Clinical trial NCT03554382: Efficient Self-management of Chronic Disease Using Health Information Technology - a Study on Hypertension
Official title: PERson-centredness in Hypertension Management Using Information Technology (PERHIT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
High Blood Pressure
Keywords: person-centred care (PCC)
self-efficacy
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: the Kamprad Family Foundation
name: Swedish Heart Lung Foundation
name: Clinical Studies Sweden - Forum South
First posted: 2018-06-13
Enrollment: 971
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in blood pressure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bjuv
country: Sweden
facility: Solklart vård i Bjuv
city: Jönköping
country: Sweden
facility: Wetterhälsan
city: Linköping
country: Sweden
facility: Vårdcentralen Kärna
city: Nol
country: Sweden
facility: Adina Hälsans Vårdcentral Nol
Study officials:
affiliation: Lund University
name: Patrik Midlöv, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.