NCT02377960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable hypertension

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

January 27, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2018

Completed
Last Updated

July 11, 2018

Status Verified

July 1, 2018

Enrollment Period

3.1 years

First QC Date

January 15, 2015

Last Update Submit

July 10, 2018

Conditions

HypertensionBlood PressurePatient CompliancePatient AdherenceMedication Adherence

Keywords

SMStext messagemHealthIMB

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months from baseline

Secondary Outcomes (17)

  • Measured medication adherence

    12 months from baseline

  • Change in systolic and diastolic blood pressure

    12 months from baseline

  • Hypertension-related use of health care services

    0-12 months from baseline

  • Perceived quality of life

    baseline and 12 months from baseline

  • The proportion of participants knowing the adequate home BP target

    baseline and 12 months from baseline

  • +12 more secondary outcomes

Other Outcomes (1)

  • The quality of IMB model-based structured initiation of medication for screening of non-compliant patients

    12 months from baseline

Study Arms (3)

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.

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

Behavioral: IMB model-based initiation of antihypertensive medicationBehavioral: 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.

Behavioral: IMB model-based initiation of antihypertensive medicationBehavioral: Tailored SMS-text message support

Interventions

IMB model-based initiation of antihypertensive medicationBEHAVIORAL

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

Also known as: Check list for initiation of antihypertensive medication
An IMB model-based initiation of medicationTailored SMS-text message support
Tailored SMS-text message supportBEHAVIORAL

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.

Also known as: Text message support
An IMB model-based initiation of medicationTailored SMS-text message support
Usual careBEHAVIORAL

Usual care

Also known as: Standard care
Usual care (Reference group)

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Health Centre of Jyväskylä Cooperation Area

Jyväskylä, 40100, Finland

Location

Mehiläinen Jyväskylä Occupational Health Services

Jyväskylä, 40100, Finland

Location

Central Finland Hospital District (Perusterveydenhuollon liikelaitos Seututerveyskeskus)

Jyväskylä, 40620, Finland

Location

Oma Lääkärisi Tikkakoski

Jyväskylä, 41160, Finland

Location

Oma Lääkärisi Korpilahti

Jyväskylä, 41800, Finland

Location

Sote kuntayhtymä/Perusturvaliikelaitos Saarikka

Saarijärvi, 43101, Finland

Location

Related Publications (3)

  • 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.

    PMID: 34530733DERIVED

  • 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.

    PMID: 33769555DERIVED

  • 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.

    PMID: 30567497DERIVED

MeSH Terms

Conditions

HypertensionPatient ComplianceMedication Adherence

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Pekka Mäntyselkä, MD,Prof.

    University of Eastern Finland

    STUDY CHAIR

  • Aapo Tahkola, LM,PHD st.

    Health Centre of Jyväskylä Cooperation Area

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2015

First Posted

March 4, 2015

Study Start

January 27, 2015

Primary Completion

March 6, 2018

Study Completion

March 6, 2018

Last Updated

July 11, 2018

Record last verified: 2018-07

Locations

FI(6)