Home Telemonitoring of Arterial Hypertension with Antihypertensive Treatment Titration: Protocol of a Randomized Controlled Prospective Trial (HOROSCOPE Study) (Preprint)

2020 ◽  
Author(s):  
SONIA Ben Hafaiedh ◽  
Yosra Ben Daya ◽  
Amina Hadjer Radoui ◽  
Mohamed Bouchoucha ◽  
Rabie Razgallah ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Primary Care Physicians ◽  
Primary Outcome ◽  
Prospective Trial ◽  
Treatment Compliance ◽  
Therapeutic Education ◽  
Randomized Controlled ◽  
Sahel Region

BACKGROUND Despite the availability of effective treatment, the control of hypertension remains insufficient. Telemonitoring in the management of hypertension would be an effective way to improve blood pressure (BP) control. OBJECTIVE The aim of this study is to evaluate the effects of telemonitoring with anti-hypertensive treatment titration on blood pressure control in Tunisian hypertensive patients. METHODS It will be a prospective, rater blinded, randomized, controlled trial carried out with primary care physicians in the Sahel region of Tunisia. Patients will be eligible for enrolment if they are over 35 years of age, newly diagnosed with hypertension, or known to be poorly controlled on antihypertensive therapy. Participants will be randomly assigned in a 1:1 ratio to the telemonitoring or usual care arm. The telemonitoring arm involves of a weekly telephone call for collection of the home BP measurements, therapeutic education, treatment compliance assessment, as well as having a monthly call for treatment titration and side effects check. Randomization will be done by use of interactive web responsive system (IWRS) and will be stratified by investigation centers. Neither participants nor investigators will be masked to groups’ assignment. The primary outcome is the change from baseline in the 2 groups of mean 24-hour systolic blood pressure (SBP) at 6 months of follow-up. All randomized patients who will attend the follow-up visit at 6 months and have no missing data for the primary outcome will be included in the analysis. RESULTS Recruitment to the trial started in July 2020. The study was initiated with 17 primary care physicians. We expect the inclusion period to last for approximately 6 months. We expect to complete data collection at the end of 2021 and plan the dissemination of the results subsequently. CONCLUSIONS The HOROSCOPE trial will provide important new evidence that could shed some light on the feasibility and impact of telemonitoring along with self-monitoring in a Tunisian hypertensive population consulting in primary care. CLINICALTRIAL Trial Registration: ClinicalTrials.gov identifier: NCT04607239;

scholarly journals A Mobile Health Salt Reduction Intervention for People With Hypertension: Results of a Feasibility Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Sarah Payne Riches ◽  
Carmen Piernas ◽  
Paul Aveyard ◽  
James P Sheppard ◽  
Mike Rayner ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Salt Intake ◽  
Controlled Trial ◽  
Salt Content ◽  
Salt Reduction ◽  
Randomized Controlled ◽  
Secondary Outcomes

BACKGROUND A high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs. OBJECTIVE The aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention’s effectiveness. METHODS This feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated. RESULTS A total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors. CONCLUSIONS The intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962

scholarly journals A Mobile Health Salt Reduction Intervention for People With Hypertension: Results of a Feasibility Randomized Controlled Trial

10.2196/26233 ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. e26233
Author(s):  
Sarah Payne Riches ◽  
Carmen Piernas ◽  
Paul Aveyard ◽  
James P Sheppard ◽  
Mike Rayner ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Salt Intake ◽  
Controlled Trial ◽  
Salt Content ◽  
Salt Reduction ◽  
Randomized Controlled ◽  
Secondary Outcomes

Background A high-salt diet is a risk factor for hypertension and cardiovascular disease; therefore, reducing dietary salt intake is a key part of prevention strategies. There are few effective salt reduction interventions suitable for delivery in the primary care setting, where the majority of the management and diagnosis of hypertension occurs. Objective The aim of this study is to assess the feasibility of a complex behavioral intervention to lower salt intake in people with elevated blood pressure and test the trial procedures for a randomized controlled trial to investigate the intervention’s effectiveness. Methods This feasibility study was an unblinded, randomized controlled trial of a mobile health intervention for salt reduction versus an advice leaflet (control). The intervention was developed using the Behavior Change Wheel and comprised individualized, brief advice from a health care professional with the use of the SaltSwap app. Participants with an elevated blood pressure recorded in the clinic were recruited through primary care practices in the United Kingdom. Primary outcomes assessed the feasibility of progression to a larger trial, including follow-up attendance, fidelity of intervention delivery, and app use. Secondary outcomes were objectively assessed using changes in salt intake (measured via 24-hour urine collection), salt content of purchased foods, and blood pressure. Qualitative outcomes were assessed using the think-aloud method, and the process outcomes were evaluated. Results A total of 47 participants were randomized. All progression criteria were met: follow-up attendance (45/47, 96%), intervention fidelity (25/31, 81%), and app use (27/31, 87%). There was no evidence that the intervention significantly reduced the salt content of purchased foods, salt intake, or blood pressure; however, this feasibility study was not powered to detect changes in secondary outcomes. Process and qualitative outcomes demonstrated that the trial design was feasible and the intervention was acceptable to both individuals and practitioners and positively influenced salt intake behaviors. Conclusions The intervention was acceptable and feasible to deliver within primary care; the trial procedures were practicable, and there was sufficient signal of potential efficacy to change salt intake. With some improvements to the intervention app, a larger trial to assess intervention effectiveness for reducing salt intake and blood pressure is warranted. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 20910962; https://www.isrctn.com/ISRCTN20910962

