Jashalynn German , Qing Yang , Daniel Hatch , Allison Lewinski , Hayden B. Bosworth , Brystana G. Kaufman , Ranee Chatterjee , Gina Pennington , Doreen Matters , Donghwan Lee , Diana Urlichich , Sarah Kokosa , Holly Canupp , Patrick Gregory , Cindy Leslie Roberson , Benjamin Smith , Sherry Huber , Katheryn Doukellis , Tammi Deal , Rose Burns , Ryan J. Shaw
{"title":"由护士提供的慢性病护理扩展技术（EXTEND）：随机试验的协议和基线数据。","authors":"Jashalynn German , Qing Yang , Daniel Hatch , Allison Lewinski , Hayden B. Bosworth , Brystana G. Kaufman , Ranee Chatterjee , Gina Pennington , Doreen Matters , Donghwan Lee , Diana Urlichich , Sarah Kokosa , Holly Canupp , Patrick Gregory , Cindy Leslie Roberson , Benjamin Smith , Sherry Huber , Katheryn Doukellis , Tammi Deal , Rose Burns , Ryan J. Shaw","doi":"10.1016/j.cct.2024.107673","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Approximately 10–15 % of individuals with type 2 diabetes have persistently poorly-controlled diabetes mellitus (PPDM) despite receiving available care, and frequently have comorbid hypertension. Mobile monitoring-enabled telehealth has the potential to improve outcomes in treatment-resistant chronic disease by supporting self-management and facilitating patient-clinician contact but must be designed in a manner amenable to real-world use.</p></div><div><h3>Methods</h3><p>Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) is an ongoing randomized trial comparing two 12-month interventions for comorbid PPDM and hypertension: 1) EXTEND, a mobile monitoring-enabled self-management intervention; and 2) EXTEND Plus, a comprehensive, nurse-delivered telehealth program incorporating mobile monitoring, self-management support, and pharmacist-supported medication management. Both arms leverage a novel platform that uses existing technological infrastructure to enable transmission of patient-generated health data into the electronic health record. The primary study outcome is difference in HbA1c change from baseline to 12 months. Secondary outcomes include blood pressure, weight, implementation barriers/facilitators, and costs.</p></div><div><h3>Results</h3><p>Enrollment concluded in June 2023 following randomization of 220 patients. Baseline characteristics are similar between arms; mean age is 54.5 years, and the cohort is predominantly female (63.6 %) and Black (68.2 %), with a baseline HbA1c of 9.81 %.</p></div><div><h3>Conclusion</h3><p>The EXTEND trial is evaluating two mobile monitoring-enabled telehealth approaches that seek to improve outcomes for patients with PPDM and hypertension. Critically, these approaches are designed around existing infrastructure, so may be amenable to implementation and scaling. This study will promote real-world use of telehealth to maximize benefits for those with high-risk chronic disease.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"146 ","pages":"Article 107673"},"PeriodicalIF":2.0000,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND): Protocol and Baseline Data for a Randomized Trial\",\"authors\":\"Jashalynn German , Qing Yang , Daniel Hatch , Allison Lewinski , Hayden B. Bosworth , Brystana G. Kaufman , Ranee Chatterjee , Gina Pennington , Doreen Matters , Donghwan Lee , Diana Urlichich , Sarah Kokosa , Holly Canupp , Patrick Gregory , Cindy Leslie Roberson , Benjamin Smith , Sherry Huber , Katheryn Doukellis , Tammi Deal , Rose Burns , Ryan J. Shaw\",\"doi\":\"10.1016/j.cct.2024.107673\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Approximately 10–15 % of individuals with type 2 diabetes have persistently poorly-controlled diabetes mellitus (PPDM) despite receiving available care, and frequently have comorbid hypertension. Mobile monitoring-enabled telehealth has the potential to improve outcomes in treatment-resistant chronic disease by supporting self-management and facilitating patient-clinician contact but must be designed in a manner amenable to real-world use.</p></div><div><h3>Methods</h3><p>Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) is an ongoing randomized trial comparing two 12-month interventions for comorbid PPDM and hypertension: 1) EXTEND, a mobile monitoring-enabled self-management intervention; and 2) EXTEND Plus, a comprehensive, nurse-delivered telehealth program incorporating mobile monitoring, self-management support, and pharmacist-supported medication management. Both arms leverage a novel platform that uses existing technological infrastructure to enable transmission of patient-generated health data into the electronic health record. The primary study outcome is difference in HbA1c change from baseline to 12 months. Secondary outcomes include blood pressure, weight, implementation barriers/facilitators, and costs.</p></div><div><h3>Results</h3><p>Enrollment concluded in June 2023 following randomization of 220 patients. Baseline characteristics are similar between arms; mean age is 54.5 years, and the cohort is predominantly female (63.6 %) and Black (68.2 %), with a baseline HbA1c of 9.81 %.</p></div><div><h3>Conclusion</h3><p>The EXTEND trial is evaluating two mobile monitoring-enabled telehealth approaches that seek to improve outcomes for patients with PPDM and hypertension. Critically, these approaches are designed around existing infrastructure, so may be amenable to implementation and scaling. This study will promote real-world use of telehealth to maximize benefits for those with high-risk chronic disease.</p></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\"146 \",\"pages\":\"Article 107673\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-08-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714424002568\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424002568","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND): Protocol and Baseline Data for a Randomized Trial
Background
Approximately 10–15 % of individuals with type 2 diabetes have persistently poorly-controlled diabetes mellitus (PPDM) despite receiving available care, and frequently have comorbid hypertension. Mobile monitoring-enabled telehealth has the potential to improve outcomes in treatment-resistant chronic disease by supporting self-management and facilitating patient-clinician contact but must be designed in a manner amenable to real-world use.
Methods
Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) is an ongoing randomized trial comparing two 12-month interventions for comorbid PPDM and hypertension: 1) EXTEND, a mobile monitoring-enabled self-management intervention; and 2) EXTEND Plus, a comprehensive, nurse-delivered telehealth program incorporating mobile monitoring, self-management support, and pharmacist-supported medication management. Both arms leverage a novel platform that uses existing technological infrastructure to enable transmission of patient-generated health data into the electronic health record. The primary study outcome is difference in HbA1c change from baseline to 12 months. Secondary outcomes include blood pressure, weight, implementation barriers/facilitators, and costs.
Results
Enrollment concluded in June 2023 following randomization of 220 patients. Baseline characteristics are similar between arms; mean age is 54.5 years, and the cohort is predominantly female (63.6 %) and Black (68.2 %), with a baseline HbA1c of 9.81 %.
Conclusion
The EXTEND trial is evaluating two mobile monitoring-enabled telehealth approaches that seek to improve outcomes for patients with PPDM and hypertension. Critically, these approaches are designed around existing infrastructure, so may be amenable to implementation and scaling. This study will promote real-world use of telehealth to maximize benefits for those with high-risk chronic disease.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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