Contextualizing Evidence for Action on Diabetes in Low-resource Settings: a Mixed-methods Case Study in Quito and Esmeraldas, Ecuador.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,152
- 试验地点
- 1
- 主要终点
- Proportion of patients with biochemically controlled disease
研究概览
简要总结
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.
详细描述
Objective: To evaluate the implementation of comprehensive diabetes care in two low-resource settings in Ecuador.
Specific objectives:
- To assess patient outcomes including biochemical diabetes control and health-related quality of life.
- To evaluate diabetes-related health care access.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unability to provide informed consent (e.g. significant mental impairment).
- •Pregnant women if they are diagnosed with gestational diabetes.
结局指标
主要结局
Proportion of patients with biochemically controlled disease
时间窗: Year 4
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.
Proportion of patients with optimal health-related quality of life
时间窗: Year 4
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.
Proportion of patients with access to health care of diabetes
时间窗: Year 4
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.
次要结局
- Number of hospitalisations due to diabetes complications(Year 4)
- Proportion of patients who diabetes-related education received(Year 4)
- Proportion of patients with blood pressure controlled (<140/90 mmHg)(Year 4)
- Perceived social support(Year 4)
- Proportion of patients with BMI between 18.5 and 25 kg/m2 or 5% weight loss if BMI>25 kg/m2(Year 4)
- Proportion of patients with LDL cholesterol level < 100 mg/dl(Year 4)
- Proportion of patients with microalbuminuria level <30 mg/day(Year 4)
- Number of unscheduled diabetes-related consultations(Year 4)
- Proportion of patients with at least one disease complication(Year 4)
研究者
Lucy Anne Parker
Lecturer
Universidad Miguel Hernandez de Elche