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Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial

BACKGROUNDnControl of blood pressure is a key component of cardiovascular disease prevention, but is difficult to achieve and until recently has been the sole preserve of health professionals. This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care.nnnMETHODSnThis randomised controlled trial was undertaken in 24 general practices in the UK. Patients aged 35-85 years were eligible for enrolment if they had blood pressure more than 140/90 mm Hg despite antihypertensive treatment and were willing to self-manage their hypertension. Participants were randomly assigned in a 1:1 ratio to self-management, consisting of self-monitoring of blood pressure and self-titration of antihypertensive drugs, combined with telemonitoring of home blood pressure measurements or to usual care. Randomisation was done by use of a central web-based system and was stratified by general practice with minimisation for sex, baseline systolic blood pressure, and presence or absence of diabetes or chronic kidney disease. Neither participants nor investigators were masked to group assignment. The primary endpoint was change in mean systolic blood pressure between baseline and each follow-up point (6 months and 12 months). All randomised patients who attended follow-up visits at 6 months and 12 months and had complete data for the primary outcome were included in the analysis, without imputation for missing data. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN17585681.nnnFINDINGSn527 participants were randomly assigned to self-management (n=263) or control (n=264), of whom 480 (91%; self-management, n=234; control, n=246) were included in the primary analysis. Mean systolic blood pressure decreased by 12.9 mm Hg (95% CI 10.4-15.5) from baseline to 6 months in the self-management group and by 9.2 mm Hg (6.7-11.8) in the control group (difference between groups 3.7 mm Hg, 0.8-6.6; p=0.013). From baseline to 12 months, systolic blood pressure decreased by 17.6 mm Hg (14.9-20.3) in the self-management group and by 12.2 mm Hg (9.5-14.9) in the control group (difference between groups 5.4 mm Hg, 2.4-8.5; p=0.0004). Frequency of most side-effects did not differ between groups, apart from leg swelling (self-management, 74 patients [32%]; control, 55 patients [22%]; p=0.022).nnnINTERPRETATIONnSelf-management of hypertension in combination with telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care.nnnFUNDINGnDepartment of Health Policy Research Programme, National Coordinating Centre for Research Capacity Development, and Midlands Research Practices Consortium.

Patient self-monitoring of blood pressure and self-titration of medication in primary care: The TASMINH2 trial qualitative study of health professionals' experiences

BACKGROUNDnSelf-monitoring with self-titration of antihypertensives leads to reduced blood pressure. Patients are keen on self-monitoring but little is known about healthcare professional views.nnnAIMnTo explore health professionals views and experiences of patient self-management, particularly with respect to future implementation into routine care.nnnDESIGN AND SETTINGnQualitative study embedded within a randomised controlled trial of healthcare professionals participating in the TASMINH2 trial of patient self-monitoring with self-titration of antihypertensives from 24 West Midlands general practices.nnnMETHODnTaped and transcribed semi-structured interviews with 13 GPs, two practice nurses and one healthcare assistant. Constant comparative method of analysis.nnnRESULTSnPrimary care professionals were positive about self-monitoring, but procedures for ensuring patients measured blood pressure correctly were haphazard. GPs interpreted home readings variably, with many not making adjustment for lower home blood pressure. Interviewees were satisfied with patient training and arrangements for blood pressure monitoring and self-titration of medication during the trial, but less sure about future implementation into routine care. There was evidence of a need for training of both patients and professionals for successful integration of self-management.nnnCONCLUSIONnHealth professionals wanted more patient involvement in hypertension care but needed a framework to work within. Consideration of how to train patients to measure blood pressure and how home readings become part of their care is required before self-monitoring and self-titration can be implemented widely. As home monitoring becomes more widespread, the development of patient self-management, including self-titration of medication, should follow but this may take time to achieve.

Is screening for AF worthwhile? Stroke risk in a screened population from the SAFE study

INTRODUCTIONnAtrial fibrillation (AF) is an important independent risk factor for stroke and oral anticoagulation therapy provides a highly effective treatment to reduce this risk. Active screening strategies improve detection of AF in comparison with routine care; however, whether screen-detected patients have stroke risk profiles favouring anticoagulation is unclear. Using data derived from the screening for AF in the elderly (SAFE) study, the aim of this article was to determine if patients with AF detected via active screening have stroke risk profiles that warrant prophylactic anticoagulation.nnnMETHODSnSecondary analysis of data derived from 25 general practices within which cohorts of 200 patients were randomly allocated to opportunistic [pulse and electrocardiogram (ECG)] or systematic screening (postal invitation for ECG). Stroke risk assessment was undertaken using baseline data extracted from medical records and CHADS2 criteria. CHADS2 scores were compared between the screening groups.nnnRESULTSnOne hundred and forty-nine new cases of AF were detected, 75 via opportunistic screening and 74 via systematic screening. CHADS2 scores were ≥1 in 83% [95% confidence interval (CI) 72.6-89.6] of patients detected via opportunistic screening and 78% (95% CI 67.7-86.2) detected via systematic screening. There were no significant differences in stroke risk profiles of patients detected via opportunistic and systematic screenings.nnnCONCLUSIONnStroke risk profiles of patients detected via opportunistic and systematic screenings were similar. Data derived from the SAFE study suggest that active screening for AF in patients aged ≥65 years in primary care is a useful screening programme with 78-83% of patients identified eligible for anticoagulation treatment according to the CHADS2 criteria.

