Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trial
Abstract Background Hypertension is the most common cardiovascular disease in Peru despite the availability of cost-effective, evidence-based treatment. Here we describe the rationale and study design for a hybrid type 2 randomized controlled trial to test the implementation and effectiveness of a c...
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2024-11-01
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| author | Lindsay J. Underhill Kendra N. Williams Lucy Cordova-Ascona Karina Campos Lisa de las Fuentes Mark D. Huffman Joel Gittelsohn Kenneth B. Schechtman Zoila Vela-Clavo Carla Tarazona-Meza Laura K. Beres Parker K. Acevedo Abigail Barker Nishadi Rajapakse Makeda Williams Veronica Tonwe Aaloke Mody Raquel Hurtado Juan Carlos Mendoza Gonzalo Cuentas Elvin H. Geng William Checkley Victor G. Dávila-Román Stella M. Hartinger-Peña |
| author_facet | Lindsay J. Underhill Kendra N. Williams Lucy Cordova-Ascona Karina Campos Lisa de las Fuentes Mark D. Huffman Joel Gittelsohn Kenneth B. Schechtman Zoila Vela-Clavo Carla Tarazona-Meza Laura K. Beres Parker K. Acevedo Abigail Barker Nishadi Rajapakse Makeda Williams Veronica Tonwe Aaloke Mody Raquel Hurtado Juan Carlos Mendoza Gonzalo Cuentas Elvin H. Geng William Checkley Victor G. Dávila-Román Stella M. Hartinger-Peña |
| author_sort | Lindsay J. Underhill |
| collection | DOAJ |
| description | Abstract Background Hypertension is the most common cardiovascular disease in Peru despite the availability of cost-effective, evidence-based treatment. Here we describe the rationale and study design for a hybrid type 2 randomized controlled trial to test the implementation and effectiveness of a community health worker (CHW)-led hypertension control program within the national primary care system in Puno, Peru. Methods We will recruit 1068 adult participants with hypertension aged ≥ 18 years in Puno, Peru, via facility-based enrollment and community health fairs. Participants will be individually randomized (1:1) to either continue with usual care or participate in a 12-month CHW-led home-based hypertension control program consisting of blood pressure monitoring, medication adherence support, and healthy lifestyle counseling. Outcome development and reporting are guided by the Consolidated Framework for Implementation Research (CFIR), the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, and the Proctor et al. framework. Clinical effectiveness outcomes include mean change in systolic blood pressure (primary outcome), diastolic blood pressure, and HbA1C. Implementation outcomes include fidelity (i.e., CHW protocol adherence and dose), reach, adoption, sustainability, acceptability, and cost-effectiveness. Discussion The ANDES trial is testing the first CHW-led multicomponent strategy for hypertension and type 2 diabetes management in Peru. This type 2 hybrid trial will provide critical insights into the individual, community, and system-level factors necessary for successful implementation and effectiveness. These data can inform the future adaptation and scaling of the ANDES strategy in Peru and other LMICs, as well as influence policies at the system level to support this transition. Furthermore, by addressing both hypertension and diabetes, the ANDES strategy supports integrated care approaches advocated by the WHO HEARTS technical package, ultimately enhancing health outcomes and reducing morbidity and mortality in the region. Trial registration ClinicalTrials.gov, ID: NCT05524987 , Addressing Hypertension and Diabetes through Community-Engaged Systems in Puno, Peru (ANDES study), prospectively registered on September 1, 2021. |
| format | Article |
| id | doaj-art-ff61ad5458c643e7a775e3e24addd2a4 |
| institution | DOAJ |
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| language | English |
| publishDate | 2024-11-01 |
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| spelling | doaj-art-ff61ad5458c643e7a775e3e24addd2a42025-08-20T02:50:02ZengBMCTrials1745-62152024-11-0125111610.1186/s13063-024-08586-9Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trialLindsay J. Underhill0Kendra N. Williams1Lucy Cordova-Ascona2Karina Campos3Lisa de las Fuentes4Mark D. Huffman5Joel Gittelsohn6Kenneth B. Schechtman7Zoila Vela-Clavo8Carla Tarazona-Meza9Laura K. Beres10Parker K. Acevedo11Abigail Barker12Nishadi Rajapakse13Makeda Williams14Veronica Tonwe15Aaloke Mody16Raquel Hurtado17Juan Carlos Mendoza18Gonzalo Cuentas19Elvin H. Geng20William Checkley21Victor G. Dávila-Román22Stella M. Hartinger-Peña23Global Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, Washington University in St. LouisCenter for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins UniversityFacultad de Salud Pública y Administración, Universidad Peruana Cayetano HerediaFacultad de Salud Pública y Administración, Universidad Peruana Cayetano HerediaGlobal Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, Washington University in St. LouisGlobal Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, Washington University in St. LouisDepartment of International Health, Bloomberg School of Public Health, Johns Hopkins UniversityCenter for Biostatistics and Data Science, Institute for Informatics, Data Science, and Biostatistics (I2BD), School of Medicine, Washington