Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4)

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McManus RJ, et al. "Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial". Lancet. 2018. 391(10124):949-959.
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Clinical Question

In patients with uncontrolled hypertension, does self-monitoring blood pressure at home, for antihypertensive titration in primary care, reduce blood pressure compared to in clinic blood pressure monitoring alone?

Bottom Line

Self-monitoring blood pressure to titrate antihypertensive therapy for patients with uncontrolled hypertension, results in lower systolic blood pressure within 12 months.

Major Points

Hypertension is the biggest cause for cardiovascular disease, leading to an increase in morbidity and mortality even though effective treatments are available and screenings prevalent. Self-monitoring blood pressure in combination with other interventions is very effective in obtaining a goal blood pressure.

This study was an unmasked, randomized, controlled trial conducted with 138 general practices throughout the UK, testing whether monitoring blood pressures at home would decrease systolic blood pressure over a period of 12 months. There was a significant difference in that the blood pressure readings were lower in patients assigned to self-monitor or telemonitor compared to the usual clinic blood pressure value over 12 months. There was no difference in diastolic blood pressure over the 12 month time frame among any groups.

Patients could benefit from utilizing self-monitoring blood pressure systems to reach their blood pressure goals or be able to adequately titrate antihypertensive medications to reach these goals. Further studies should be initiated to assess the cardiovascular outcomes and see if it reduces mortality and morbidity.

Guidelines

2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: “Out of office BP measurements are recommended to confirm diagnosis of hypertension and for titration of BP lowering medication, with telehealth counseling or clinical interventions” (Class 1, LOE A) -American College of Cardiology/American Heart Association (2017)

Design

  • Unmasked (unblinded), parallel, randomized, controlled trial
  • N=1182
    • Self-monitoring = 395
    • Telemonitoring = 393
    • Usual care = 394
  • Setting: 142 general practices in the UK that assessed eligible individuals; 138 practices enrolled
  • Enrollment: November 2014 to February 2016
  • Follow-up: 6 months and 12 months
  • Analysis: Intention-to-treat
  • Primary outcome: Systolic blood pressure at 12 months

Population

Inclusion Criteria

  • Age older than 35 years
  • Diagnosis of hypertension
  • Taking no more than three antihypertensive medications
  • Clinic blood pressure not below 140/90 mmHg
  • On stable antihypertensive medication for at least four weeks before randomization
  • No orthostatic hypertension, atrial fibrillation, dementia, chronic kidney disease of grade 4 or worse, or chronic kidney disease with proteinuria

Exclusion Criteria

  • Controlled blood pressure (<140/90 mmHg)
  • Orthostatic hypertension
  • No stable dose of antihypertensive medication
  • Atrial fibrillation
  • Unwilling to self-monitor
  • Unable to provide consent
  • Blood pressure managed outside of General Practitioner practice
  • Dementia
  • Pregnant or lactating
  • Chronic kidney disease Stage 4 or 5 or chronic kidney disease with proteinuria
  • Inability to obtain a blood pressure reading at the appointment

Baseline Characteristics

  • Mean age:
    • Self-monitoring group: 67 years
    • Telemonitoring group: 67 years
    • Usual care group: 66.8 years
  • Mean systolic blood pressure:
    • Self-monitoring group: 152.9 mmHg
    • Telemonitoring group: 153.2 mmHg
    • Usual care group: 153.1 mmHg
  • Mean diastolic blood pressure:
    • Self-monitoring group: 85.1 mmHg
    • Telemonitoring group: 85.5 mmHg
    • Usual care group: 86 mmHg
  • Sex:
    • Self-monitoring group: Male = 210, Female = 181
    • Telemonitoring group: Male = 208, Female = 181
    • Usual care group: Male = 210, Female = 183
  • Mean time since diagnosed with hypertension: 10.2 years
  • Majority ethnic representation: British white
  • Marital status:
    • Self-monitoring group: Married/cohabiting = 306, Single/widow/divorce = 85
    • Telemonitoring group: Married/cohabiting = 294, Single/widow/divorce = 95
    • Usual care group: Married/cohabiting = 305, Single/widow/divorce = 88
  • Occupation:
    • Self-monitoring group: retired (63%)
    • Telemonitoring group: retired (62%)
    • Usual care group: retired (65%)

Interventions

Patients were randomized into three groups: usual care, self-monitoring, or telemonitoring of blood pressure and underwent a medication review by his or her general practitioner


Usual care patients, or patients managed in the clinic, were managed with antihypertensive titration treatment based on clinic blood pressure measurements at the discretion of the health-care professional. The clinic measured systolic blood pressure readings after 12 months were the mean of the 2nd and 3rd reading of each individual


Patients in the at home blood pressure monitoring groups were taught to use validated automated electronic sphygmomanometers and asked to take blood pressure in their non-dominant arm, twice each morning and evening, for the first week of every month.

