NCT02531347

Brief Summary

The purpose of the study is to compare antihypertensive treatment based on either conventional blood pressure measurements or telemedical home blood pressure measurements. Hypothesis is that telemedical treatment of hypertension is more effective in lowering blood pressure, is more cost-effective and provides better quality of life.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
375

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable hypertension

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2015

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

3.8 years

First QC Date

August 20, 2015

Last Update Submit

August 21, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood pressure reduction

    Difference in daytime ambulatory blood pressure from baseline to followup between intervention and control group

    3 month

Secondary Outcomes (1)

  • Number of patients reaching target blood pressure

    3 month

Study Arms (2)

Telemedical blood pressure monitoring

EXPERIMENTAL

Telemedical home blood pressure measurements for three days every second week. The average of all measures excluding day one is electronically transmitted to the General Practitioners. Following communication primarily by email or telephone.

Behavioral: Telemedical home blood pressure measurements

Conventional blood pressure monitoring

ACTIVE COMPARATOR

Conventional blood pressure monitoring

Behavioral: Conventional blood pressure monitoring

Interventions

Telemedical blood pressure monitoring
Conventional blood pressure monitoring

Eligibility Criteria

Age55 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 55 to 64 years
  • Registered address in the Municipality of Holstebro
  • Enrolment at a practice of one of the general practitioners who had agreed to participate in the study
  • Telemedical home blood pressure measurement with ≥12 measurements on day 2 and 3.
  • Elevated home blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80)
  • Hypertension confirmed by daytime ambulatory blood pressure ≥135/85 (if diagnosed diabetes, chronic kidney disease or prior stroke ≥130/80)
  • ECG verified sinus rhythm

You may not qualify if:

  • Unwillingness to participate
  • Normotension
  • Withdrawal of consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hoffmann-Petersen N, Lauritzen T, Bech JN, Pedersen EB. Short-term telemedical home blood pressure monitoring does not improve blood pressure in uncomplicated hypertensive patients. J Hum Hypertens. 2017 Feb;31(2):93-98. doi: 10.1038/jhh.2016.43. Epub 2016 Jun 23.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Nikolai Hoffmann-Petersen, MD

    Department of Medical Research and Medicine, Holstebro Regional Hospital, Holstebro, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Chief Physician

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 24, 2015

Study Start

March 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 24, 2015

Record last verified: 2015-08