scholarly journals Understanding the clinical reasoning processes involved in the management of multimorbidity in an ambulatory setting: study protocol of a stimulated recall research

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
M.-C. Audétat ◽  
S. Cairo Notari ◽  
J. Sader ◽  
C. Ritz ◽  
T. Fassier ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Reasoning ◽  
Primary Care Physicians ◽  
Video Sequence ◽  
Structured Interview ◽  
Ambulatory Setting ◽  
Structured Interviews ◽  
Stimulated Recall ◽  
Study Results

Abstract Background Primary care physicians are at the very heart of managing patients suffering from multimorbidity. However, several studies have highlighted that some physicians feel ill-equipped to manage these kinds of complex clinical situations. Few studies are available on the clinical reasoning processes at play during the long-term management and follow-up of patients suffering from multimorbidity. This study aims to contribute to a better understanding on how the clinical reasoning of primary care physicians is affected during follow-up consultations with these patients. Methods A qualitative research project based on semi-structured interviews with primary care physicians in an ambulatory setting will be carried out, using the video stimulated recall interview method. Participants will be filmed in their work environment during a standard consultation with a patient suffering from multimorbidity using a “button camera” (small camera) which will be pinned to their white coat. The recording will be used in a following semi-structured interview with physicians and the research team to instigate a stimulated recall. Stimulated recall is a research method that allows the investigation of cognitive processes by inviting participants to recall their concurrent thinking during an event when prompted by a video sequence recall. During this interview, participants will be prompted by different video sequence and asked to discuss them; the aim will be to encourage them to make their clinical reasoning processes explicit. Fifteen to twenty interviews are planned to reach data saturation. The interviews will be transcribed verbatim and data will be analysed according to a standard content analysis, using deductive and inductive approaches. Conclusion Study results will contribute to the scientific community’s overall understanding of clinical reasoning. This will subsequently allow future generation of primary care physicians to have access to more adequate trainings to manage patients suffering from multimorbidity in their practice. As a result, this will improve the quality of the patient’s care and treatments.

scholarly journals Conservative oxygen therapy for critically ill patients: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Xiao-Li Chen ◽  
Bei-Lei Zhang ◽  
Chang Meng ◽  
Hui-Bin Huang ◽  
Bin Du
Keyword(s):  
Sensitivity Analysis ◽  
Randomized Controlled Trials ◽  
Critically Ill Patients ◽  
Oxygen Therapy ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Icu Patients ◽  
Randomized Controlled

Abstract Objective Conservative oxygen strategy is recommended in acute illness while its benefit in ICU patients remains controversial. Therefore, we sought to conduct a systematic review and meta-analysis to examine such oxygen strategies’ effect and safety in ICU patients. Methods We searched PubMed, Embase, and the Cochrane database from inception to Feb 15, 2021. Randomized controlled trials (RCTs) that compared a conservative oxygen strategy to a conventional strategy in critically ill patients were included. Results were expressed as mean difference (MD) and risk ratio (RR) with a 95% confidence interval (CI). The primary outcome was the longest follow-up mortality. Heterogeneity, sensitivity analysis, and publication bias were also investigated to test the robustness of the primary outcome. Results We included seven trials with a total of 5265 patients. In general, the conventional group had significantly higher SpO2 or PaO2 than that in the conservative group. No statistically significant differences were found in the longest follow-up mortality (RR, 1.03; 95% CI, 0.97–1.10; I2=18%; P=0.34) between the two oxygen strategies when pooling studies enrolling subjects with various degrees of hypoxemia. Further sensitivity analysis showed that ICU patients with mild-to-moderate hypoxemia (PaO2/FiO2 >100 mmHg) had significantly lower mortality (RR, 1.24; 95% CI, 1.05–1.46; I2=0%; P=0.01) when receiving conservative oxygen therapy. These findings were also confirmed in other study periods. Additional, secondary outcomes of the duration of mechanical ventilation, the length of stay in the ICU and hospital, change in sequential organ failure assessment score, and adverse events were comparable between the two strategies. Conclusions Our findings indicate that conservative oxygen therapy strategy did not improve the prognosis of the overall ICU patients. The subgroup of ICU patients with mild to moderate hypoxemia might obtain prognosis benefit from such a strategy without affecting other critical clinical results.

