Hypertension Clinical Trial
Official title:
Check and Support -Pragmatic Randomized Controlled Study of the Effectiveness of 12 Month SMS-Text Message Support and IMB-based Initiation of Medication in Adults With Hypertension for Better Blood Pressure Control and Medication Adherence
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.
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).
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