Efficient Self-management of Chronic Disease Using Health Information Technology - a Study on Hypertension (PERHIT)

April 27, 2022 updated by: Region Skane

PERson-centredness in Hypertension Management Using Information Technology (PERHIT) Study

Background:

Hypertension is an increasing global problem and measures are needed against the emerging hypertensive burden. Management of the risk factor hypertension consists of medical treatment in conjunction with lifestyle adjustment, whereby lifestyle adjustment is the preventive cornerstone but has also been proven to contribute to BP reduction among those already receiving medical drug treatments. Non-adherence is a significant barrier to successful hypertension management.

Goal:

To improve management of hypertension in daily life from a person-centred perspective, utilizing information and communication technology, and further to decrease complications of hypertension. To increase the proportion of persons with hypertension obtaining a BP goal =<140/90 mmHg and to conduct a health economic evaluation of our intervention.

Plan:

The investigators will conduct a multi-centre randomized controlled trial in 36 primary care centres in three counties in Sweden. There will be approximaely 430 patients in each group. BP will be measured in a standardized manner, laboratory tests taken and questionnaires answered at baseline, after eight weeks and after a year in both the intervention and the control group. Register data on health care resource one year before baseline and for the full study period will be retrieved for participants in both study groups.

Singificance:

The intervention is expected to improve adherence to treatment and a significant lowering of the blood pressure. Hospitalization rates are lower among persons with hypertension that adheres to their medication. By improving treatment of hypertension the hope is to decrease complications and morbidity due to hypertension and thereby hospitalization and health care costs. Due to the generic nature of the technology involved, the self-management system can easily be adapted to monitor other chronic conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

971

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Bjuv, Sweden
        • Solklart vård i Bjuv
      • Jönköping, Sweden
        • Wetterhälsan
      • Linköping, Sweden
        • Vårdcentralen Kärna
      • Nol, Sweden
        • Adina Hälsans Vårdcentral Nol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of hypertension
  • On treatment with at least one antihypertensive drug
  • Understanding of Swedish in order to be able to provide informed consent and to make use of the mobile phone based self-management support system.
  • Mobile phone (patients will use their own mobile, but have the possibility to borrow one if needed)
  • Patient at a primary healthcare centre in any of four participating healthcare regions in Sweden (Skåne, Västra Götaland, Östergötland, and Jönköping)

Exclusion Criteria:

  • Secondary hypertension
  • Terminal illness
  • Pregnancy-induced hypertension
  • Cognitive impairment
  • Impaired vision (not able to read messages on mobile phone)
  • Psychotic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
Daily use of interactive mobile phone-based system to support self-management of hypertension: a) relevant items on drug side effects related to patient's drug regimen; and b) blood pressure.
Other: system to support self-management of hypertension
The patients are provided with a home BP monitor. Thereafter they will be asked to use the self-management support system and self-report, once daily in the evening, via their own mobile phone during eight weeks. At each occasion, the patients first answer the questions on wellbeing, symptoms, lifestyle, medication intake and side effects and then measure their BP and pulse, and when these data (mean of three readings) are input into the mobile phone, they automatically register in the database. During intervention the paient has regular access to self-reported data via graphs
No Intervention: Control
No study intervention will be made in the control group; they will receive "treatment as usual".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood pressure
Time Frame: 12 months
mean of three BP Readings at each timepoint
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Collaborators

Swedish Heart Lung Foundation
Clinical Studies Sweden - Forum South
the Kamprad Family Foundation

Investigators

  • Principal Investigator: Patrik Midlöv, MD, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

January 20, 2021

Study Completion (Actual)

April 18, 2021

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 27, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERHIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on system to support self-management of hypertension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe