Prevalence of Hypertension Using Telemedical Home Blood P... | NCT02355392

Studies
Prevalence of Hypertension Using Telemedical Home Blood Pressure Measurements

NCT02355392

Sponsor

Erling Bjerregaard Pedersen

Status

Completed

Last Update Posted

Feb 4, 2015Estimated

Enrollment

3,159Actual

Phase

Not provided

Conditions

Hypertension

Interventions

Telemedical home blood pressure measurements

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jan 30, 2015

First Submission Date that Met QC Criteria

Jan 30, 2015

First Posted Date

Feb 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2015

Last Update Posted Date

Feb 4, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erling Bjerregaard Pedersen, Professor, Chief Physician, Regional Hospital HolstebroSponsor-Investigator

Lead Sponsor

Erling Bjerregaard PedersenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the prevalence of hypertension among citizens of Holstebro, Denmark aged 55-64 years, including both the well treated, the untreated and the insufficiently treated, and to estimate the prevalence of white coat and masked hypertension using home blood pressure measurements with telemedical data transmission.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,159Actual

Name	Type	Description	Arm Group Labels	Other Names
Telemedical home blood pressure measurements	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Office blood pressure		10 minuttes
Telemedical home blood pressure		3 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 55 to 64 years
Registered address in the municipality of Holstebro
Enrolment at a practice of one of the GPs who had agreed to participate in the study.

Exclusion Criteria:

Unwillingness to participate
Incapability to do home blood pressure measurements

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

A population study in the municipality of Holstebro, which has 57.000 inhabitants. Using the Civil Registration System, we invite all citizens aged 55-64 years.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nikolai Hoffmann-Petersen, MD	Department of Medical Research and Medicine, Holstebro Regional Hospital, Holstebro, Denmark	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26208671	Derived	Hoffmann-Petersen N, Lauritzen T, Bech JN, Pedersen EB. High Prevalence of Hypertension in a Danish Population Telemedical Home Measurement of Blood Pressure in Citizens Aged 55-64 Years in Holstebro County. Am J Hypertens. 2016 Apr;29(4):439-47. doi: 10.1093/ajh/hpv116. Epub 2015 Jul 23.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases