AzTrials
AzTrials

HypertensionPERHITNCT03554382

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

A study testing system to support self-management of hypertension in people with Hypertension and High Blood Pressure, run by Region Skane at 4 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, High Blood Pressure
What is being tested?
system to support self-management of hypertension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
971 participants
Where
4 sitesSweden
Study dates
1 Oct 2018to 18 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Sweden4 sites

  • Solklart vård i Bjuv

    Bjuv

  • Wetterhälsan

    Jönköping

  • Vårdcentralen Kärna

    Linköping

  • Adina Hälsans Vårdcentral Nol

    Nol

Other trials in Sweden

About this study

Official title: 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.

Read more

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.

Being tested
system to support self-management of hypertension
Keywords
person-centred care (PCC), self-efficacy
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • system to support self-management of hypertensionOther

    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

Study groups in NCT03554382
Study groupRoleWhat they receive
interventionExperimentalDaily 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.
Receives: Other: system to support self-management of hypertension
ControlNo interventionNo study intervention will be made in the control group; they will receive "treatment as usual".

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in blood pressure

    mean of three BP Readings at each timepoint

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2018
  2. Study start1 Oct 2018
  3. Primary completion20 Jan 2021
  4. Study completion18 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomization to study groups occurs after completion of informed consent, baseline assessments and questionnaires. Patients are randomly assigned in a 1:1 ratio to either the intervention group or the control group. The CONSORT-EHEALTH checklist will be followed.
Masking
None (open label)
Enrolment
971 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03554382
Sponsor's protocol ID
PERHIT
Acronym
PERHIT
Status last verified
Jan 2025
First submitted
31 May 2018
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hermansson-Borrebaeck R, Fors A, Bengtsson U, Kjellgren K, Calling S, Midlov P. Self-Efficacy in Hypertension Management Using e-Health Technology: A Randomized Controlled Trial in Primary Care. J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14981. doi: 10.1111/jch.14981.

    PubMed 39835832

  • Ekholm M, Andersson U, Nilsson PM, Kjellgren K, Midlov P. Evaluation of self-monitoring of blood pressure in the PERHIT study and the impact on glomerular function. Blood Press. 2024 Dec;33(1):2399565. doi: 10.1080/08037051.2024.2399565. Epub 2024 Sep 9.

    PubMed 39250514

  • Vestala H, Bendtsen M, Midlov P, Kjellgren K, Eldh AC. Is patient participation in hypertension care based on patients' preferences? A cross-sectional study in primary healthcare. Eur J Cardiovasc Nurs. 2024 Dec 16;23(8):903-911. doi: 10.1093/eurjcn/zvae085.

    PubMed 38805264

  • Andersson U, Nilsson PM, Kjellgren K, Harris K, Chalmers J, Ekholm M, Midlov P. Variability in home blood pressure and its association with renal function and pulse pressure in patients with treated hypertension in primary care. J Hum Hypertens. 2024 Mar;38(3):212-220. doi: 10.1038/s41371-023-00874-2. Epub 2023 Nov 15.

    PubMed 37968455

  • Andersson U, Nilsson PM, Kjellgren K, Hoffmann M, Wennersten A, Midlov P. PERson-centredness in Hypertension management using Information Technology: a randomized controlled trial in primary care. J Hypertens. 2023 Feb 1;41(2):246-253. doi: 10.1097/HJH.0000000000003322. Epub 2022 Nov 18.

    PubMed 36394295

  • Andersson U, Bengtsson U, Ranerup A, Midlov P, Kjellgren K. Patients and Professionals as Partners in Hypertension Care: Qualitative Substudy of a Randomized Controlled Trial Using an Interactive Web-Based System Via Mobile Phone. J Med Internet Res. 2021 Jun 3;23(6):e26143. doi: 10.2196/26143.

    PubMed 34081021

Questions about this trial

What is this clinical trial studying?

A study testing system to support self-management of hypertension in people with Hypertension and High Blood Pressure, run by Region Skane at 4 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in blood pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03554382, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in