Patient SatisfactionNCT04592263
Patient Centered Care in Diabetes in Ecuador
An observational study of Patient Satisfaction and Patient Engagement, run by Universidad Miguel Hernandez de Elche at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction, Patient Engagement, Patient Empowerment
- What is being tested?
- EPD Questionnaire
- How many people
- 524 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Aug 2019to 28 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Setting: Primary Care Centers of Ecuador
Who may be able to join
- Persons with diabetes
- Users of the Health National System
- From rural and urban areas of Ecuador
Who cannot join
- History of ischemic vascular events. (myocardial infarction and stroke)
- People with neurological or psychiatric pathology that prevents the understanding of the questions.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Miguel Hernández University
Elche, Alicante, 03202
Foundation for the Promotion of Health and Biomedical Research
Sant Joan, Alicante, 03550
About this study
Official title: Patient Centered Care in Diabetes in Ecuador: Mixed-methods Study.
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.
Read more
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.
Read the 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.
- Conditions
- Patient Satisfaction, Patient Engagement, Patient Empowerment, Health Literacy, Patient Experience
- Being tested
- EPD Questionnaire
- Keywords
- Patient Reported Measures, Chronic Diseases, Diabetes, Ecuador, Patient Experience, Quality of care
- Medical subject headings
- Patient Satisfaction, Patient Participation, Chronic Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPD QuestionnaireOther
Also called Experience questionnaire of the Person with Diabetes
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: EPD Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcome
Experience questionnaire of the Person with Diabetes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Aug 2019
- Primary completion30 Apr 2021
- Study completion28 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Catolica Santiago de Guayaquil, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Responsible party
- Principal investigator, José Joaquín Mira, Universidad Miguel Hernandez de Elche
- Investigators
- Jose J Mira, PhD, Study director, Universidad Miguel Hernández de Elche.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592263
- Sponsor's protocol ID
- CEISH-19-0041
- Status last verified
- Sep 2021
- First submitted
- 15 Oct 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available upon reasonable request, and prior consultation with the ethics committee.
Publications
OMS. Informe mundial sobre la Diabetes. Organización Mundial de la Salud. 2016.
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.
PubMed 28435422Porter M, Lee TH. The strategy that will fix health care. Harvard Business Review. 2013;94:24.
Shah A. Value-based healthcare: A global assessment. Econ Intell Unit. 2016;32
Canadian Institute for Health Information. Patient-Centred Measurement and Reporting in Canada Launching the Discussion Toward a Future State. 2017;
Ministerio de Salud Publica del Ecuador. Guía de Práctica Clínica (GPC) de Diabetes mellitus tipo 2. 2017;
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.
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.
PubMed 20478753Kinmonth 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.
PubMed 9006224Cinar 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.
PubMed 25614885Deshpande 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.
PubMed 22145124Mira 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.
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.
PubMed 27013595Prieto 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.
PubMed 11996718
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Care in Diabetes in Ecuador: Mixed-methods Study.
- ClinicalTrials.gov ID
- NCT04592263
- Acronym / sponsor ID
- CEISH-19-0041
- Conditions
- Patient Satisfaction, Patient Engagement, Patient Empowerment, Health Literacy, Patient Experience
- Keywords
- Patient Reported Measures, Chronic Diseases, Diabetes, Ecuador, Patient Experience, Quality of care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 524 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Universidad Catolica Santiago de Guayaquil, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Qualitative phase | – | –4 focus groups and 6 semi-structured interviews. |
| Group 2 - Quantitative phase | – | Other: EPD QuestionnairePilot study of the tools developed from phase 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Setting: Primary Care Centers of Ecuador
Key inclusion criteria (3 listed)
- Persons with diabetes
- Users of the Health National System
- From rural and urban areas of Ecuador
Key exclusion criteria (2 listed)
- History of ischemic vascular events. (myocardial infarction and stroke)
- People with neurological or psychiatric pathology that prevents the understanding of the questions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPD QuestionnaireAlso: Experience questionnaire of the Person with DiabetesA 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 | Group 2 - Quantitative phase |
Primary outcome
Patient Reported Outcome
Time frame: 6 months
Experience questionnaire of the Person with Diabetes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- BackgroundOMS. Informe mundial sobre la Diabetes. Organización Mundial de la Salud. 2016.
- Background: PubMed 28435422Mira 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.
- BackgroundPorter M, Lee TH. The strategy that will fix health care. Harvard Business Review. 2013;94:24.
- BackgroundShah A. Value-based healthcare: A global assessment. Econ Intell Unit. 2016;32
- BackgroundCanadian Institute for Health Information. Patient-Centred Measurement and Reporting in Canada Launching the Discussion Toward a Future State. 2017;
- BackgroundMinisterio de Salud Publica del Ecuador. Guía de Práctica Clínica (GPC) de Diabetes mellitus tipo 2. 2017;
- BackgroundFreire 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: PubMed 20478753Barcelo 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.
- Background: PubMed 9006224Kinmonth 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.
- Background: PubMed 25614885Cinar 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.
- Background: PubMed 22145124Deshpande 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.
- BackgroundMira 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.
- Individual participant dataSharing planned: Undecided. Available upon reasonable request, and prior consultation with the ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose J Mira, PhD study director
Universidad Miguel Hernández de Elche.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction and Patient Engagement, run by Universidad Miguel Hernandez de Elche at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04592263, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.