UniversityFacultad de Salud Pública y Administración, Universidad Peruana Cayetano HerediaCenter for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins UniversityDepartment of International Health, Bloomberg School of Public Health, Johns Hopkins UniversityCenter for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins UniversityCenter for Advancing Health Services, Policy, & Economics Research, Washington University in St. LouisNational Institute of Diabetes and Digestive and Kidney Diseases, Division of Diabetes, Endocrinology and Metabolic Diseases, National Institutes of HealthCenter for Translation Research and Implementation Science, National Heart, Lung and Blood Institute (NHLBI), NIHCenter for Translation Research and Implementation Science, National Heart, Lung and Blood Institute (NHLBI), NIHInfectious Diseases Division, Department of Medicine and Dissemination and Implementation Center, Institute for Public Health, Washington University in St. LouisDirección General de Intervenciones Estratégicas en Salud Pública, Ministerio de Salud del PeruPrograma Presupuestal de Enfermedades No TransmisiblesDirección Regional de SaludHospital Base IIIInfectious Diseases Division, Department of Medicine and Dissemination and Implementation Center, Institute for Public Health, Washington University in St. LouisPulmonary and Critical Care Medicine Division, Johns Hopkins University School of MedicineGlobal Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, Washington University in St. LouisFacultad de Salud Pública y Administración, Universidad Peruana Cayetano HerediaAbstract Background Hypertension is the most common cardiovascular disease in Peru despite the availability of cost-effective, evidence-based treatment. Here we describe the rationale and study design for a hybrid type 2 randomized controlled trial to test the implementation and effectiveness of a community health worker (CHW)-led hypertension control program within the national primary care system in Puno, Peru. Methods We will recruit 1068 adult participants with hypertension aged ≥ 18 years in Puno, Peru, via facility-based enrollment and community health fairs. Participants will be individually randomized (1:1) to either continue with usual care or participate in a 12-month CHW-led home-based hypertension control program consisting of blood pressure monitoring, medication adherence support, and healthy lifestyle counseling. Outcome development and reporting are guided by the Consolidated Framework for Implementation Research (CFIR), the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, and the Proctor et al. framework. Clinical effectiveness outcomes include mean change in systolic blood pressure (primary outcome), diastolic blood pressure, and HbA1C. Implementation outcomes include fidelity (i.e., CHW protocol adherence and dose), reach, adoption, sustainability, acceptability, and cost-effectiveness. Discussion The ANDES trial is testing the first CHW-led multicomponent strategy for hypertension and type 2 diabetes management in Peru. This type 2 hybrid trial will provide critical insights into the individual, community, and system-level factors necessary for successful implementation and effectiveness. These data can inform the future adaptation and scaling of the ANDES strategy in Peru and other LMICs, as well as influence policies at the system level to support this transition. Furthermore, by addressing both hypertension and diabetes, the ANDES strategy supports integrated care approaches advocated by the WHO HEARTS technical package, ultimately enhancing health outcomes and reducing morbidity and mortality in the region. Trial registration ClinicalTrials.gov, ID: NCT05524987 , Addressing Hypertension and Diabetes through Community-Engaged Systems in Puno, Peru (ANDES study), prospectively registered on September 1, 2021.https://doi.org/10.1186/s13063-024-08586-9HypertensionType 2 diabetesCommunity health workersTask-shiftingWHO HEARTSImplementation |
| spellingShingle | Lindsay J. Underhill Kendra N. Williams Lucy Cordova-Ascona Karina Campos Lisa de las Fuentes Mark D. Huffman Joel Gittelsohn Kenneth B. Schechtman Zoila Vela-Clavo Carla Tarazona-Meza Laura K. Beres Parker K. Acevedo Abigail Barker Nishadi Rajapakse Makeda Williams Veronica Tonwe Aaloke Mody Raquel Hurtado Juan Carlos Mendoza Gonzalo Cuentas Elvin H. Geng William Checkley Victor G. Dávila-Román Stella M. Hartinger-Peña Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trial Trials Hypertension Type 2 diabetes Community health workers Task-shifting WHO HEARTS Implementation |
| title | Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trial |
| title_full | Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trial |
| title_fullStr | Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trial |
| title_full_unstemmed | Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trial |
| title_short | Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trial |
| title_sort | addressing hypertension and diabetes through community engaged systems andes in puno peru rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trial |
| topic | Hypertension Type 2 diabetes Community health workers Task-shifting WHO HEARTS Implementation |
| url | https://doi.org/10.1186/s13063-024-08586-9 |
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