Clinical trial NCT04560062: Contextualizing the Evidence for Action on Diabetes - Cohort
Official title: Contextualizing Evidence for Action on Diabetes in Low-resource Settings: a Mixed-methods Case Study in Quito and Esmeraldas, Ecuador.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Keywords: Implementation science
Delivery of Health Care
Public Policy
Non-communicable Disease
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: European Research Council
name: Pontificia Universidad Católica del Ecuador
name: Centro de Epidemiología Comunitaria y Medicina Tropical
First posted: 2020-09-23
Enrollment: 1152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The CEAD project will be carried out in 2 low-resource settings in Ecuador: 1) District 17D06, South Quito, an urban health district ; and 2) District 08D02, Eloy Alfaro District, in Esmeraldas Province, a rural area in the northern coastal region of the country.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with biochemically controlled disease
timeFrame: Year 1
measure: Proportion of patients with biochemically controlled disease
timeFrame: Year 2
measure: Proportion of patients with biochemically controlled disease
timeFrame: Year 3
measure: Proportion of patients with biochemically controlled disease
timeFrame: Year 4
measure: Proportion of patients with optimal health-related quality of life
timeFrame: Year 3
measure: Proportion of patients with optimal health-related quality of life
timeFrame: Year 4
measure: Proportion of patients with access to health care of diabetes
timeFrame: Year 1
measure: Proportion of patients with access to health care of diabetes
timeFrame: Year 2
measure: Proportion of patients with access to health care of diabetes
timeFrame: Year 3
measure: Proportion of patients with access to health care of diabetes
timeFrame: Year 4
Secondary outcomes:
measure: Perceived social support
timeFrame: Year 3
measure: Perceived social support
timeFrame: Year 4
measure: Proportion of patients who diabetes-related education received
timeFrame: Year 3
measure: Proportion of patients who diabetes-related education received
timeFrame: Year 4
measure: Proportion of patients with blood pressure controlled (<140/90 mmHg)
timeFrame: Year 1
measure: Proportion of patients with blood pressure controlled (<140/90 mmHg)
timeFrame: Year 2
measure: Proportion of patients with blood pressure controlled (<140/90 mmHg)
timeFrame: Year 3
measure: Proportion of patients with blood pressure controlled (<140/90 mmHg)
timeFrame: Year 4
measure: Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
timeFrame: Year 1
measure: Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
timeFrame: Year 2
measure: Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
timeFrame: Year 3
measure: Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2
timeFrame: Year 4
measure: Proportion of patients with LDL cholesterol level < 100 mg/dl
timeFrame: Year 1
measure: Proportion of patients with LDL cholesterol level < 100 mg/dl
timeFrame: Year 2
measure: Proportion of patients with LDL cholesterol level < 100 mg/dl
timeFrame: Year 3
measure: Proportion of patients with LDL cholesterol level < 100 mg/dl
timeFrame: Year 4
measure: Proportion of patients with microalbuminuria level <30 mg/day
timeFrame: Year 1
measure: Proportion of patients with microalbuminuria level <30 mg/day
timeFrame: Year 2
measure: Proportion of patients with microalbuminuria level <30 mg/day
timeFrame: Year 3
measure: Proportion of patients with microalbuminuria level <30 mg/day
timeFrame: Year 4
measure: Number of unscheduled diabetes-related consultations
timeFrame: Year 1
measure: Number of unscheduled diabetes-related consultations
timeFrame: Year 2
measure: Number of unscheduled diabetes-related consultations
timeFrame: Year 3
measure: Number of unscheduled diabetes-related consultations
timeFrame: Year 4
measure: Number of hospitalisations due to diabetes complications
timeFrame: Year 1
measure: Number of hospitalisations due to diabetes complications
timeFrame: Year 2
measure: Number of hospitalisations due to diabetes complications
timeFrame: Year 3
measure: Number of hospitalisations due to diabetes complications
timeFrame: Year 4
measure: Proportion of patients with at least one disease complication
timeFrame: Year 1
measure: Proportion of patients with at least one disease complication
timeFrame: Year 2
measure: Proportion of patients with at least one disease complication
timeFrame: Year 3
measure: Proportion of patients with at least one disease complication
timeFrame: Year 4
Other outcomes:
Locations:
city: Esmeraldas
country: Ecuador
facility: Mari Carmen Bernal Soriano
Study officials:
affiliation: University Miguel Hernández
name: Lucy A Parker, PhD
role: PRINCIPAL_INVESTIGATOR
References: