Clinical trial NCT02377960: Check and Support -Enhancing the Treatment of Hypertension in Outpatient Care, a Multicenter Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Blood Pressure
Patient Compliance
Patient Adherence
Medication Adherence
Keywords: SMS
text message
mHealth
IMB
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Health Centre of Jyväskylä Cooperation Area
name: Central Finland Hospital District
name: Occupational Health Care Työterveys Aalto
name: Mehiläinen Jyväskylä Occupational health services
name: Northern Savo Hospital District
First posted: 2015-03-04
Enrollment: 119
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of patients achieving the systolic blood pressure target at 12-month follow-up
timeFrame: 12 months from baseline
Secondary outcomes:
measure: Measured medication adherence
timeFrame: 12 months from baseline
measure: Change in systolic and diastolic blood pressure
timeFrame: 12 months from baseline
measure: Hypertension-related use of health care services
timeFrame: 0-12 months from baseline
measure: Perceived quality of life
timeFrame: baseline and 12 months from baseline
measure: The proportion of participants knowing the adequate home BP target
timeFrame: baseline and 12 months from baseline
measure: The proportion of patients whose BP target is adequately set
timeFrame: 12 months from baseline
measure: The quality and quantity of self-monitored blood pressure
timeFrame: baseline and 12 months from baseline
measure: ECG
timeFrame: baseline and 12 months from baseline
measure: Blood glucose level
timeFrame: baseline and 12 months from baseline
measure: Blood cholesterol level
timeFrame: baseline and 12 months from baseline
measure: Microalbuminuria
timeFrame: baseline and 12 months from baseline
measure: Creatinine level
timeFrame: baseline and 12 months from baseline
measure: Body mass index
timeFrame: baseline and 12 months from baseline
measure: Waist circumference
timeFrame: baseline and 12 months from baseline
measure: Exercising habits
timeFrame: baseline and 12 months from baseline
measure: Smoking
timeFrame: baseline and 12 months from baseline
measure: Alcohol use
timeFrame: baseline and 12 months from baseline
Other outcomes:
measure: The quality of IMB model-based structured initiation of medication for screening of non-compliant patients
timeFrame: 12 months from baseline
Locations:
city: Jyväskylä
country: Finland
facility: Health Centre of Jyväskylä Cooperation Area
city: Jyväskylä
country: Finland
facility: Mehiläinen Jyväskylä Occupational Health Services
city: Jyväskylä
country: Finland
facility: Central Finland Hospital District (Perusterveydenhuollon liikelaitos Seututerveyskeskus)
city: Jyväskylä
country: Finland
facility: Oma Lääkärisi Tikkakoski
city: Jyväskylä
country: Finland
facility: Oma Lääkärisi Korpilahti
city: Saarijärvi
country: Finland
facility: Sote kuntayhtymä/Perusturvaliikelaitos Saarikka
Study officials:
affiliation: University of Eastern Finland
name: Pekka Mäntyselkä, MD,Prof.
role: STUDY_CHAIR
affiliation: Health Centre of Jyväskylä Cooperation Area
name: Aapo Tahkola, LM,PHD st.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tahkola A, Korhonen P, Kautiainen H, Niiranen T, Mantyselka P. The impact of antihypertensive treatment initiation on health-related quality of life and cardiovascular risk factor levels: a prospective, interventional study. BMC Cardiovasc Disord. 2021 Sep 16;21(1):444. doi: 10.1186/s12872-021-02252-7.
citation: Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.
citation: Tahkola A, Korhonen P, Kautiainen H, Niiranen T, Mantyselka P. Feasibility of a checklist in treating hypertension in primary care - base line results from a cluster-randomised controlled trial (check and support). BMC Cardiovasc Disord. 2018 Dec 19;18(1):240. doi: 10.1186/s12872-018-0963-5.