic Heart Disease Chronic
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Virtual Communities of practice
  • No Intervention: Control group
    The control group will not receive any specific intervention. They receive usual care according to actually clinical practice guidelines.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Garrido Elustondo, Dr. 913019405 sgarrido@salud.madrid.org
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959631
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be collected from self-reported questionnaires and the electronic medical records.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 18 months
Access Criteria: Only researchers can Access to the study data.
Responsible Party Sofia Garrido Elustondo, Gerencia de Atención Primaria, Madrid
Study Sponsor  ICMJE Gerencia de Atención Primaria, Madrid
Collaborators  ICMJE
  • Avedis Donabedian Research Institute
  • Servicio Canario de Salud
Investigators  ICMJE Not Provided
PRS Account Gerencia de Atención Primaria, Madrid
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP