scholarly journals Personalized Hypertension Management Based on Serial Assessment and Telemedicine: a Cluster Randomize Controlled Trial Protocol in Anhui, China

2020 ◽  
Author(s):  
Siyi Xiao ◽  
Xingrong Shen ◽  
Rong Liu ◽  
Guixian Tong ◽  
Tongzhu Liu ◽  
...  

Abstract Background: Despite tremendous investment worldwide, hypertension treatment and control rates remain low, suggesting that contemporary population-based hypertension management may have reached its efficacy ceiling. The complexity and long-term dynamics of influencing factors make personalized management inevitable and challenging. This protocol describes Personalized Hypertension Management in Anhui, China (PHMA), a project that uses a package of innovative approaches in tailoring interventions to individual patient’s dynamic complications and contexts.Methods/design: PHMA strives to reduce hypertension harms by eight proven “objective behaviors” (e.g., self-monitoring and reporting, healthy diet, physical exercise/activities). These objective behaviors are promoted through five intervention measures: support for self- monitoring, supervised machine communications, daily education or reminder messages, weekly blood pressure notification, and quarterly signed feedback. PHMA uses ten categories and over 300 variables in selecting and refining intervention procedures and content for individual patients. Efficacy of the intervention package is evaluated using a cluster randomized controlled trial design involving a total of 60 site communities and 3352 hypertension patients. Primary measure for the evaluation is systolic and diastolic blood pressure; while secondary evaluation measures include quality of life (EQ5D-5L), occurrence of hypertension-related complications (such as cerebral hemorrhage, coronary heart disease, myocardial or cerebral infarction), healthcare utilization and scores of objective behaviors.Discussion: PHMA uses novel, low cost and sustainable approaches to tailor interventions to the dynamic conditions and contexts of individual patients. Unlike contemporary approaches to hypertension management which are mainly population based, each participant patient in PHMA applies a unique intervention package and all messages, feedbacks and other materials sent out to individual patients are different from each other. PHMA is the first project that adopts so comprehensive tailoring and if proved effective, it should have important implications for future research, practice and policy-making.Trial registration: Registered July 17, 2020. ISRCTN10999269.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xingrong Shen ◽  
Siyi Xiao ◽  
Rong Liu ◽  
Guixian Tong ◽  
Tongzhu Liu ◽  
...  

Abstract Background Despite tremendous investment worldwide, hypertension treatment and control rates remain low. The complexity and long-term dynamics of influencing factors make personalized management inevitable and challenging. This protocol describes Personalized Hypertension Management in Anhui, China (PHMA), a project that uses a package of innovative approaches in tailoring interventions to individual patient’s dynamic complications and contexts. Methods/design PHMA strives to reduce hypertension harms by eight “objective behaviors” (e.g., self-monitoring and reporting, healthy diet, physical exercise/activities). These objective behaviors are promoted through five intervention measures: support for self- monitoring, supervised machine communications, daily education or reminder messages, weekly blood pressure notification, and quarterly signed feedback. PHMA uses ten categories and over 300 variables in selecting and refining intervention procedures and content for individual patients. Efficacy of the intervention package is evaluated using a cluster randomized controlled trial design involving a total of 60 site communities and 3352 hypertension patients. Primary measure for the evaluation is systolic and diastolic blood pressure; while secondary evaluation measures include quality of life (EQ5D-5L), occurrence of hypertension-related complications (such as cerebral hemorrhage, coronary heart disease, myocardial or cerebral infarction), healthcare utilization and scores of objective behaviors. Discussion PHMA uses novel, low cost and sustainable approaches to tailor interventions to the dynamic conditions and contexts of individual patients. Unlike contemporary approaches to hypertension management which are mainly population based, each participant patient in PHMA applies a unique intervention package and all messages, feedbacks and other materials sent out to individual patients are different from each other. PHMA is the first project that adopts comprehensive tailoring and if proved effective, it should have important implications for future research, practice and policy-making. Trial registration ISRCTN10999269. July 17, 2020; https://doi.org/10.1186/ISRCTN10999269.


2020 ◽  
Author(s):  
Siyi Xiao ◽  
Xingrong Shen ◽  
Rong Liu ◽  
Guixian Tong ◽  
Tongzhu Liu ◽  
...  

Abstract Background: Despite tremendous investment worldwide, hypertension treatment and control rates remain low, suggesting that contemporary population-based hypertension management may have reached its efficacy ceiling. The complexity and long-term dynamics of influencing factors make personalized management inevitable and challenging. This protocol describes Personalized Hypertension Management in Anhui, China (PHMA), a project that uses a package of innovative approaches in tailoring interventions to individual patient’s dynamic complications and contexts.Methods/design: PHMA strives to reduce hypertension harms by eight proven “objective behaviors” (e.g., self-monitoring and reporting, healthy diet, physical exercise/activities). These objective behaviors are promoted through five intervention measures: support for self- monitoring, supervised machine communications, daily education or reminder messages, weekly blood pressure notification, and quarterly signed feedback. PHMA uses ten categories and over 300 variables in selecting and refining intervention procedures and content for individual patients. Efficacy of the intervention package is evaluated using a cluster randomized controlled trial design involving a total of 60 site communities and 3352 hypertension patients. Primary measure for the evaluation is systolic and diastolic blood pressure; while secondary evaluation measures include quality of life (EQ5D-5L), occurrence of hypertension-related complications (such as cerebral hemorrhage, coronary heart disease, myocardial or cerebral infarction), healthcare utilization and scores of objective behaviors.Discussion: PHMA uses novel, low cost and sustainable approaches to tailor interventions to the dynamic conditions and contexts of individual patients. Unlike contemporary approaches to hypertension management which are mainly population based, each participant patient in PHMA applies a unique intervention package and all messages, feedbacks and other materials sent out to individual patients are different from each other. PHMA is the first project that adopts so comprehensive tailoring and if proved effective, it should have important implications for future research, practice and policy-making.Trial registration: ISRCTN10999269. July 17, 2020; https://doi.org/10.1186/ISRCTN10999269


