China Hypertension and Diabetes Care Cascade Study

NCT06141278 | Not Yet Recruiting

• 1 other identifier: 2023026
• Study Type: interventional
• Target: 14,400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.To describe the cascade gap and identify barriers and facilitators at each cascade stage.
2. 2.To develop practical interventions through stakeholder co-design.
3. 3.To assess the effectiveness of developed interventions and evaluate implementation strategies.

Conditions

Hypertension; Diabetes

Outcome Measures

Primary Outcomes (3)

• 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

  Baseline and at 12 month

• Change of blood glucose control at baseline and at 12 month

  The proportion of diabetes patients who have achieved HbA1c \< 6.5%

  Baseline and at 12 month

• 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

  Baseline and at 12 month

Secondary Outcomes (3)

• Screening rate at baseline and at 12 month

  Baseline and at 12 month

• Diagnosis rate at baseline and at 12 month

  Baseline and at 12 month

• Treatment rate at baseline and at 12 month

  Baseline and at 12 month

Study Arms (2)

Intervention

EXPERIMENTAL

Stakeholder-based participatory research will be conducted after CFIR-ERIC mapping activities to focus on partnerships, engagement, co-learning, and developing interventions incorporating interventions on existing practices. Three workshops will be held to reach agreements on the intervention tools, the implementation structure, the data collection procedures and the study audit process among the research team, local policymakers, and implementers. The participants and contents of each workshop are shown in Table 1. At the end of the workshop series, the implementation team from each county prepared a proposed intervention plan describing the steps needed to achieve their goals within a set timeline. The agreed plan of action considered their constraints and how to overcome those barriers.

Behavioral: Care cascade intervention

Control

NO INTERVENTION

Usual care

Interventions

Care cascade intervention BEHAVIORAL

Co-designed integrated care based on the Chronic Care Model to improve hypertension and diabetes care cascade

Intervention

Eligibility Criteria

• Age: 35 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent residents of the surveyed village (residing for more than six months each year).
• Age between 35 and 74 years old.

You may not qualify if:

• 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.
• Individuals who are currently away (i.e. hospitalized, or residing elsewhere) so that cannot participate in the survey.

Sponsors & Collaborators

• Peking Union Medical College: lead

Related Publications (1)

• Yin X, Wang Z, Yang J, Li J, Han S, Feng W, Liu Q, Li N, Zhang L, Ke J, Wei X, Zhang J, Sarrafzadegan N, Shao R. Improvement of Care Cascade for Hypertension and Diabetes in Rural China: Protocol for an Implementation Study. J Clin Hypertens (Greenwich). 2024 Dec;26(12):1466-1478. doi: 10.1111/jch.14918. Epub 2024 Nov 4.

  PMID: 39494843 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 21, 2023

Record last verified: 2023-11