Patient Centered Care in Diabetes in Ecuador

Sponsor
Universidad Miguel Hernandez de Elche (Other)
Overall Status
Completed
CT.gov ID
NCT04592263
Collaborator
Universidad Catolica Santiago de Guayaquil (Other), Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (Other)
524
3
25.9
174.7
6.7

Study Details

Study Description

Brief Summary

Introduction: According to World Health Organization data, it is estimated that more than 422 million people have diabetes. In Ecuador, diabetes is the second cause of death, only after ischemic heart disease, and is the first chronic non-communicable disease. The complexity of the pathology, its difficult management and the patient's commitment and involvement in their own care has led health systems to seek mechanisms to activate patients. Currently, tools have been developed, Patient Reported Experience Measures (PREM) and Patient Reported Outcome Measures (PROM), which seek to reduce this gap between patient and health system.

Objectives: To develop and validate PREM and PROM tools for diabetes in the Ecuadorian context. To achieve better clinical results and greater patient satisfaction with the system, thus adding value to the care process of patients with diabetes.

Method: This is a study with two components. The first component will focus on the design and validation of PREM and PROM tools in Ecuador. A second component, consisting of a prospective cohort study for the corresponding implementation of the questionnaires obtained and their validation.

Expected results: It is expected to involve patients in the care process, thus establishing a framework for achieving better clinical outcomes and greater patient satisfaction with the system.

Condition or Disease Intervention/Treatment Phase
  • Other: EPD Questionnaire

Detailed Description

Diabetes is considered a worldwide health problem. Its prevalence is increasing every year despite efforts by health systems in different countries to reduce its impact. Most studies have focused on prevention and the effectiveness of drug treatment and diabetes education. However, in order to achieve greater adherence to therapy we must incorporate one more measure, the activation of patients suffering from this condition. This activation is based, above all, on the perception of self-efficacy, life experience in the face of the disease, confidence that adequate care is being received, and the positive assessment that a better result is being achieved. To achieve this, health systems are committed to redesigning the care process to achieve better short and long term results through the inclusion of patients in the assessment of how the care process is developed (through the patient experience measures) and the results of the care provided (through the outcome measures from the patients' perspective). This approach is being addressed worldwide and is being carried out in various pathologies, such as diabetes and cardiovascular disease, Chronic Obstructive Pulmonary Disease, asthma, etc.

Although the Ecuadorian Health System has undergone a transformation since 2008 with the new constitution and the existing political reform, it has not yet achieved all of its objectives. Despite the significant increase in the number of medical consultations, this is not sufficient as it has not been possible to reflect a real impact on the population. Currently, health systems are aware that it is no longer enough to obtain clinical and administrative data to obtain better clinical results and increase the health of a population, but that they are turning their attention particularly to incorporating the perspective and experience of patients when evaluating the incorporation of changes in the care process. This new focus on patient-centered care is forcing health systems to incorporate new measures to assess the patient's experience through PREMs (Patient Reported Experience Measures) and the results of this care from the patient's perspective through PROMs (Patient Reported Outcome Measure). Thus, at the international level, this type of tool is being developed more and more, and is even being considered in consensus at the international level, a task headed by the International Consortium of Health Outcomes Measures.

In this way, through the development and elaboration, from the perspectives of patients and professionals in the field, tools will be obtained that will allow for adding value to the health care provided by the Ministry of Public Health of Ecuador, expanding the indicators that monitor quality, incorporating patient-centered care and consequently improving clinical results through patient activation and satisfaction.

This is a mixed-methods study. A first component that will focus on the design and validation in Ecuador of PREM and PROM tools through a qualitative study. And a second component, consisting of a prospective cohort study for the implementation of the questionnaires obtained during the first phase that will allow the validation of instruments.

Study Design

Study Type:
Observational
Actual Enrollment :
524 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Patient Centered Care in Diabetes in Ecuador: Mixed-methods Study.
Actual Study Start Date :
Aug 1, 2019
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
Sep 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Group 1 - Qualitative phase

4 focus groups and 6 semi-structured interviews.

Group 2 - Quantitative phase

Pilot study of the tools developed from phase 1.

Other: EPD Questionnaire
A 44 items questionnaire (4 point likert scale) was distributed. Included dimensions where: experience with your physician, provision of care, barriers, outcomes of care, symptoms, patient engagement, health literacy and patient empowerment.
Other Names:
  • Experience questionnaire of the Person with Diabetes
  • Outcome Measures

    Primary Outcome Measures

    1. Patient Reported Outcome [6 months]

      Experience questionnaire of the Person with Diabetes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Persons with diabetes

    • Users of the Health National System

    • From rural and urban areas of Ecuador

    Exclusion Criteria:
    • History of ischemic vascular events. (myocardial infarction and stroke)

    • People with neurological or psychiatric pathology that prevents the understanding of the questions.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidad Católica de Santiago de Guayaquil Guayaquil Guayas Ecuador
    2 Miguel Hernández University Elche Alicante Spain 03202
    3 Foundation for the Promotion of Health and Biomedical Research Sant Joan Alicante Spain 03550

    Sponsors and Collaborators

    • Universidad Miguel Hernandez de Elche
    • Universidad Catolica Santiago de Guayaquil
    • Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    Investigators

    • Study Director: Jose J Mira, PhD, Universidad Miguel Hernández de Elche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    José Joaquín Mira, Professor, Universidad Miguel Hernandez de Elche
    ClinicalTrials.gov Identifier:
    NCT04592263
    Other Study ID Numbers:
    • CEISH-19-0041
    First Posted:
    Oct 19, 2020
    Last Update Posted:
    Sep 30, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by José Joaquín Mira, Professor, Universidad Miguel Hernandez de Elche

    Study Results

    No Results Posted as of Sep 30, 2021