NCT01525108

Brief Summary

In this study the investigators aim to evaluate the effect of home-based blood pressure measurement with an electronic device on medication adherence and blood pressure control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

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 30, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

6 months

First QC Date

January 30, 2012

Last Update Submit

June 10, 2013

Conditions

Hypertension

Keywords

Medication adherenceBlood pressureHome-based blood pressure measurementBlood Pressure DeterminationBlood Pressure MonitorsBlood Pressure Monitoring, Ambulatory

Outcome Measures

Primary Outcomes (1)

  • Blood pressure-24 weeks

    Blood pressure is measured twice by trained nurses using hand-cuff device at the physician office. (in Hg millimeter)

    Change from baseline(at the point of recruiting) blood pressure at 24 weeks.

Secondary Outcomes (5)

  • Medication adherence-4 weeks

    Change from baseline(at the point of recruiting) medication adherence at 4 weeks

  • Blood pressure- 4 weeks

    Change from baseline(at the point of recruiting) blood pressure at 4 weeks.

  • Blood pressure- 12 weeks

    Change from baseline(at the point of recruiting) blood pressure at 12 weeks.

  • Medication adherence- 12 weeks

    Change from baseline(at the point of recruiting) medication adherence at 12 weeks

  • Medication adherence-24 weeks

    Change from baseline(at the point of recruiting) medication adherence at 24 weeks

Study Arms (2)

Home-based blood pressure monitoring

EXPERIMENTAL
Behavioral: Self monitoring of blood pressure

Usual care

ACTIVE COMPARATOR
Other: Usual Care

Interventions

Self monitoring of blood pressureBEHAVIORAL

Electronic blood pressure device is provided for patients and he/she will be trained to measure blood pressure at home once daily(same time each day). A logbook is also provided to document the daily blood pressure level.

Home-based blood pressure monitoring
Usual CareOTHER

Four visits to the physician's office at 4th, 12th, 24th week in the study period with usual advice giving practice of the staff. At the end of the trial period, an electronic blood pressure device will be given to each patient in this arm.

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ambulatory patients older than 18
  • Patients newly diagnosed as hypertension stage 1
  • Patients previously on antihypertensive treatment but uncontrolled hypertension
  • Patients not possessing electronic self blood pressure measurement device
  • Patients with functional ability to use the device

You may not qualify if:

  • Patients requiring two or more antihypertensive drugs at the start of the study
  • Patients with secondary hypertension
  • Patients cardiovascular comorbidities and other interfering medical conditions
  • Patients with drug contraindication or documented drug allergy
  • Patients with serum creatinine \> 150 microliters
  • Withdrawal criteria:
  • Inadequate therapeutic effect requiring an increase of more than 20% in pre-established number of visits
  • Emergence of adverse drug reactions requiring cessation of medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Mohagheghi's Office

Tehran, Tehran Province, Iran

Location

Related Publications (1)

  • Hosseininasab M, Jahangard-Rafsanjani Z, Mohagheghi A, Sarayani A, Rashidian A, Javadi M, Ahmadvand A, Hadjibabaie M, Gholami K. Self-monitoring of blood pressure for improving adherence to antihypertensive medicines and blood pressure control: a randomized controlled trial. Am J Hypertens. 2014 Nov;27(11):1339-45. doi: 10.1093/ajh/hpu062. Epub 2014 Apr 26.

    PMID: 24771706DERIVED

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Kheirollah Gholami, M.Sc,PharmD

    Tehran University of Medical Sciences

    STUDY CHAIR

  • Zahra Jahangard-Rafsanjani, PharmD

    Tehran University of Medical Sciences

    STUDY DIRECTOR

  • Arash Rashidian, M.D, Ph.D

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2012

First Posted

February 2, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2012

Study Completion

March 1, 2013

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

IR(1)