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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Hypertension, High Blood Pressure

Intervention / Treatment
-----------------
* Other: system to support self-management of hypertension


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>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<br>* 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<br>|
| No Intervention: Control<br>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 | mean of three BP Readings at each timepoint | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
person-centred care (PCC), self-efficacy