Patient Centered Care in Diabetes in Ecuador

NCT04592263 | Completed

• 1 other identifier: CEISH-19-0041
• Study Type: observational
• Target: 524
• Locations: 2 countries
• Sites: 3

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.

Conditions

Patient Satisfaction; Patient Engagement; Patient Empowerment; Health Literacy; Patient Experience

Keywords

Patient Reported Measures; Chronic Diseases; Diabetes; Ecuador; Patient Experience; Quality of care

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcome

  Experience questionnaire of the Person with Diabetes

  6 months

Study Arms (2)

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

Interventions

EPD Questionnaire OTHER

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.

Also known as: Experience questionnaire of the Person with Diabetes

Group 2 - Quantitative phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Setting: Primary Care Centers of Ecuador

You may qualify if:

• Persons with diabetes
• Users of the Health National System
• From rural and urban areas of Ecuador

You may not qualify if:

• History of ischemic vascular events. (myocardial infarction and stroke)
• People with neurological or psychiatric pathology that prevents the understanding of the questions.

Sponsors & Collaborators

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

Study Sites (3)

Universidad Católica de Santiago de Guayaquil

Guayaquil, Guayas, Ecuador

Location

Miguel Hernández University

Elche, Alicante, 03202, Spain

Location

Foundation for the Promotion of Health and Biomedical Research

Sant Joan, Alicante, 03550, Spain

Location

Related Publications (14)

• OMS. Informe mundial sobre la Diabetes. Organización Mundial de la Salud. 2016.

  BACKGROUND

• Mira JJ, Nuno-Solinis R, Guilabert-Mora M, Solas-Gaspar O, Fernandez-Cano P, Gonzalez-Mestre MA, Contel JC, Del Rio-Camara M. Development and Validation of an Instrument for Assessing Patient Experience of Chronic Illness Care. Int J Integr Care. 2016 Aug 31;16(3):13. doi: 10.5334/ijic.2443.

  PMID: 28435422 BACKGROUND

• Porter M, Lee TH. The strategy that will fix health care. Harvard Business Review. 2013;94:24.

  BACKGROUND

• Shah A. Value-based healthcare: A global assessment. Econ Intell Unit. 2016;32

  BACKGROUND

• Canadian Institute for Health Information. Patient-Centred Measurement and Reporting in Canada Launching the Discussion Toward a Future State. 2017;

  BACKGROUND

• Ministerio de Salud Publica del Ecuador. Guía de Práctica Clínica (GPC) de Diabetes mellitus tipo 2. 2017;

  BACKGROUND

• Freire W, Ramirez-Luzuriaga MJ, Belmont P, Mendieta MJ, Silva-Jaramillo K, Romero N, et al. Tomo I: Encuesta Nacional de Salud y Nutrición ENSANUT - ECU 2012. primera ed. Quito: Ministerio de Salud Pública/Instituto Nacional de Estadísticas y Censos; 2014.

  BACKGROUND

• Barcelo A, Cafiero E, de Boer M, Mesa AE, Lopez MG, Jimenez RA, Esqueda AL, Martinez JA, Holguin EM, Meiners M, Bonfil GM, Ramirez SN, Flores EP, Robles S. Using collaborative learning to improve diabetes care and outcomes: the VIDA project. Prim Care Diabetes. 2010 Oct;4(3):145-53. doi: 10.1016/j.pcd.2010.04.005. Epub 2010 May 15.

  PMID: 20478753 BACKGROUND

• Kinmonth AL, Spiegal N, Woodcock A. Developing a training programme in patient-centred consulting for evaluation in a randomised controlled trial; diabetes care from diagnosis in British primary care. Patient Educ Couns. 1996 Oct;29(1):75-86. doi: 10.1016/0738-3991(96)00936-6.

  PMID: 9006224 BACKGROUND

• Cinar AB, Schou L. Interrelation between patient satisfaction and patient-provider communication in diabetes management. ScientificWorldJournal. 2014;2014:372671. doi: 10.1155/2014/372671. Epub 2014 Dec 28.

  PMID: 25614885 BACKGROUND

• Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: A new era in clinical research. Perspect Clin Res. 2011 Oct;2(4):137-44. doi: 10.4103/2229-3485.86879.

  PMID: 22145124 BACKGROUND

• Mira Solves JJ, Guilabert M, Pérez-Jover V. La medida de la experiencia del paciente en el contexto de una atención centrada en el propio paciente. Rev Española Med Prev y Salud Pública. 2018;XXIII:5-11.

  BACKGROUND

• Svedbo Engstrom M, Leksell J, Johansson UB, Gudbjornsdottir S. What is important for you? A qualitative interview study of living with diabetes and experiences of diabetes care to establish a basis for a tailored Patient-Reported Outcome Measure for the Swedish National Diabetes Register. BMJ Open. 2016 Mar 24;6(3):e010249. doi: 10.1136/bmjopen-2015-010249.

  PMID: 27013595 BACKGROUND

• Prieto Rodriguez MA, March Cerda JC. [Step by step in the design of a focus group-based study]. Aten Primaria. 2002 Apr 15;29(6):366-73. doi: 10.1016/s0212-6567(02)70585-4. No abstract available. Spanish.

  PMID: 11996718 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Patient Participation; Chronic Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Patient Acceptance of Health Care; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jose J Mira, PhD

  Universidad Miguel Hernández de Elche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 19, 2020
• Study Start: August 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: September 28, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

EC (1); ES (2)