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NCT Number: NCT03554382

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Solklart vård i Bjuv, Bjuv, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

system to support self-management of hypertension

Other

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

Primary outcomes

  1. Change in blood pressure

    Time frame: 12 months

    mean of three BP Readings at each timepoint

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PERHIT

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 13, 2018
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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