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

Hypertension Clinical Trial

— PERHIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554382
• Other study ID #: PERHIT
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: April 18, 2021

Study information

• Verified date: April 2022
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 971
• Est. completion date: April 18, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Sweden	Solklart vård i Bjuv	Bjuv
Sweden	Wetterhälsan	Jönköping
Sweden	Vårdcentralen Kärna	Linköping
Sweden	Adina Hälsans Vårdcentral Nol	Nol

Sponsors (4)

Lead Sponsor	Collaborator
Region Skane	Clinical Studies Sweden - Forum South, Swedish Heart Lung Foundation, the Kamprad Family Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure	mean of three BP Readings at each timepoint	12 months