scholarly journals Examining the effectiveness of telemonitoring with routinely acquired blood pressure data in primary care: challenges in the statistical analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Richard A. Parker ◽  
Paul Padfield ◽  
Janet Hanley ◽  
Hilary Pinnock ◽  
John Kennedy ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Statistical Analysis ◽  
Propensity Score ◽  
Random Coefficient ◽  
White Coat ◽  
White Coat Effect ◽  
Regression Adjustment ◽  
The Impact

Abstract Background Scale-up BP was a quasi-experimental implementation study, following a successful randomised controlled trial of the roll-out of telemonitoring in primary care across Lothian, Scotland. Our primary objective was to assess the effect of telemonitoring on blood pressure (BP) control using routinely collected data. Telemonitored systolic and diastolic BP were compared with surgery BP measurements from patients not using telemonitoring (comparator patients). The statistical analysis and interpretation of findings was challenging due to the broad range of biases potentially influencing the results, including differences in the frequency of readings, ‘white coat effect’, end digit preference, and missing data. Methods Four different statistical methods were employed in order to minimise the impact of these biases on the comparison between telemonitoring and comparator groups. These methods were “standardisation with stratification”, “standardisation with matching”, “regression adjustment for propensity score” and “random coefficient modelling”. The first three methods standardised the groups so that all participants provided exactly two measurements at baseline and 6–12 months follow-up prior to analysis. The fourth analysis used linear mixed modelling based on all available data. Results The standardisation with stratification analysis showed a significantly lower systolic BP in telemonitoring patients at 6–12 months follow-up (-4.06, 95% CI -6.30 to -1.82, p < 0.001) for patients with systolic BP below 135 at baseline. For the standardisation with matching and regression adjustment for propensity score analyses, systolic BP was significantly lower overall (− 5.96, 95% CI -8.36 to − 3.55 , p < 0.001) and (− 3.73, 95% CI− 5.34 to − 2.13, p < 0.001) respectively, even after assuming that − 5 of the difference was due to ‘white coat effect’. For the random coefficient modelling, the improvement in systolic BP was estimated to be -3.37 (95% CI -5.41 to -1.33 , p < 0.001) after 1 year. Conclusions The four analyses provide additional evidence for the effectiveness of telemonitoring in controlling BP in routine primary care. The random coefficient analysis is particularly recommended due to its ability to utilise all available data. However, adjusting for the complex array of biases was difficult. Researchers should appreciate the potential for bias in implementation studies and seek to acquire a detailed understanding of the study context in order to design appropriate analytical approaches.

Abstract P136: Healthier Personal Habits Of Primary Care Physicians Increase The Likelihood Of Their Recommending Lifestyle Modifications For Their Hypertensive Patients That Are Consistent With The National Guidelines

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Olivia Y Hung ◽  
Nora L Keenan ◽  
Jing Fang
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
High Blood Pressure ◽  
Primary Care Physicians ◽  
Lifestyle Modification ◽  
Lifestyle Interventions ◽  
Lifestyle Modifications ◽  
Hypertensive Patients ◽  
Attitudes And Behaviors ◽  
And Behaviors

Introduction: The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) recommended lifestyle interventions, either with or without pharmacologic treatment, for all patients with high blood pressure. The objective of this study is to determine the association of physicians’ personal habits with their attitudes and behaviors regarding JNC VII lifestyle modification guidelines. Hypothesis: Primary care physicians who have healthier habits, as defined by eating more cups of fruits and/or vegetables, exercising more frequently, and/or not smoking, would be more likely to recommend lifestyle interventions consistent with JNC VII than their counterparts who have less healthy habits. Methods: One thousand primary care physicians completed DocStyles 2010, a voluntary web-based survey designed to provide insight into physician attitudes and behaviors regarding various health issues. Results: The respondents’ average age was 45.3 years and 68.5% (685 of 1000) were male. In regards to physician behavior, 4.0% (40 of 1000) smoked at least once a week, 38.6% (386 of 1000) ate ≥5 cups of fruits and/or vegetables ≥5 days/week, and 27.4% (274 of 1000) exercised ≥5 days/week. When asked about specific types of advice offered to their hypertensive patients, physicians reported recommending that their patients eat a healthy diet (922 of 1000), or cut down on salt (961 of 1000), or attain or maintain a healthy weight (948 of 1000), or limit the use of alcohol (754 of 1000), or be physically active (944 of 1000). Collectively, 66.5% (665 of 1000) made all 5 lifestyle modification recommendations. Physicians who were between 40 - 49 years old were 1.6 times as likely of making all 5 lifestyle recommendations compared with those who were under 40 years. Additionally, those who exercised at least once per week or did not actively smoke were approximately twice as likely to recommend these interventions. Conclusions: The probability of recommending all five lifestyle modifications increased with both the physician exercising at least once per week and not having smoked.

