Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141278
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-21
First Post:
2023-11-15
Brief Title:
China Hypertension and Diabetes Care Cascade Study
Sponsor:
Peking Union Medical College
Organization:
Peking Union Medical College
Study Overview
Official Title:
China Hypertension and Diabetes Care Cascade Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHICCs
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 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
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
Detailed Description:
Hypertension and type 2 diabetes present substantial challenges to the Chinese health system A nationwide survey revealed a hypertension prevalence of 372 among Chinese adults over 35 with only 447 aware of their diagnosis and a mere 301 receiving antihypertensive treatment resulting in an overall control rate of 72 1 Similarly diabetes prevalence in 2018 stood at 129 with awareness and treatment rates of 37 and 33 respectively 2 Achieving hypertension and diabetes control is conditional on successful progression through screening diagnosis management and control-a continuum demanding care continuity The care cascade analysis originally devised for communicable diseases ie HIV and tuberculosis offers a systematic approach that dissects disease management into a series of interconnected service delivery stages 3 4 This method evaluates patient progression unveiling critical drop-offs between each stage Despite existing population-based surveys detailing the awareness prevalence and treatment of hypertension and diabetes in China few studies provide a systematic diagnosis of what happens between stages and devise interventions tailored to each stage of the care cascade
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
This is a hybrid design implementation study using mixed methods and integrates diverse implementation theories models and frameworks The theoretical model synthesises the process model determinant framework and evaluation framework under the theory of implementation science Figure 1 The Consolidated Framework for Implementation Research CFIR framework identifies multilevel factors influencing implementation The chronic care model CCM is used to inform intervention development The RE-AIM reach effectiveness adoption implementation maintenance framework is used to assess interventions across multiple dimensions Normalisation Process Theory NPT is applied to measure elements critical for successful implementation and integration into routine work
The study will be conducted in Gongyi Wugang and Weifang counties of China Study sites are selected by the study team on the basis of their willingness to participate and their proximity to the research team
This study comprises three phases 1 context analysis and need assessment 2 intervention development and 3 implementation and evaluation
In phase one we will conduct qualitative interviews with policymakers physicians primary care health providers and patients This exploration distill the current state of hypertension and diabetes care in selected counties identifying determinants within health delivery functions The Consolidated Framework for Implementation Research CFIR framework will guide the assessment allowing for a nuanced understanding of the intricacies influencing care cascades
Phase two will employ stakeholder-based participatory research to craft targeted interventions Systematic assessments of barriers identified in phase one will inform this process facilitated by the CFIR-ERIC tool for mapping potential strategies The resultant priority actions and interventions will be collaboratively co-designed with local service providers health administrators and decision-makers ensuring a tailored and contextually relevant approach
In phase three a rigorously designed cluster-randomized controlled trial will be implemented to discern longitudinal changes in hypertension and diabetes care Forty-eight villages will undergo randomisation into intervention and control groups employing a 11 allocation ratio Intervention villages will enact strategies developed in phase two while control villages maintain usual care The intervention period spans one year To assess study outcomes at the population level we will draw two independent random samples comprising 150 participants aged 35 to 74 from each village before and after the intervention Outcomes measured include patient-level clinical outcomes ie between-group differences in SBP HbA1c system-level service outcomes ie successful progression through steps of cascade and implementation outcomes ie reach adoption feasibility fidelity Baseline surveys conducted prior to randomization aim to blind study staff from intervention allocation The follow-up survey performed one year after intervention initiation will involve participants identified in the baseline survey supplemented by the recruitment of an additional random sample Qualitative interviews with stakeholders will be conducted to discern barriers and facilitators encountered during intervention implementation Furthermore an economic evaluation from the health services perspective is planned to provide a comprehensive understanding of the interventions impact on healthcare resource utilisation and cost-effectiveness
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
This is a hybrid design implementation study using mixed methods and integrates diverse implementation theories models and frameworks The theoretical model synthesises the process model determinant framework and evaluation framework under the theory of implementation science Figure 1 The Consolidated Framework for Implementation Research CFIR framework identifies multilevel factors influencing implementation The chronic care model CCM is used to inform intervention development The RE-AIM reach effectiveness adoption implementation maintenance framework is used to assess interventions across multiple dimensions Normalisation Process Theory NPT is applied to measure elements critical for successful implementation and integration into routine work
The study will be conducted in Gongyi Wugang and Weifang counties of China Study sites are selected by the study team on the basis of their willingness to participate and their proximity to the research team
This study comprises three phases 1 context analysis and need assessment 2 intervention development and 3 implementation and evaluation
In phase one we will conduct qualitative interviews with policymakers physicians primary care health providers and patients This exploration distill the current state of hypertension and diabetes care in selected counties identifying determinants within health delivery functions The Consolidated Framework for Implementation Research CFIR framework will guide the assessment allowing for a nuanced understanding of the intricacies influencing care cascades
Phase two will employ stakeholder-based participatory research to craft targeted interventions Systematic assessments of barriers identified in phase one will inform this process facilitated by the CFIR-ERIC tool for mapping potential strategies The resultant priority actions and interventions will be collaboratively co-designed with local service providers health administrators and decision-makers ensuring a tailored and contextually relevant approach
In phase three a rigorously designed cluster-randomized controlled trial will be implemented to discern longitudinal changes in hypertension and diabetes care Forty-eight villages will undergo randomisation into intervention and control groups employing a 11 allocation ratio Intervention villages will enact strategies developed in phase two while control villages maintain usual care The intervention period spans one year To assess study outcomes at the population level we will draw two independent random samples comprising 150 participants aged 35 to 74 from each village before and after the intervention Outcomes measured include patient-level clinical outcomes ie between-group differences in SBP HbA1c system-level service outcomes ie successful progression through steps of cascade and implementation outcomes ie reach adoption feasibility fidelity Baseline surveys conducted prior to randomization aim to blind study staff from intervention allocation The follow-up survey performed one year after intervention initiation will involve participants identified in the baseline survey supplemented by the recruitment of an additional random sample Qualitative interviews with stakeholders will be conducted to discern barriers and facilitators encountered during intervention implementation Furthermore an economic evaluation from the health services perspective is planned to provide a comprehensive understanding of the interventions impact on healthcare resource utilisation and cost-effectiveness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None