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Home Blood Pressure Self-monitoring plus Self-titration of Antihypertensive Medication for Poorly Controlled Hypertension in Primary Care: the ADAMPA Randomized Clinical Trial.

ABSTRACT: Patient empowerment through pharmacological self-management is a common strategy in some chronic diseases such as diabetes, but it is rarely used for controlling blood pressure. This study aimed to assess self-monitoring plus self-titration of antihypertensive medication versus usual care for reducing systolic blood pressure (SBP) at 12 months in poorly controlled hypertensive patients. The ADAMPA study was a pragmatic, controlled, randomized, non-masked clinical trial with two parallel arms in Valencia, Spain. Hypertensive patients older than 40 years, with SBP over 145 mmHg and/or diastolic blood pressure (DBP) over 90 mmHg, were recruited from July 2017 to June 2018. Participants were randomized 1:1 to usual care versus an individualized, pre-arranged plan based on self-monitoring plus self-titration. The primary outcome was the adjusted mean difference (AMD) in SBP between groups at 12 months. Primary outcome data were available for 312 patients (intervention n=156, control n=156) of the 366 who were initially recruited. The AMD in SBP at 12 months (main analysis) was -2.9 mmHg (95% CI, -5.9 to 0.1, p=0.061), while the AMD in DBP was -1.9 mmHg (95% CI, -3.7 to 0.0, p=0.052). The results of the subgroup analysis were consistent with these for the main outcome measures. More patients in the intervention group achieved good blood pressure control (<140/90 mmHg) at 12 months than in the control group (55.8% vs 42.3%, difference 13.5%, 95% CI, 2.5 to 24.5%, p=0.017). At 12 months, no differences were observed in behavior, quality of life, use of health services, or adverse events. Self-monitoring plus self-titration of antihypertensive medication based on an individualized pre-arranged plan used in primary care may be a promising strategy for reducing blood pressure at 12 months compared to usual care, without increasing healthcare utilization or adverse events. EudraCT, number 2016-003986-25 (registered 17 March 2017) and clinicaltrials.gov , NCT03242785.

SUBMITTER: Martinez-Ibanez P

PROVIDER: S-EPMC9849508 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Home Blood Pressure Self-monitoring plus Self-titration of Antihypertensive Medication for Poorly Controlled Hypertension in Primary Care: the ADAMPA Randomized Clinical Trial.

Martínez-Ibáñez Patricia P Marco-Moreno Irene I Peiró Salvador S Martínez-Ibáñez Lucia L Barreira-Franch Ignacio I Bellot-Pujalte Laura L Avelino-Hidalgo Eugenia E Escrig-Veses Marina M Bóveda-García María M Calleja-Del-Ser Mercedes M Ferrero-Gregori Andreu A Iftimi Adina A AA Hurtado Isabel I García-Sempere Aníbal A Rodríguez-Bernal Clara L CL Giménez-Loreiro Margarita M Sanfélix-Gimeno Gabriel G Sanfélix-Genovés José J

Journal of general internal medicine 20221011 1

<h4>Background</h4>Patient empowerment through pharmacological self-management is a common strategy in some chronic diseases such as diabetes, but it is rarely used for controlling blood pressure.<h4>Objective</h4>This study aimed to assess self-monitoring plus self-titration of antihypertensive medication versus usual care for reducing systolic blood pressure (SBP) at 12 months in poorly controlled hypertensive patients.<h4>Design</h4>The ADAMPA study was a pragmatic, controlled, randomized, no ...[more]

PMID: 36219303

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Project description:BackgroundStudies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care.MethodsThis study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366.Findings1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, -3·5 mm Hg [95% CI -5·8 to -1·2]; telemonitoring, -4·7 mm Hg [-7·0 to -2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference -1·2 mm Hg [95% CI -3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups.InterpretationSelf-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care.FundingNational Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK.

Project description:BackgroundDespite 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 control.ObjectiveThe aim of our study will be to evaluate the effects of telemonitoring with antihypertensive treatment titration on blood pressure control in Tunisian patients with hypertension.MethodsOur trial 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 enrollment if they are aged over 35 years, are newly diagnosed with hypertension, or are known to be poorly controlled on antihypertensive therapy. Participants will be randomly assigned in a 1:1 ratio to the telemonitoring arm or usual care arm. The telemonitoring arm will involve a weekly telephone call for the collection of the home blood pressure measurements, therapeutic education, and treatment compliance assessment as well as a monthly call for treatment titration and a side effect check. Randomization will be done via the use of an interactive web responsive system, and patients will be stratified by investigation center. Neither participants nor investigators will be masked to the group assignments. The primary outcome will be the change in mean 24-hour systolic blood pressure from baseline to the 6-month follow-up in the 2 groups. All randomized patients who attend the follow-up visit at 6 months and have no missing data for the primary outcome will be included in the analysis.ResultsRecruitment 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 by the end of 2021 and plan to disseminate the results subsequently.ConclusionsThe HOROSCOPE (Home Telemonitoring of Arterial Hypertension With Antihypertensive Treatment Titration: Randomized Controlled Prospective Trial) study will provide important new evidence that could shed some light on the feasibility and impact of telemonitoring and self-monitoring in a Tunisian population of patients with hypertension who consult primary care physicians.Trial registrationClinicalTrials.gov NCT04607239; https://clinicaltrials.gov/ct2/show/NCT04607239.International registered report identifier (irrid)DERR1-10.2196/26184.

Dataset Information

Home Blood Pressure Self-monitoring plus Self-titration of Antihypertensive Medication for Poorly Controlled Hypertension in Primary Care: the ADAMPA Randomized Clinical Trial.

Publications

Home Blood Pressure Self-monitoring plus Self-titration of Antihypertensive Medication for Poorly Controlled Hypertension in Primary Care: the ADAMPA Randomized Clinical Trial.

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