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

Region Skane

Status: Completed

Conditions: Hypertension; High Blood Pressure

Treatments: Other: system to support self-management of hypertension

Study type: Interventional

Funder types: Other

Identifiers

NCT03554382

PERHIT

Details and patient eligibility

About

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.

Enrollment: 971 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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971 participants in 2 patient groups

intervention

Experimental group

Description:

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.

Treatment:

Other: system to support self-management of hypertension

Control

No Intervention group

Description:

No study intervention will be made in the control group; they will receive "treatment as usual".