Clinical trial NCT05575453: OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
Official title: OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Home Blood Pressure Monitoring
Digital health
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hypertension is the leading modifiable risk factor for cardiovascular disease and is implicated in half of all strokes and myocardial infarctions. One-third of adults in Scotland have hypertension yet only one-quarter of these have their blood pressure (BP) controlled to target (\<140/90 mmHg). Reasons for the low rate of control are varied but include individuals lack of confidence, knowledge and understanding of the condition and treatment strategy, non-adherence to medication and infrequent BP monitoring. These issues have been compounded by the ongoing COVID-19 pandemic which has brought changes in routine BP screening, access to medical care and chronic disease management in primary and secondary care, shielding of the highest risk groups and a change in health and research focus. Shared decision making and issues around health literacy were highlighted by the Scottish Government Cross Party Group on Heart Disease and Stroke: High Blood Pressure Task Force in 2019. Empowering patients to have a better understanding of their condition and becoming actively involved in the monitoring and management of hypertension may lead to improved patient satisfaction, improved BP control and health outcomes and reduction in the use of primary/secondary care hypertension clinics.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Current attendance at the GBPC

Exclusion Criteria:

* Inability to give informed consent
* Non-English speakers
* No internet access
* Clinic or ambulatory blood pressure ≥180/120 mmHg
* Arm circumference \>42cm
* Inability to perform HBPM
* Inability to use Kvatchii portal
* Pregnancy
* Persistent atrial fibrillation
* Acute cardiovascular event requiring hospitalisation in the previous 3 months
* CKD stage ≥4 or renal dialysis
* Severe or terminal illness limiting study participation

Primary outcomes:
measure: HBPM systolic blood pressure (SBP) area under the curve (AUC)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: HBPM diastolic blood pressure (DBP) under the curve (AUC)
timeFrame: Baseline and 6 months
measure: HBPM systolic blood pressure (SBP) under the curve (AUC)
timeFrame: Baseline and 12 months
measure: HBPM diastolic blood pressure (DBP) under the curve (AUC)
timeFrame: Baseline and 12 months
measure: Change in knowledge of hypertension measured by Blood Pressure Knowledge questionnaire
timeFrame: Baseline, 6 months and 12 months
measure: Change in health literacy measured by BRIEF: Health literacy Screening Tool
timeFrame: Baseline, 6 months and 12 months
measure: Change in quality of life measured by EQ-5D-5L questionnaire
timeFrame: Baseline, 6 months and 12 months
measure: Change in quality of life measured by Patient Health Questionnaire (PHQ-9) questionnaire
timeFrame: Baseline, 6 months and 12 months
measure: Change in quality of life measured by the generalised anxiety disorder 7 item scale (GAD-7)
timeFrame: Baseline, 6 months and 12 months
measure: Change in antihypertensive medicine adherence measured by the Hill-Bone compliance to High Blood Pressure Therapy Scale (HB-HBP)
timeFrame: Baseline, 6 months and 12 months
measure: Change in lifestyle measured by lifestyle questionnaire
timeFrame: Baseline, 6 months and 12 months
measure: Antihypertensive medication changes
timeFrame: Baseline, 6 months and 12 months
measure: Evaluation of the Kvatchii portal measured by system usability scale (SUS)
timeFrame: over the course of 24 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Clinical Research Facility
state: Scotland
Study officials:
affiliation: NHS Greater Glasgow and Clyde
name: Linsay McCallum, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References: