OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

Study Overview
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Brief Summary
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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.

Official Title
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OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

Conditions
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Hypertension

Intervention / Treatment
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* Other: Kvatchii Portal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kvatchii Portal<br>The intervention group will be given access to the Kvatchii portal and home blood pressure monitor | Other: Kvatchii Portal<br>* Online education portal<br>|
| No Intervention: Usual Care<br>The control group will not have access to the portal but will be provided with home blood pressure monitor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBPM systolic blood pressure (SBP) area under the curve (AUC) | HBPM systolic blood pressure (SBP) area under the curve (AUC) | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBPM diastolic blood pressure (DBP) under the curve (AUC) | HBPM diastolic blood pressure (DBP) under the curve (AUC) | Baseline and 6 months | 
| HBPM systolic blood pressure (SBP) under the curve (AUC) | HBPM systolic blood pressure (SBP) under the curve (AUC) | Baseline and 12 months | 
| HBPM diastolic blood pressure (DBP) under the curve (AUC) | HBPM diastolic blood pressure (DBP) under the curve (AUC) | Baseline and 12 months | 
| Change in knowledge of hypertension measured by Blood Pressure Knowledge questionnaire | True/false questions, 20 items, score 0-20 with higher indicating greater knowledge | Baseline, 6 months and 12 months | 
| Change in health literacy measured by BRIEF: Health literacy Screening Tool | 4 items, score 0-20 with higher score indicating greater health literacy | Baseline, 6 months and 12 months | 
| Change in quality of life measured by EQ-5D-5L questionnaire | 25 items in 5 domains, health state defined by combining one level from each of the 5 domains of the questionnaires. Lower score indicates lower levels of health problems. Visual scale scored out of 100 with higher score indicating better health. | Baseline, 6 months and 12 months | 
| Change in quality of life measured by Patient Health Questionnaire (PHQ-9) questionnaire | 9 items, score 0-27 with higher score indicating greater severity of depression | Baseline, 6 months and 12 months | 
| Change in quality of life measured by the generalised anxiety disorder 7 item scale (GAD-7) | 7 items, score 0-21 with higher score indicating greater anxiety | Baseline, 6 months and 12 months | 
| Change in antihypertensive medicine adherence measured by the Hill-Bone compliance to High Blood Pressure Therapy Scale (HB-HBP) | 14 items, score 0-56 with higher score indicating higher compliance | Baseline, 6 months and 12 months | 
| Change in lifestyle measured by lifestyle questionnaire | 13 items, lower score indicating poorer lifestyle | Baseline, 6 months and 12 months | 
| Antihypertensive medication changes | Number of antihypertensive medication changes measured by number of medicines altered from last visit | Baseline, 6 months and 12 months | 
| Evaluation of the Kvatchii portal measured by system usability scale (SUS) | 10 items, score 0-100 with higher score indicating better usability | over the course of 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Home Blood Pressure Monitoring, Digital health