Check and Support -Enhancing the Treatment of Hypertension in Outpatient Care, a Multicenter Study
NCT ID: NCT02377960
Last Updated: 2018-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
119 participants
INTERVENTIONAL
2015-01-27
2018-03-06
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Usual care (Reference group)
Treatment is leaded by treating physician according to national guide lines with no study-specific medication or clinical appointment protocol.
Usual care
Usual care
An IMB model-based initiation of medication
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
IMB model-based initiation of antihypertensive medication
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
Tailored SMS-text message support
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.
Tailored SMS-text message support
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.
IMB model-based initiation of antihypertensive medication
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
Tailored SMS-text message support
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.
Interventions
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IMB model-based initiation of antihypertensive medication
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
Tailored SMS-text message support
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
Usual care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
75 Years
ALL
No
Sponsors
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Health Centre of Jyväskylä Cooperation Area
UNKNOWN
Central Finland Hospital District
OTHER
Occupational Health Care Työterveys Aalto
UNKNOWN
Mehiläinen Jyväskylä Occupational health services
UNKNOWN
Northern Savo Hospital District
OTHER
Kuopio University Hospital
OTHER
Responsible Party
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Principal Investigators
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Pekka Mäntyselkä, MD,Prof.
Role: STUDY_CHAIR
University of Eastern Finland
Aapo Tahkola, LM,PHD st.
Role: PRINCIPAL_INVESTIGATOR
Health Centre of Jyväskylä Cooperation Area
Locations
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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
Countries
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References
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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.
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.
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.
Other Identifiers
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KUH500SH01
Identifier Type: -
Identifier Source: org_study_id
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