OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Kvatchii Portal The intervention group will be given access to the Kvatchii portal and home blood pressure monitor |
Other: Kvatchii Portal
Online education portal
|
| No Intervention: Usual Care The control group will not have access to the portal but will be provided with home blood pressure monitor |
Outcome Measures
Primary Outcome Measures
- HBPM systolic blood pressure (SBP) area under the curve (AUC) [Baseline and 6 months]
HBPM systolic blood pressure (SBP) area under the curve (AUC)
Secondary Outcome Measures
- HBPM diastolic blood pressure (DBP) under the curve (AUC) [Baseline and 6 months]
HBPM diastolic blood pressure (DBP) under the curve (AUC)
- HBPM systolic blood pressure (SBP) under the curve (AUC) [Baseline and 12 months]
HBPM systolic blood pressure (SBP) under the curve (AUC)
- HBPM diastolic blood pressure (DBP) under the curve (AUC) [Baseline and 12 months]
HBPM diastolic blood pressure (DBP) under the curve (AUC)
- Change in knowledge of hypertension measured by Blood Pressure Knowledge questionnaire [Baseline, 6 months and 12 months]
True/false questions, 20 items, score 0-20 with higher indicating greater knowledge
- Change in health literacy measured by BRIEF: Health literacy Screening Tool [Baseline, 6 months and 12 months]
4 items, score 0-20 with higher score indicating greater health literacy
- Change in quality of life measured by EQ-5D-5L questionnaire [Baseline, 6 months and 12 months]
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.
- Change in quality of life measured by Patient Health Questionnaire (PHQ-9) questionnaire [Baseline, 6 months and 12 months]
9 items, score 0-27 with higher score indicating greater severity of depression
- Change in quality of life measured by the generalised anxiety disorder 7 item scale (GAD-7) [Baseline, 6 months and 12 months]
7 items, score 0-21 with higher score indicating greater anxiety
- Change in antihypertensive medicine adherence measured by the Hill-Bone compliance to High Blood Pressure Therapy Scale (HB-HBP) [Baseline, 6 months and 12 months]
14 items, score 0-56 with higher score indicating higher compliance
- Change in lifestyle measured by lifestyle questionnaire [Baseline, 6 months and 12 months]
13 items, lower score indicating poorer lifestyle
- Antihypertensive medication changes [Baseline, 6 months and 12 months]
Number of antihypertensive medication changes measured by number of medicines altered from last visit
- Evaluation of the Kvatchii portal measured by system usability scale (SUS) [over the course of 24 months]
10 items, score 0-100 with higher score indicating better usability
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Glasgow Clinical Research Facility | Glasgow | Scotland | United Kingdom | G51 4TF |
Sponsors and Collaborators
- NHS Greater Glasgow and Clyde
Investigators
- Principal Investigator: Linsay McCallum, MBChB PhD, NHS Greater Glasgow and Clyde
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INGN21CA393