Contextualizing the Evidence for Action on Diabetes - Cohort

Diabetes Mellitus, Type 2 Clinical Trial

— CEAD  

Official title:

Contextualizing Evidence for Action on Diabetes in Low-resource Settings: a Mixed-methods Case Study in Quito and Esmeraldas, Ecuador.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560062
• Other study ID #: ERC-2018-STG-804761.2
• Status: Recruiting
• Start date: October 13, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2021
• Source: Universidad Miguel Hernandez de Elche
• Contact: Lucy Anne Parker
• Phone: +34 965919516
• Email: lparker[@]umh.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This protocol reflects the second part of a larger mixed-methods study aimed at exploring the process by which global recommendations can be translated into context-specific, evidence-informed action for diabetes prevention in low-resource settings. Firstly, a retrospective cohort study will assess the current level of implementation of comprehensive diabetes care over a 24-month period (2019-2020), by describing healthcare received and health outcomes of a representative sample of diabetes patients currently accessing care in the study region. Focus groups prompted by the findings of the retrospective study will be used to inspire local innovations which will be evaluated through a prospective follow-up of the cohort.

Description:

Objective: To evaluate the implementation of comprehensive diabetes care in two low-resource settings in Ecuador. Specific objectives: 1. To assess patient outcomes including biochemical diabetes control and health-related quality of life. 2. To evaluate diabetes-related health care access. 3. To assess complications related to diabetes. Sample size: The sample size is proposed conservatively to ensure a precision to estimate outcomes of 50% with an absolute precision of ±5%, assuming a design effect of 1.2 and potential loss of 20%. Sample design: A representative sample for each district will be obtained by stratified single-stage cluster sampling. The clusters are health facilities for which a sample of patients will randomly selected. The sample will be stratified by facility type (Ministry of Public Health (MSP) facilities, or Social Security facilities for affiliated workers) in Quito and by Rural/Urban setting in Esmeraldas. Patient sampling will use the electronic consultation registry of each selected facility where possible. Data unavailable in the electronic registers will be extracted from any available paper files. Data collection procedure: Research assistants will obtain the data mainly from health services records, which will be supplemented by patient interviews including socio-demographic and clinical data, perceived social support (the Multidimensional Scale of Perceived Social Support, MSPSS) and health-related quality of life (the Diabetes Health Profile-18, DHP-18) profile. They will collect data regarding whether the patient received regular review by a clinician, and underwent screening for diabetes complications as recommended in the 2017 Clinical Practice Guideline for Type 2 Diabetes in Ecuador. He/she will record the date and details of any complications and experiences over the course of the evaluation and other clinical data such as comorbidities, treatments or patient management by a multidisciplinary health care team. The first data collection will be retrospective and will include diabetes-related health care and clinical outcomes during 2019 and 2020. Clinical files will be reviewed every 12 months for the duration of follow-up (2 years). Supplementary interview data will be assessed on a baseline and in the last 6 months of follow-up. Analysis: The researchers will calculate the proportion of patients that received care as per the clinical practice guideline (CPG) recommendations and/or the proportion receiving an intermediate level of care (as required). Proportions will be described with 95% confidence intervals. Variation in healthcare received and diabetes-related health will be described using sociodemographic and clinical characteristics of the patients to highlight potential inequities. A multivariate logistic regression model may be used to explore the relationship between the primary outcomes and socioeconomic explanatory variable and/or type of health facility. If necessary, the researchers will adjust for potential confounders such as patients' factors (e.g. sex, age, comorbidity, perceived social support) and/or environmental factors (e.g. proximity to the health centre, availability of different medical specialties or methods as laboratory test). Statistical analysis will be performed using Stata/SE (StataCorp, College Station, TX, USA) Version 15.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1152
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals diagnosed with type-2 diabetes.
• Age over 18 years.
• Patients are accessing diabetes care in health facilities in the study districts.
• Providing informed consent

Exclusion Criteria:

• Unability to provide informed consent (e.g. significant mental impairment).
• Pregnant women if they are diagnosed with gestational diabetes.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Spontaneous changes in diabetes-related health care
The findings of a retrospective cohort analysis conducted in the initial phase of the study will be used in focus groups to identify observed weaknesses in local health systems and will promote possible solutions to strengthen diabetes-related health care. Every focus group will include community members, healthcare workers, decision-makers and diabetic patients and family members.