scholarly journals The Differences in the Prevalence of Cardiovascular Disease, Its Risk Factors, and Achievement of Therapeutic Goals among Urban and Rural Primary Care Patients in Poland: Results from the LIPIDOGRAM 2015 Study

2021 ◽  
Vol 10 (23) ◽  
pp. 5656
Author(s):  
Krzysztof Studziński ◽  
Tomasz Tomasik ◽  
Adam Windak ◽  
Maciej Banach ◽  
Ewa Wójtowicz ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Primary Care ◽  
Rural Areas ◽  
Urban Areas ◽  
Primary Care Physicians ◽  
Primary Care Patient ◽  
Care Patient ◽  
Cross Sectional ◽  
Therapeutic Goals ◽  
Rural Primary Care

A nationwide cross-sectional study, LIPIDOGRAM2015, was carried out in Poland in the years 2015 and 2016. A total of 438 primary care physicians enrolled 13,724 adult patients that sought medical care in primary health care practices. The prevalence of hypertension, diabetes mellitus, dyslipidaemia, and CVD were similar in urban and rural areas (49.5 vs. 49.4%; 13.7 vs. 13.1%; 84.2 vs. 85.2%; 14.4 vs. 14.2%, respectively). The prevalence of obesity (32.3 vs. 37.5%, p < 0.01) and excessive waist circumference (77.5 vs. 80.7%, p < 0.01), as well as abdominal obesity (p = 43.2 vs. 46.4%, p < 0.01), were higher in rural areas in both genders. Mean levels of LDL-C (128 vs. 130 mg/dL, p = 0.04) and non-HDL-C (147 vs. 148 mg/dL, p = 0.03) were slightly higher in rural populations. Altogether, 14.3% of patients with CVD from urban areas and 11.3% from rural areas reached LDL <70 mg/dL (p = 0.04). There were no important differences in the prevalence of hypertension, diabetes, dyslipidaemia, and CVD, or in mean levels of blood pressure, cholesterol fractions, glucose, and HbA1c between Polish urban and rural primary care patient populations. A high proportion of patients in cities and an even-higher proportion in rural areas did not reach the recommended targets for blood pressure, LDL-C, and HbA1c, indicating the need for novel CVD-prevention programs.

scholarly journals Optimizing childhood oncology care transition from pediatric to adult settings: A survey of primary care physicians’ and residents’ perspectives

2020 ◽  
Vol 43 (2) ◽  
pp. E14-23
Author(s):  
Sophie Marcoux, MD, PhD Marcoux ◽  
Caroline Laverdière
Keyword(s):  
Primary Care ◽  
Cancer Survivors ◽  
Childhood Cancer ◽  
Primary Care Physicians ◽  
Adult Survivors ◽  
Likert Scale ◽  
Care Transition ◽  
Term Care

Purpose: The majority of childhood cancer survivors suffer from late adverse effects after the completion of treatment. The prospect of most survivors reaching middle-age is a relatively new phenomenon, and the ways by which current and future primary care physicians (PCPs) will address this novel public health challenge are uncertain. Methods: A survey assessing knowledge level and information delivery preferences regarding long-term follow-up guidelines for adult patients having survived a childhood cancer was distributed by e-mail through the Quebec (Canada) national associations of PCPs and residents (n=238). Results: Participants reported an estimated average of 2.9 ± 1.9 cancer survivors in their yearly caseload, and only 35.3% recalled having provided services to at least one survivor in the last year. Most participants indicated ignoring validated follow-up guidelines for these patients (average score 1.66 on a Likert scale from “1—totally disagreeing” to “5—totally agreeing”). Scarce access to personalized follow-up guidelines and lack of clinical exposure to cancer survivors were identified as main obstacles in providing optimal care to these patients (respective averages of 1.66 and 1.84 on a Likert scale from “1— is a major obstacle” to “5—is not an obstacle at all”). Conclusion: The PCPs and residents rarely provide care for childhood cancer adult survivors. On an individual basis, there is a clear need for increased awareness, education and collaboration regarding long-term care of childhood cancer adult survivors during medical training. On a more global basis, structural, organizational and cultural changes are also needed to ensure adequate care transition.

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