Check and Support -Enhancing the Treatment of Hypertension in Outpatient Care, a Multicenter Study

Kuopio University Hospital

Status: Completed

Conditions: Hypertension; Medication Adherence; Patient Compliance; Patient Adherence; Blood Pressure

Treatments: Behavioral: IMB model-based initiation of antihypertensive medication; Behavioral: Usual care; Behavioral: Tailored SMS-text message support

Study type: Interventional

Funder types: Other

Identifiers

NCT02377960

KUH500SH01

Details and patient eligibility

About

The purpose of this pragmatic multi-centre, cluster randomized controlled trial is to test the effectiveness of tailored SMS-text message support combined with an information-motivation-behavioral skills (IMB) model-based initiation of medication in helping outpatient care patients with hypertension to achieve blood pressure target and to enhance medication adherence.

Full description

Background

Usual blood pressure is strongly related to vascular and overall mortality and high blood pressure is globally the leading risk factor for cardiovascular and related diseases. It is also well established that pharmacologic blood pressure reduction prevents cardiovascular events and deaths in persons with hypertension.

Today's physicians have plenty of knowledge and multiple effective and safety tools to treat hypertension but still majority of patients with antihypertensive medication do not achieve the blood pressure target. Poor medication adherence has been widely accepted to be the most important factor in failing to control hypertension and even 50% of hypertensive patients quit the antihypertensive medication during the first year of medication.

Numerous interventions to enhance medication adherence have been developed but even though, an intervention effective, simple and low cost enough to be carried out wide-scale in non-research settings is still to be found.

Objectives

To test whether a tailored SMS-text message support combined with an IMB model-based initiation of medication will increase the proportion of patients achieving the systolic blood pressure target at 12-month follow-up compared to usual care.

Additional objectives include investigating whether the intervention have effect on

• Medication adherence
• Systolic and diastolic blood pressure level
• Hypertension-related use of health care services
• Blood glucose, blood cholesterol, microalbuminuria, creatinine, ECG, body mass index, waist circumference exercising habits, smoking and alcohol use
• Perceived quality of life at base line and at 12-month follow-up
• Setting (physicians) and knowing (participants) an adequate BP target

And, besides

Detecting the participants who especially benefit from intervention

• Analyzing the quality and quantity of self-monitored BP and
• Assessing whether the IMB model-based structured initiation of medication can be used for screening of non-compliant patients and directing resources more accurately to them
• Collecting and analyzing participants' and physicians' feedback for future development of intervention

Study design

Pragmatic randomized controlled multicenter trial. The eight study centers are grouped to comparable pairs and randomized to function as intervention and control sites (2-cluster design).

Enrollment: 119 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A clinical diagnosis of hypertension
• About to start medication for hypertension for the first time
• Aged 30-75 years
• Must own a mobile phone
• Must be able to read text messages
• Must be able to master own medication
• Must be able to perform home BP measurements
• Must agree in using electric drug prescription (standard in Finnish health care)

Exclusion criteria

• Having or is suspected to have depression or psychosis
• Serious disease, which is evaluated to have an impact on life expectancy
• Atrial flutter or atrial fibrillation
• Previous history of antihypertensive medication
• Pregnancy
• Not willing to give informed consent and take part in the study
• Systolic BP more than 200 mmHg
• Diastolic BP more than 120 mmHg
• Sudden onset or worsening of hypertension
• Clinical signs of kidney disease: proteinuria (du-prot > 500 mg), glomerulus filtration rate (eGFR) less than 45 ml/min or hypokalemia

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 3 patient groups

Usual care (Reference group)

Active Comparator group

Description:

Treatment is leaded by treating physician according to national guide lines with no study-specific medication or clinical appointment protocol.

Treatment:

Behavioral: Usual care

An IMB model-based initiation of medication

Experimental group

Description:

In addition to usual care, participants allocated to intervention group will receive An IMB model-based initiation of medication i.e. a nine-point check list to be fulfilled by physician and patient together when ordering the antihypertensive medication for the first time

Treatment:

Behavioral: Tailored SMS-text message support

Behavioral: IMB model-based initiation of antihypertensive medication

Tailored SMS-text message support

Experimental group

Description:

Tailored SMS-text message support for the first 12 months of medication. At the beginning (2 weeks), text messages are send on daily basis and focused on medications-reminders and coping with potential side-effects of medication. After that, text messages will be sent less often and the focus will change to keeping up with medication and reminding of importance of performing adequate home BP self-monitoring, achieving the BP target and attending clinical appointments.

Treatment:

Behavioral: Tailored SMS-text message support

Behavioral: IMB model-based initiation of antihypertensive medication