Locations

Country	Name	City	State
Ecuador	Mari Carmen Bernal Soriano	Esmeraldas

Sponsors (4)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Centro de Epidemiología Comunitaria y Medicina Tropical, European Research Council, Pontificia Universidad Católica del Ecuador

Country where clinical trial is conducted

Ecuador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with biochemically controlled disease	Proportions of patients with controlled disease along with 95% confidence interval.; Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if =15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.	Year 1
Primary	Proportion of patients with biochemically controlled disease	Proportions of patients with controlled disease along with 95% confidence interval.; Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if =15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.	Year 2
Primary	Proportion of patients with biochemically controlled disease	Proportions of patients with controlled disease along with 95% confidence interval.; Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if =15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.	Year 3
Primary	Proportion of patients with biochemically controlled disease	Proportions of patients with controlled disease along with 95% confidence interval.; Controlled disease is defined according to the last laboratory result as glycated haemoglobin <7% or <8% if =15 years of evolution or complications and serious comorbidities; or fasting blood glucose: 70 - 130 mg/dl or postprandial blood glucose <180 mg/dl.	Year 4
Primary	Proportion of patients with optimal health-related quality of life	Health-related quality of life will be obtained with Diabetes Health Profile-18 (DHP-18) questionnaire. DHP-18 scores range from 0 to 100, with 0 representing no dysfunction and 100 maximum dysfunction.; Proportion of patients with total final score under the median, meaning lower dysfunction, along with 95% confidence interval.	Year 3
Primary	Proportion of patients with optimal health-related quality of life	Health-related quality of life will be obtained with Diabetes Health Profile-18 (DHP-18) questionnaire. DHP-18 scores range from 0 to 100, with 0 representing no dysfunction and 100 maximum dysfunction.; Proportion of patients with total final score under the median, meaning lower dysfunction, along with 95% confidence interval.	Year 4
Primary	Proportion of patients with access to health care of diabetes	It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.	Year 1
Primary	Proportion of patients with access to health care of diabetes	It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.	Year 2
Primary	Proportion of patients with access to health care of diabetes	It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.	Year 3
Primary	Proportion of patients with access to health care of diabetes	It includes processes of care indicators that represent the proportion of the patients who undergo the care processes recommended by the CPG to manage the disease. The investigators will obtain the care frequency for each patient during the year of study as a quantitative value and will also categorize those care indicators that are recommended with greater periodicity in the CPG.	Year 4
Secondary	Perceived social support	Results of the standardized questionnaire "the Multidimensional Scale of Perceived Social Support (MSPSS)". The response format is a four-point Likert type scale (1= rarely, 2= sometimes, 3=frequently, 4= always or almost always). A higher score implies a greater perception of social support.; Tertiles of total final score will be used to measure low, medium and high social support. The investigators will report the patient ratio and 95% confidence interval for each category of social support	Year 3
Secondary	Perceived social support	Results of the standardized questionnaire "the Multidimensional Scale of Perceived Social Support (MSPSS)". The response format is a four-point Likert type scale (1= rarely, 2= sometimes, 3=frequently, 4= always or almost always). A higher score implies a greater perception of social support.; Tertiles of total final score will be used to measure low, medium and high social support. The investigators will report the patient ratio and 95% confidence interval for each category of social support.	Year 4
Secondary	Proportion of patients who diabetes-related education received	Self-reported information [dichotomous (yes/no) responses]. Proportion of patients who indicate that they have received information on diabetes and healthy habits, along with 95% confidence interval.	Year 3
Secondary	Proportion of patients who diabetes-related education received	Self-reported information [dichotomous (yes/no) responses]. Proportion of patients who indicate that they have received information on diabetes and healthy habits, along with 95% confidence interval.	Year 4
Secondary	Proportion of patients with blood pressure controlled (<140/90 mmHg)	Proportions along with 95% confidence interval.	Year 1
Secondary	Proportion of patients with blood pressure controlled (<140/90 mmHg)	Proportions along with 95% confidence interval.	Year 2
Secondary	Proportion of patients with blood pressure controlled (<140/90 mmHg)	Proportions along with 95% confidence interval.	Year 3