Hypertension ◽  
2021 ◽  
Vol 78 (Suppl_1) ◽  
Author(s):  
Jarod Parrish ◽  
Ciantel A Blyler ◽  
Henry E Okafor ◽  
L. Cindy Chang ◽  
Devika Nair ◽  
...  

Background: The Los Angeles Barbershop Blood Pressure Study (LABBPS) demonstrated that collaboration between barbers and pharmacists delivering hypertension management could significantly improve blood pressure as well as access to care. It is unknown if this model can be translated to other locations. This single-arm, proof-of-concept pilot study tested the development and implementation of a similar protocol in Nashville, TN (NCT04232124). Methods: Between 2019 and 2021, community stakeholders, clinicians, investigators, and the LABBPS team convened to adapt the study design and protocol. Established barbershops with barbers willing to be trained on study procedures were recruited as study sites. Non-Hispanic Black male clients, aged 35-79 years with systolic blood pressure (SBP) > 140 mmHg on two screening days were eligible for participation. Enrolled participants met with a pharmacist for lifestyle and medication management at least once monthly for a six-month period. Barbers measured blood pressure during haircuts for additional monitoring. Results: Eight barbershops in business for an average of 20 (± 5) years participated in the trial. Barbers from each shop (range: 1-4) were trained. A total of 419 clients completed screening visit 1, 82 were eligible and 52 (12%) completed visit 2. We enrolled 36, with 30 completing the initial clinical visit and 27 had complete data at 6-months. Participants were on average age 50 (± 10) years, had a body mass index 33 (± 6), 44% were currently smoking, 52% with high school or less education, and 56% reported current primary care. Baseline BP 157.7±17.1/ 95.1±13.9 mmHg improved to 125.7±11.9/75.6±9.5, a change of -32.1±21.6/ -19.5±14.1, respectively. At 6-months 85% of the group had a BP<140/90, 74% BP<135/85, and 67% BP<130/80. At baseline 15% of participants reported health as excellent/very good and this increased to 56% at 6-months (p=0.002). Adverse reactions reported were minimal. Conclusion: Implementation of the barber-pharmacist model of hypertension management and care delivery improved BP control among hypertensive Black men in Nashville. Lessons learned regarding adaptation overcoming unforeseen barriers will inform expansion into additional naïve locations for future research.


2020 ◽  
Vol 125 (3) ◽  
pp. 217-229 ◽  
Author(s):  
Karrie A. Shogren ◽  
Tyler A. Hicks ◽  
Kathryn M. Burke ◽  
Anthony Antosh ◽  
Terri LaPlante ◽  
...  

Abstract The purpose of this study was to examine self-determination outcome data in the year following a one-year cluster randomized controlled trial (C-RCT) comparing the impacts of a Self-Determined Learning Model of Instruction (SDLMI) only condition to a SDLMI + Whose Future Is It? (SDLMI + WF) condition. Using multilevel B-spline model analysis with Bayesian estimation, we examined ongoing patterns of growth after the trial ended and all students were exposed to SDLMI + WF. The findings suggest that the inclusion of an additional year of outcome data provided additional insight into the impact of more intensive intervention conditions over time. Specifically, after the initial year of implementation, the SDLMI + WF condition predicted greater annual gains than the SDLMI only condition, unlike findings in the first year which reflected the opposite pattern. This evidence suggests a nonlinear growth pattern over multiple years of intervention with more intensive interventions. Implications for future research and practice are discussed.


2019 ◽  
Author(s):  
Asaad Ahmed Nafees ◽  
Sara De Matteis ◽  
Muhammad Masood Kadir ◽  
Peter Burney ◽  
David Coggon ◽  
...  

Abstract Background In the Pakistani textile industry the prevalence of workplace respiratory illnesses, including byssinosis, is high. This study aims to determine the effectiveness of a multifaceted intervention package in reducing dust levels in cotton mills, decreasing the frequency of respiratory symptoms among cotton textile workers, and improving their lung function. Methods/design We will conduct a cluster-randomized controlled trial at 28 textile mills in Karachi. The intervention will comprise: training in occupational health for all workers and managers backed by regular refresher sessions; the formation of workplace committees to draw up, agree and promote a health and safety plan that includes wet mopping, safe disposal of cotton dust, and the use of simple face masks, as well as further publicity about the risks from cotton dust; and provision of adequate supplies of face masks to support the health and safety plan. Participating mills will be randomized to intervention and control arms following a baseline survey. The impact of the intervention will be determined through follow-up surveys conducted at 3, 12 and 18 months. Data collection in the surveys will include spirometry, questionnaire-based interviews and cotton dust measurements. Discussion If successful, the study may pave the way for simple, low-cost interventions that can help reduce cotton dust levels in textile mills, and improve the respiratory health of textile workers in developing countries such as Pakistan.


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