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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
119
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
Health Centre of Jyväskylä Cooperation Area
Jyväskylä, Finland
Mehiläinen Jyväskylä Occupational Health Services
Jyväskylä, Finland
Central Finland Hospital District (Perusterveydenhuollon liikelaitos Seututerveyskeskus)
Jyväskylä, Finland
Oma Lääkärisi Tikkakoski
Jyväskylä, Finland
Oma Lääkärisi Korpilahti
Jyväskylä, Finland
Sote kuntayhtymä/Perusturvaliikelaitos Saarikka
Saarijärvi, Finland
The proportion of patients achieving the systolic blood pressure target at 12-month follow-up
The proportion of patients (%) achieving systolic office blood pressure (BP) target (\<140 mmHg) and home BP target (\<135 mmHg) are both analyzed separately using mixed effects model. Both office BP and home BP are measured with a validated blood pressure monitoring device (Microlife Watch BP Home A or Microlife Watch BP Home N) after appropriate rest from the left arm with an appropriately sized semi-rigid conical cuff. Office BP is the mean of three measurements separated by 15 seconds. Home BP is measured correspondingly three times in the morning and in the evening on 7 consecutive days at 12 months. Home BP is the mean of all available measurements.
Time frame: 12 months from baseline
Measured medication adherence
Medication adherence is assessed by pharmacy refill data and by self-report strategy (Morisky Medication Adherence Scale, MMAS-8). Tresholds for good adherence are correspondingly (i) Medication possession ratio (MPR) 80 % or more and (ii) MMAS-8 with a score of 6 or more. Both are analyzed separately using generalized mixed effects model. Besides, medication adherence is analyzed as follows: * Persistence: time (days) from the newly initiated medication order to (i) last dispensation before failing to refill within 180 days or (ii) end of follow-up period * Early non-persistence: newly initiated medication order dispensed within 30 days of the initial order with no refills within 180 days * Primary non-adherence: newly initiated medication order not dispensed within 30 days of the initial order
Time frame: 12 months from baseline
Change in systolic and diastolic blood pressure
Both office BP and home BP are measured with a validated blood pressure monitoring device (Microlife Watch BP Home A or Microlife Watch BP Home N) after appropriate rest from the left arm with an appropriately sized semi-rigid conical cuff. Office BP is the mean of three measurements separated by 15 seconds. Home BP is measured correspondingly three times in the morning and evening on 7 consecutive days at 12 months. Home BP is the mean of all available measurements. Change in office BP and home BP are both analyzed separately using generalized mixed effects model. Change in systolic and diastolic blood pressure are as well both analyzed separately using generalized mixed effects model.
Time frame: 12 months from baseline
Hypertension-related use of health care services
Hypertension-related use of health care services (outpatient care and hospital admissions) is assessed by examining participants' electronic health records and with a questionnaire regarding the use of health services other than study centers. Proportion of scheduled clinic appointments attended is also analyzed.
Time frame: 0-12 months from baseline
Perceived quality of life
Perceived quality of life is assessed by EQ-5D-5L questionnaire
Time frame: baseline and 12 months from baseline
The proportion of participants knowing the adequate home BP target
Knowing the target is assessed by questionnaire at baseline and at 12 months. The results are divided into three groups: (i) knows the adequate target (ii) knows the target but it is not adequate (iii) do not know the target. The target is considered adequate if it differs less than 5/3 mmHg from the Finnish national guide lines for treating hypertension (Office BP target \<140/90 mmHg except diabetics \<140/80 mmHg. Home BP target \<135/85 mmHg except diabetics \<135/75 mmHg)
Time frame: baseline and 12 months from baseline
The proportion of patients whose BP target is adequately set
Setting the target is assessed by examining the electric health record at 12 months The results are divided into three groups: (i) written target is set and adequate (ii) written target is set but not adequate and (iii) written target is not set. The target is considered adequate if it differs less than 5/3 mmHg from the national guide lines for treating hypertension (Office BP target \<140/90 mmHg except diabetics \<140/80 mmHg. Home BP target \<135/85 mmHg except diabetics \<135/75 mmHg)
Time frame: 12 months from baseline
The quality and quantity of self-monitored blood pressure
The quality and quantity of self-monitored blood pressure measurements made prior to follow-up period is assessed first at base line. All participants are then equipped with a validated blood pressure monitoring device (Microlife Watch BP Home A or Microlife Watch BP Home N) with a memory space up to 250 measurements. The quality and quantity of self-monitored blood pressure measurements during the follow-up is assessed by examining the memory of every single device at and,the written follow-up form filled up by each participant at 12 months. The target is considered adequate if it differs less than 5/3 mmHg from the national guide lines for treating hypertension (Office BP target \<140/90 mmHg except diabetics \<140/80 mmHg. Home BP target \<135/85 mmHg except diabetics \<135/75 mmHg)
Time frame: baseline and 12 months from baseline
ECG
ECG is taken at baseline (timeframe 6 months before - 1 month after initiation of medication) and at 12 months.
Time frame: baseline and 12 months from baseline
Blood glucose level
Blood glucose level is tested at baseline (timeframe 6 months before - 1 month after initiation of medication) and at 12 months.
Time frame: baseline and 12 months from baseline
Blood cholesterol level
Blood cholesterol level is tested at baseline (timeframe 6 months before - 1 month after initiation of medication) and at 12 months.
Time frame: baseline and 12 months from baseline
Microalbuminuria
The presence of microalbuminuria is tested at baseline (timeframe 6 months before - 1 month after initiation of medication) and at 12 months.
Time frame: baseline and 12 months from baseline
Creatinine level
Creatinine level is tested at baseline (timeframe 6 months before - 1 month after initiation of medication) and at 12 months.
Time frame: baseline and 12 months from baseline
Body mass index
Participant's height and weight are measured by nurse/treating physician and BMI calculated at baseline and at 12 month.
Time frame: baseline and 12 months from baseline
Waist circumference
Participant's waist circumference is measured by nurse/treating physician at baseline and at 12 month.
Time frame: baseline and 12 months from baseline
Exercising habits
Every participant meets a query measuring participants' exercising habits (Kasari -index) at baseline and at 12 months.
Time frame: baseline and 12 months from baseline
Smoking
Every participant meets a query measuring participants' smoking (Heaviness of smoking -index) at baseline and at 12 months.
Time frame: baseline and 12 months from baseline
Alcohol use
Every participant meets a query measuring participants' alcohol use (Audit-c) at baseline and at 12 months.
Time frame: baseline and 12 months from baseline
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