Check and Support -Enhancing the Treatment of Hypertension in Outpatient Care, a Multicenter Study
Condition: Hypertension; Blood Pressure; Patient Compliance; Patient Adherence; Medication Adherence
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      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.
    

Detailed 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).
    

Intervention name(s): IMB model-based initiation of antihypertensive medication; Tailored SMS-text message support; Usual care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 1.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; 2.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.; Usual care
Other intervention name(s): Check list for initiation of antihypertensive medication; Text message support; Standard care
Intervention MeSH terms: Antihypertensive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: SMS; text message; mHealth; IMB