Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03959631 |
| Other study ID # |
PI18/01397 |
| Secondary ID |
PI18/01333PI 18/ |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 11, 2021 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
Gerencia de Atención Primaria, Madrid |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Methods:
Design: pragmatic randomized controlled 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: 246 patients with Heart Disease in Primary Care. (123 patients per arm) .
Randomization: patients will be randomly assigned to the intervention (VCoP) or control
group. The 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 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: Will be assessed with the Adherence Refill and Medication Adherence
Scale (ARMS-e), validated in Spain and used to measure adherence to medication in patients
with chronic diseases. It consists of 12 questions and there is no cut-off point, the lower
the score, the better the adherence. To quantify adherence, a value of 1 to 4 (never,
sometimes, almost always or always) is assigned to each of the responses according to a
Likert-type scale.
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.