After each monitor week, the self-monitoring group patients were asked to mail in their recorded readings in a reply-paid envelope for their GP to review. Patients were provided with a guideline chart that contained simple colors. Very high or very low readings would require practice to check them. Four or more above target readings in two consecutive months would require a change in medication. Below target readings would simply require further monitoring the following month.

Patients in the telemonitoring group, were trained in the use of the telemonitoring equipment at baseline and home visits for practical technical visits were available if needed. The equipment consisted of a sphygmomanometer with it’s memory hooked up to an internet connection. Practices received summary data from the research team once each month, by report, to allow incorporation into clinical records systems. Blood pressure recordings could be accessed by patients via a secure internet site.

In both the telemonitoring and self-monitoring groups, every patient was given an individualized two step self management algorithm to adjust medication according to blood pressure, with each change being discussed with their GP. Each step represented a single medication change whether it be a dose increase or a new medication, decided on after increased readings in two consecutive months all based on the NICE guidelines. If both steps of the 2 step plan are utilized before the 12 months are over, patient returned to the GP to come up with another 2 step plan.

Outcomes

Primary Outcomes

Clinic measured systolic blood pressures after 12 months.

The overall mean blood pressure of the self-monitoring group (137.0 mmHg [SD 16.7]) and telemonitoring groups (136.0 mmHg [SD 16.1]) were lower than the usual care group (140.4 mmHg [SD 16.5]).

The self-monitoring group had statistically significant lower readings than the usual care group (AMD: -3.5; 95%CI -5.8 to -1.2; p=0.0029), as well as the telemonitoring group having statistically significant lower readings that the usual care group (AMD: -4.7; 95%CI -7 to -2.4; p<0.0001). There was no statistically significant difference between the telemonitoring and self-monitoring groups (AMD: -1.2; 95%CI -3.5 to 1.2; p=0.3219).

Secondary Outcomes

Diastolic blood pressure measurements after 6 months and 12 months.

After 6 or 12 months, there was no difference between the groups in diastolic blood pressure (Telemonitoring vs. usual care at 6 months and 12 months, respectively: AMD: -1.2, -1.3; 95%CI -2.4 to -0.01, -2.5 to -0.02; p=0.0482, 0.0482; Self-monitoring vs. usual care at 6 months and 12 months, respectively: AMD: -0.1, -1.5; 95%CI -1.3 to 1.07, -2.7 to -0.2; p=0.8421, 0.0209).

Systolic blood pressure measurements after 6 months.

The systolic blood pressure readings were significantly lower in telemonitoring than usual care after 6 months (AMD: -3.7; 95%CI -5.9 to -1.5; p=0.0012). The systolic blood pressure readings showed no significant difference between self-monitored readings and usual care (AMD: -2.1; 95%CI -4.3 to 0.1; p=0.0584).

Antihypertensive medication titration.

The self-monitoring (AMD: 0.11; 95%CI 0.02 to 0.19; p=0.0129),and telemonitoring groups (AMD: 0.13; 95%CI 0.04 to 0.21; p=0.0038), had more new antihypertensives prescribed in addition to their current medication regimen than the usual care group.

The DDD (defined daily dose) of antihypertensive agents did not increase significantly within the self-monitoring group compared to the usual care group (AMD: 0.19; 95%CI 0.03 to 0.36; p=0.0175). The DDD of antihypertensive agents did have a significant increase in the telemonitoring group compared to the usual group (AMD: 0.31; 95%CI 0.15 to 0.47; p<0.0001).

Tertiary Outcomes

Self-reported adherence, anxiety.

There was no difference in self-reported adherence nor anxiety recorded at 12 months between all the groups.

Adverse effects.

There was no significant difference between groups regarding side effects such as pain, stiff joints, sleep issues, or fatigue.

Nonpharmacologic effects.

The quality of life between patients of each group was not significantly different and weight was not difference between baseline and follow-up in any intervention group or the usual care group.

Criticisms

  • The trial was designed to detect overall cardiovascular outcomes on morbidity and mortality
    • Cardiovascular events were reported in 9 patients in the usual care group, 12 patients in the self-monitoring group, and 11 patients in the telemonitoring group.
    • Only correlations can be made for clinical events from this trial
    • Lower systolic blood pressure values are simply numbers and do not reflect the important outcomes that matter to patients such as the prevention of heart attacks and strokes
      • In order to evaluate the effect on cardiovascular events, the study would have to be extended by 5 or more years
  • GP practice technique differences when regarding implementation of additional antihypertensive medications
    • Since 138 general practice offices were utilized in this study, the inconsistency in prescribing among practitioners at the different offices could skew data
      • An average reading for one patient may have the prescriber adding another medication while that same reading for another patient, a different prescriber may wait to initiate a new antihypertensive agent
    • An improvement would be to have very specific guidelines prescribers must follow to ensure consistency
  • Health literacy
    • Based on reading level and general understanding of self-monitoring blood pressures, there could be variation in how patients respond within each subgroup

Funding

National Institute for Health Research via Programme Grant for Applied Health Research