N/A Completed N=3,071 Randomized Treatment

Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure

Hypertension

Source: ClinicalTrials.gov NCT02996565 ↗

Enrolled (actual)

3,071

Serious AEs

2.1%

Results posted

Sep 2024

Primary outcomePrimary: Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg) — -17.97; -18.72 mm Hg — p=0.45

Summary

This pragmatic trial will compare two team-based care models for managing hypertension, Best Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care system in Minnesota. Clinics in the study are randomized to offer one of the two treatment models to participants with uncontrolled hypertension. The investigators aim to determine a) whether one model is more effective than the other for lowering patient's blood pressure and b) which model patients prefer.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Systolic Blood Pressure Between Baseline and 12 Months (mm Hg)	-17.97; -18.72	0.45
SECONDARY Change in Diastolic BP Between Baseline and 12 Months (mm Hg)	-9.98; -9.70	0.64
SECONDARY Number of Participants Who Reporting Monitoring BP at Least 2 Times Per Week at Six Months Follow-up	189; 265	<0.001 sig
SECONDARY Number of Participants Who Report High Level of Satisfaction With Hypertension Care at Six Months.	205; 241	0.03 sig
SECONDARY Number of Participants Who Are Current Smokers at Twelve Months	273; 199	0.73
SECONDARY Number of Participants Reporting Cough as a Side Effect of Antihypertensive Medications at Six Months	202; 212	0.08
SECONDARY Number of Participants Reporting Dizziness as a Side Effect of Antihypertensive Medication at Six Months	247; 232	0.18
SECONDARY Number of Participants Reporting Frequent Urination as a Side Effect of Antihypertensive Medication at Six Months	331; 293	0.77
SECONDARY Number of Participants Reporting Leg/Foot Swelling as a Side Effect of Antihypertensive Medication at Six Months	247; 208	0.32
SECONDARY Number of Participants Reporting Sexual Symptoms as a Side Effect of Antihypertensive Medication at Six Months	174; 132	0.62
SECONDARY Number of Participants Reporting Tiredness as a Side Effect of Antihypertensive Medication at Six Months	437; 376	0.87
SECONDARY Number of Participants Who Report Decreasing Salt as Helpful for BP Self-management at Six Months	274; 242	0.51
SECONDARY Number of Participants Who Report Limiting Alcohol as Helpful for BP Self-management at Six Months	147; 138	0.41
SECONDARY Number of Participants Who Report Physical Activity as Helpful for BP Self-management at Six Months	291; 256	0.18
SECONDARY Number of Participants Who Report Reducing Stress as Helpful for BP Self-management at Six Months	278; 243	0.31
SECONDARY Number of Participants Who Report Watching Weight as Helpful for BP Self-management at Six Months	290; 249	0.56
SECONDARY Number of Participants Identifying Clinic Visits as BP Care Burden at Six Months	196; 149	0.08
SECONDARY Number of Participants Identifying Cost of Care or Medications as BP Care Burden at Six Months	188; 134	0.32
SECONDARY Number of Participants Reporting Increasing Physical Activity as BP Care Burden at Six Months	236; 242	0.09
SECONDARY Number of Participants Reporting Lifestyle Changes as BP Care Burden at Six Months	251; 192	0.77
SECONDARY Number of Participants Reporting Measuring BP as BP Care Burden at Six Months	158; 164	0.09
SECONDARY Number of Participants Reporting Phone Visits as BP Care Burden at Six Months	94; 66	0.02 sig
SECONDARY Number of Participants Reporting Scheduling Visits as BP Care Burden at Six Months	186; 127	0.006 sig
SECONDARY Number of Participants Reporting Time Away From Work as BP Care Burden at Six Months	159; 92	0.06
SECONDARY Number of Participants Reporting High Confidence in Reporting Contacting Care Team at Six Months Confidence in Managing Blood Pressure: Contact Care Team	481; 467	0.65
SECONDARY Number of Participants Reporting High Confidence in Keeping BP Below Target at Six Months	242; 252	0.83
SECONDARY Number of Participants Reporting High Confidence in Knowing BP Target Numbers at Six Months	437; 465	0.41
SECONDARY Number of Participants Reporting High Confidence in Measuring BP at Home at Six Months	376; 412	0.40
SECONDARY Number of Participants Reporting High Confidence in Taking BP Medications at Six Months	564; 532	0.74
SECONDARY Number of Participants With Statin Addition at 12 Months	162; 151	0.71

Eligibility Criteria

Inclusion Criteria

Hypertension diagnosis code in medical record, twice in last 24 months
Attends study clinic for primary care visit within study period with uncontrolled blood pressure
Systolic blood pressure >=150 mm Hg or Diastolic blood pressure >=95 mm Hg at current visit
Systolic blood pressure >=150 mm Hg or Diastolic blood pressure >=95 mm Hg at most recent previous visit

Exclusion Criteria

Pregnancy
End Stage Kidney Disease
Patients in hospice care and patients who permanently reside in a nursing home

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02996565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.