HypertensionNCT02377960
Check and Support -Enhancing the Treatment of Hypertension in Outpatient Care, a Multicenter Study
A study testing IMB model-based initiation of antihypertensive medication and Tailored SMS-text message support in people with Hypertension and Blood Pressure, run by Kuopio University Hospital at 6 sites in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Hypertension, Blood Pressure, Patient Compliance
- What is being tested?
- IMB model-based initiation of antihypertensive medication and Tailored SMS-text message support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 6 sitesFinland
- Study dates
- 27 Jan 2015to 6 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Finland6 sites
Health Centre of Jyväskylä Cooperation Area
Jyväskylä, 40100
Mehiläinen Jyväskylä Occupational Health Services
Jyväskylä, 40100
Central Finland Hospital District (Perusterveydenhuollon liikelaitos Seututerveyskeskus)
Jyväskylä, 40620
Oma Lääkärisi Tikkakoski
Jyväskylä, 41160
Oma Lääkärisi Korpilahti
Jyväskylä, 41800
Sote kuntayhtymä/Perusturvaliikelaitos Saarikka
Saarijärvi, 43101
About this 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
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.
Read the 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).
- Being tested
- IMB model-based initiation of antihypertensive medication, Tailored SMS-text message support, Usual care
- Keywords
- SMS, text message, mHealth, IMB
- Medical subject headings
- Hypertension, Patient Compliance, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMB model-based initiation of antihypertensive medicationBehavioural
Also called Check list for 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 supportBehavioural
Also called 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 careBehavioural
Also called Standard care
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Usual care (Reference group) | Active comparator | Treatment is leaded by treating physician according to national guide lines with no study-specific medication or clinical appointment protocol. Receives: Behavioral: Usual care |
| An IMB model-based initiation of medication | Experimental | 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 Receives: Behavioral: IMB model-based initiation of antihypertensive medication; Behavioral: Tailored SMS-text message support |
| Tailored SMS-text message support | Experimental | 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. Receives: Behavioral: IMB model-based initiation of antihypertensive medication; Behavioral: Tailored SMS-text message support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months from baseline
Secondary outcomes (17)
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
Measured: 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.
Measured: 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.
Measured: 0-12 months from baseline
Perceived quality of life
Perceived quality of life is assessed by EQ-5D-5L questionnaire
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 12 months from baseline
Waist circumference
Participant's waist circumference is measured by nurse/treating physician at baseline and at 12 month.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start27 Jan 2015
- Primary completion6 Mar 2018
- Study completion6 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Health Centre of Jyväskylä Cooperation Area, Central Finland Hospital District, Occupational Health Care Työterveys Aalto, Mehiläinen Jyväskylä Occupational health services, Northern Savo Hospital District
- Responsible party
- Sponsor
- Investigators
- Pekka Mäntyselkä, MD,Prof., Study chair, University of Eastern FinlandAapo Tahkola, LM,PHD st., Principal investigator, Health Centre of Jyväskylä Cooperation Area
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377960
- Sponsor's protocol ID
- KUH500SH01
- Status last verified
- Jul 2018
- First submitted
- 15 Jan 2015
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34530733Palmer 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.
PubMed 33769555Tahkola 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.
PubMed 30567497
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02377960
- Acronym / sponsor ID
- KUH500SH01
- Keywords
- SMS, text message, mHealth, IMB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Health Centre of Jyväskylä Cooperation Area, Central Finland Hospital District, Occupational Health Care Työterveys Aalto, Mehiläinen Jyväskylä Occupational health services, Northern Savo Hospital District
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 6 Mar 2018 (actual)
- Study completion
- 6 Mar 2018 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care (Reference group) | Active comparator | Behavioral: Usual careTreatment is leaded by treating physician according to national guide lines with no study-specific medication or clinical appointment protocol. |
| An IMB model-based initiation of medication | Experimental | Behavioral: IMB model-based initiation of antihypertensive medication, Behavioral: Tailored SMS-text message supportIn 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 |
| Tailored SMS-text message support | Experimental | Behavioral: IMB model-based initiation of antihypertensive medication, Behavioral: Tailored SMS-text message supportTailored 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMB model-based initiation of antihypertensive medicationAlso: Check list for initiation of antihypertensive medication1.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 | Behavioural | An IMB model-based initiation of medication, Tailored SMS-text message support |
| Tailored SMS-text message supportAlso: Text message support2.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. | Behavioural | An IMB model-based initiation of medication, Tailored SMS-text message support |
| Usual careAlso: Standard careUsual care | Behavioural | Usual care (Reference group) |
Primary outcome
The proportion of patients achieving the systolic blood pressure target at 12-month follow-up
Time frame: 12 months from baseline
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.
17 secondary outcomes
Measured medication adherence
Time frame: 12 months from baseline
Change in systolic and diastolic blood pressure
Time frame: 12 months from baseline
Hypertension-related use of health care services
Time frame: 0-12 months from baseline
Perceived quality of life
Time frame: baseline and 12 months from baseline
The proportion of participants knowing the adequate home BP target
Time frame: baseline and 12 months from baseline
The proportion of patients whose BP target is adequately set
Time frame: 12 months from baseline
The quality and quantity of self-monitored blood pressure
Time frame: baseline and 12 months from baseline
ECG
Time frame: baseline and 12 months from baseline
Blood glucose level
Time frame: baseline and 12 months from baseline
Blood cholesterol level
Time frame: baseline and 12 months from baseline
Microalbuminuria
Time frame: baseline and 12 months from baseline
Creatinine level
Time frame: baseline and 12 months from baseline
Body mass index
Time frame: baseline and 12 months from baseline
Waist circumference
Time frame: baseline and 12 months from baseline
Exercising habits
Time frame: baseline and 12 months from baseline
Smoking
Time frame: baseline and 12 months from baseline
Alcohol use
Time frame: baseline and 12 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Derived from this study: PubMed 34530733Tahkola 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.
- Derived from this study: PubMed 33769555Palmer 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.
- Derived from this study: PubMed 30567497Tahkola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pekka Mäntyselkä, MD,Prof. study chair
University of Eastern Finland
Aapo Tahkola, LM,PHD st. principal investigator
Health Centre of Jyväskylä Cooperation Area
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMB model-based initiation of antihypertensive medication and Tailored SMS-text message support in people with Hypertension and Blood Pressure, run by Kuopio University Hospital at 6 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients achieving the systolic blood pressure target at 12-month follow-up (time frame: 12 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377960, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.