Secondary	Proportion of patients with blood pressure controlled (<140/90 mmHg)	Proportions along with 95% confidence interval.	Year 4
Secondary	Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2	Proportions along with 95% confidence interval.	Year 1
Secondary	Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2	Proportions along with 95% confidence interval.	Year 2
Secondary	Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2	Proportions along with 95% confidence interval.	Year 3
Secondary	Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2	Proportions along with 95% confidence interval.	Year 4
Secondary	Proportion of patients with LDL cholesterol level < 100 mg/dl	Proportions along with 95% confidence interval.	Year 1
Secondary	Proportion of patients with LDL cholesterol level < 100 mg/dl	Proportions along with 95% confidence interval.	Year 2
Secondary	Proportion of patients with LDL cholesterol level < 100 mg/dl	Proportions along with 95% confidence interval.	Year 3
Secondary	Proportion of patients with LDL cholesterol level < 100 mg/dl	Proportions along with 95% confidence interval.	Year 4
Secondary	Proportion of patients with microalbuminuria level <30 mg/day	Proportions along with 95% confidence interval.	Year 1
Secondary	Proportion of patients with microalbuminuria level <30 mg/day	Proportions along with 95% confidence interval.	Year 2
Secondary	Proportion of patients with microalbuminuria level <30 mg/day	Proportions along with 95% confidence interval.	Year 3
Secondary	Proportion of patients with microalbuminuria level <30 mg/day	Proportions along with 95% confidence interval.	Year 4
Secondary	Number of unscheduled diabetes-related consultations	Number of unscheduled due to decompensation of the disease and/or complications. Results will be reported as absolute values.	Year 1
Secondary	Number of unscheduled diabetes-related consultations	Number of unscheduled due to decompensation of the disease and/or complications. Results will be reported as absolute values.	Year 2
Secondary	Number of unscheduled diabetes-related consultations	Number of unscheduled due to decompensation of the disease and/or complications. Results will be reported as absolute values.	Year 3
Secondary	Number of unscheduled diabetes-related consultations	Number of unscheduled due to decompensation of the disease and/or complications. Results will be reported as absolute values.	Year 4
Secondary	Number of hospitalisations due to diabetes complications	Number of hospitalisations owing to decompensation of the disease and/or complications. Results will be reported as absolute values.	Year 1
Secondary	Number of hospitalisations due to diabetes complications	Number of hospitalisations owing to decompensation of the disease and/or complications. Results will be reported as absolute values.	Year 2
Secondary	Number of hospitalisations due to diabetes complications	Number of hospitalisations owing to decompensation of the disease and/or complications. Results will be reported as absolute values.	Year 3
Secondary	Number of hospitalisations due to diabetes complications	Number of hospitalisations owing to decompensation of the disease and/or complications. Results will be reported as absolute values.	Year 4
Secondary	Proportion of patients with at least one disease complication	Disease complications considered will include retinopathy and/or blindness, lower limb amputations, cardiovascular events (such as stroke, myocardial infarction, ischemic heart disease, obstructive artery disease, congestive heart failure) and/or renal dysfunction according to the last glomerular filtration rate result using the MDRD-4 (Modification of Diet in Renal Disease) formula or serum creatinine value.; Proportion along with 95% confidence interval.	Year 1
Secondary	Proportion of patients with at least one disease complication	Disease complications considered will include retinopathy and/or blindness, lower limb amputations, cardiovascular events (such as stroke, myocardial infarction, ischemic heart disease, obstructive artery disease, congestive heart failure) and/or renal dysfunction according to the last glomerular filtration rate result using the MDRD-4 (Modification of Diet in Renal Disease) formula or serum creatinine value.; Proportion along with 95% confidence interval.	Year 2
Secondary	Proportion of patients with at least one disease complication	Disease complications considered will include retinopathy and/or blindness, lower limb amputations, cardiovascular events (such as stroke, myocardial infarction, ischemic heart disease, obstructive artery disease, congestive heart failure) and/or renal dysfunction according to the last glomerular filtration rate result using the MDRD-4 (Modification of Diet in Renal Disease) formula or serum creatinine value.; Proportion along with 95% confidence interval.	Year 3
Secondary	Proportion of patients with at least one disease complication	Disease complications considered will include retinopathy and/or blindness, lower limb amputations, cardiovascular events (such as stroke, myocardial infarction, ischemic heart disease, obstructive artery disease, congestive heart failure) and/or renal dysfunction according to the last glomerular filtration rate result using the MDRD-4 (Modification of Diet in Renal Disease) formula or serum creatinine value.; Proportion along with 95% confidence interval.	Year 4