China Hypertension and Diabetes Care Cascade Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-74
SponsorPeking Union Medical College
About this trial
This implementation study aims to identify priorities and formulate strategies to overcome health service delivery bottlenecks associated with hypertension and diabetes in rural China. Leveraging implementation frameworks, the study seeks to unravel the complexities embedded within the care cascade, paving the way for targeted interventions. Addressing the nuanced dynamics of the care cascade, this research will provide indispensable insights for optimising healthcare delivery in resource-limited settings, ultimately informing global perspectives on chronic disease management.
The overall aim of this study is to enhance the control of hypertension and diabetes in rural China through a systematic assessment and improvement of the care cascade, specifically:
1. To describe the cascade gap and identify barriers and facilitators at each cascade stage. 2. To develop practical interventions through stakeholder co-design. 3. To assess the effectiveness of developed interventions and evaluate implementation strategies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Permanent residents of the surveyed village (residing for more than six months each year).
Age between 35 and 74 years old.
Disqualifiers
Individuals with severe mental disorders or communication barriers.
Individuals planning to move out of the village within the next year.
Expected life expectancy of less than one year.
Pregnant or lactating individuals.
Trial design
Design model
Parallel
Treatments tested in this trial
Care cascade intervention
BehavioralCo-designed integrated care based on the Chronic Care Model to improve hypertension and diabetes care cascade
Treatment groups
14,400 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change of blood pressure control at baseline and at 12 month
The proportion of hypertension patients who have achieved BP control. We defined control as BP \< 140/90 mmHg or lower in complex cases, such as diabetes
Time frame
Baseline and at 12 month2
Change of blood glucose control at baseline and at 12 month
The proportion of diabetes patients who have achieved HbA1c \< 6.5%
Time frame
Baseline and at 12 month3
Change of SBP at baseline and at 12 month
Blood pressure is measured after the participant has rested for at least 15 minutes. Blood pressure is measured at least three times at 3 minutes intervals using the appropriate cuff size and a Digital Automatic Blood Pressure Monitor
Time frame
Baseline and at 12 monthSecondary outcomes
1
Screening rate at baseline and at 12 month
Percent of population with high blood pressure who have had previously had blood pressure measured according to standards. And percent of population with Diabetes who have ever had a blood glucose test.
Time frame
Baseline and at 12 month2
Diagnosis rate at baseline and at 12 month
1. The proportion of people with hypertension in the catchment area of interest who are diagnosed at the facility level, where a diagnosis of hypertension follows at least three measurements of BP on two or more health visits with a systolic BP of 140 mmHg or higher or a diastolic BP of 90 mmHg or higher. 2. The proportion of people with diabetes in the catchment area of interest who have a fasting plasma glucose of 7.0 mmol/l (126 mg/dl) or higher, or have a random plasma glucose of 11.1 mmol/l (200 mg/dl) or higher, or have an HbA1c measurement of 6.5% or higher
Time frame
Baseline and at 12 month3
Treatment rate at baseline and at 12 month
1. The proportion of people who initiate treatment for hypertension, remain in care, and are followed-up by their service provider. A patient was considered being monitored by the care provider if there was evidence of BP being measured and recorded every month. 2. The proportion of people who initiate treatment for diabetes, remain in care, and are followed-up by their service provider. A patient was considered being monitored by the care provider if there was evidence of blood glucose being measured and recorded every 3 months.
Time frame
Baseline and at 12 monthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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