An Interventional Multidisciplinary Approach to Individualize Blood Pressure Treatment (IDA)

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Uncontrolled Hypertension

Treatments: Device: Home blood pressure monitoring; Diagnostic Test: Therapeutic drug monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03209154

2017/6534

Details and patient eligibility

About

The aim of the study is to investigate and explore the most important aspects of drug-adherence in the treatment of hypertension in order to improve treatment and blood pressure control, implying that new knowledge will reduce morbidity and mortality.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Uncontrolled hypertension
• A stable medication regimen for at least 4 weeks of ≥ 2 antihypertensive agents
• No planned changes in antihypertensive drugs

Exclusion criteria

• Withdrawal of consent
• 24-h systolic ambulatory blood pressure >/= 170 mmHg
• Patients with inadequate Norwegian language skills
• Positive pregnancy test
• Known alcohol or drug abuse
• estimated glomerular filtration rate <30 mL/min/1.73m2
• Albumin/creatinin ratio >300 mg/mmol
• Any reason why, in the opinion of the investigator, the patient should not participate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

Study Group

Experimental group

Description:

Study Group intervention: Therapeutic drug monitoring.

Treatment:

Diagnostic Test: Therapeutic drug monitoring

Control Group

Active Comparator group

Description:

Control Group intervention: No intervention first 3 months. After 3 months of follow-up, half of the patients in the Control Group will be randomized to perform home blood pressure monitoring as an intervention. No intervention in the other half.

Treatment:

Device: Home blood pressure monitoring