RANDOMISED CONTROLLED TRIAL OF TELEMONITORING AND SELF MANAGEMENT IN THE CONTROL OF HYPERTENSION: TELEMONITORING AND SELF MANAGEMENT IN HYPERTENSION (TASMINH2): ECONOMIC ANALYSIS

Introduction: Self management of hypertension including self monitoring and self titration of antihypertensives is a novel intervention aiming to improve blood pressure control. Very little evidence exists regarding the cost effectiveness of self monitoring of blood pressure in general and self management in particular. This study aimed to evaluate whether self management of hypertension was cost effective. Methods: The telemonitoring and self-management in hypertension trial (TASMINH2) was a primary care based randomised controlled trial comparing home monitoring of blood pressure with telemonitoring and self titration of anti hypertensive medication to usual care in people with poorly controlled hypertension. An embedded economic evaluation ran parallel to the main trial. It took a base case of costs from a UK Health Service perspective and analysed both cost per reduction in unit blood pressure and costs per QALY. Sensitivity analyses examined cost effectiveness from a societal point of view as well as evaluating the effect of missing values, different assumptions and bias due to high cost patients. Results: Self management of hypertension with telemonitoring was cost effective with an ICER for blood pressure reduction of £19/mm Hg (&U20AC;15/mm Hg) – implying that using self management with telemonitoring and titration of antihypertensive medication to reduce systolic BP by 1 mm Hg costs on average £19 (&U20AC;15). In terms of quality of life, compared to usual care, using self management with telemonitoring and titration of antihypertensive medication was associated with a gain of 0.0179 QALYs translating into a mean cost of just over £5,600 (&U20AC;4,462) per QALY gained. There was an 85% chance of this being cost effective given a willingness to pay of £20,000 (&U20AC;15,936) per QALY gained. This result was robust to sensitivity analysis around the assumptions made including from a societal perspective and removing high cost patients. Conclusions: Self monitoring with self titration of antihypertensives and telemonitoring of blood pressure measurements is cost effective as well as leading to reduced blood pressure. Figure 1. No caption available.

Patients' experiences of self-monitoring blood pressure and self-titration ofmedication: The TASMINH2 trial qualitative study

BACKGROUNDnSelf-management of hypertension, comprising self-monitoring of blood pressure with self-titration of medication, improves blood pressure control, but little is known regarding the views of patients undertaking it.nnnAIMnTo explore patients views of self-monitoring blood pressure and self-titration of antihypertensive medication.nnnDESIGN AND SETTINGnQualitative study embedded within the randomised controlled trial TASMINH2 (Telemonitoirng and Self Management in the Control of Hypertension) trial of patient self-management of hypertension from 24 general practices in the West Midlands.nnnMETHODnTaped and transcribed semi-structured interviews with 23 intervention patients were used. Six family members were also interviewed. Analysis was by a constant comparative method.nnnRESULTSnPatients were confident about self-monitoring and many felt their multiple home readings were more valid than single office readings taken by their GP. Although many patients self-titrated medication when required, others lacked the confidence to increase medication without reconsulting with their GP. Patients were more comfortable with titrating medication if their blood pressure readings were substantially above target, but were reluctant to implement such a change if readings were borderline. Many planned to continue self-monitoring after the study finished and report home readings to their GP, but few wished to continue with a self-management plan.nnnCONCLUSIONnParticipants valued the additional information and many felt confident in both self-monitoring blood pressure and self-titrating medication. The reluctance to change medication for borderline readings suggests behaviour similar to the clinical inertia seen for physicians in analogous circumstances. Additional support for those lacking in confidence to implement prearranged medication changes may allow more patients to undertake self-management.

Telemonitoring and self-management in the control of hypertension (TASMINH2): A randomised controlled trial

BACKGROUNDnControl of blood pressure is a key component of cardiovascular disease prevention, but is difficult to achieve and until recently has been the sole preserve of health professionals. This study assessed whether self-management by people with poorly controlled hypertension resulted in better blood pressure control compared with usual care.nnnMETHODSnThis randomised controlled trial was undertaken in 24 general practices in the UK. Patients aged 35-85 years were eligible for enrolment if they had blood pressure more than 140/90 mm Hg despite antihypertensive treatment and were willing to self-manage their hypertension. Participants were randomly assigned in a 1:1 ratio to self-management, consisting of self-monitoring of blood pressure and self-titration of antihypertensive drugs, combined with telemonitoring of home blood pressure measurements or to usual care. Randomisation was done by use of a central web-based system and was stratified by general practice with minimisation for sex, baseline systolic blood pressure, and presence or absence of diabetes or chronic kidney disease. Neither participants nor investigators were masked to group assignment. The primary endpoint was change in mean systolic blood pressure between baseline and each follow-up point (6 months and 12 months). All randomised patients who attended follow-up visits at 6 months and 12 months and had complete data for the primary outcome were included in the analysis, without imputation for missing data. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN17585681.nnnFINDINGSn527 participants were randomly assigned to self-management (n=263) or control (n=264), of whom 480 (91%; self-management, n=234; control, n=246) were included in the primary analysis. Mean systolic blood pressure decreased by 12.9 mm Hg (95% CI 10.4-15.5) from baseline to 6 months in the self-management group and by 9.2 mm Hg (6.7-11.8) in the control group (difference between groups 3.7 mm Hg, 0.8-6.6; p=0.013). From baseline to 12 months, systolic blood pressure decreased by 17.6 mm Hg (14.9-20.3) in the self-management group and by 12.2 mm Hg (9.5-14.9) in the control group (difference between groups 5.4 mm Hg, 2.4-8.5; p=0.0004). Frequency of most side-effects did not differ between groups, apart from leg swelling (self-management, 74 patients [32%]; control, 55 patients [22%]; p=0.022).nnnINTERPRETATIONnSelf-management of hypertension in combination with telemonitoring of blood pressure measurements represents an important new addition to control of hypertension in primary care.nnnFUNDINGnDepartment of Health Policy Research Programme, National Coordinating Centre for Research Capacity Development, and Midlands Research Practices Consortium.