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OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05575453
Acronym
OPTIMA-BP
Enrollment
200
Registered
2022-10-12
Start date
2022-09-29
Completion date
2024-10-09
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Home Blood Pressure Monitoring, Digital health

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.

Interventions

OTHERKvatchii Portal

Online education portal

Sponsors

NHS Greater Glasgow and Clyde
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HBPM systolic blood pressure (SBP) area under the curve (AUC)Baseline and 6 monthsHBPM systolic blood pressure (SBP) area under the curve (AUC)

Secondary

MeasureTime frameDescription
HBPM systolic blood pressure (SBP) under the curve (AUC)Baseline and 12 monthsHBPM systolic blood pressure (SBP) under the curve (AUC)
Change in knowledge of hypertension measured by Blood Pressure Knowledge questionnaireBaseline, 6 months and 12 monthsTrue/false questions, 20 items, score 0-20 with higher indicating greater knowledge
Change in health literacy measured by BRIEF: Health literacy Screening ToolBaseline, 6 months and 12 months4 items, score 0-20 with higher score indicating greater health literacy
Change in quality of life measured by EQ-5D-5L questionnaireBaseline, 6 months and 12 months25 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) questionnaireBaseline, 6 months and 12 months9 items, score 0-27 with higher score indicating greater severity of depression
HBPM diastolic blood pressure (DBP) under the curve (AUC)Baseline and 6 monthsHBPM diastolic blood pressure (DBP) under the curve (AUC)
Change in antihypertensive medicine adherence measured by the Hill-Bone compliance to High Blood Pressure Therapy Scale (HB-HBP)Baseline, 6 months and 12 months14 items, score 0-56 with higher score indicating higher compliance
Change in lifestyle measured by lifestyle questionnaireBaseline, 6 months and 12 months13 items, lower score indicating poorer lifestyle
Antihypertensive medication changesBaseline, 6 months and 12 monthsNumber 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 months10 items, score 0-100 with higher score indicating better usability
Change in quality of life measured by the generalised anxiety disorder 7 item scale (GAD-7)Baseline, 6 months and 12 months7 items, score 0-21 with higher score indicating greater anxiety

Countries

United Kingdom

Contacts

Primary ContactLinsay McCallum, MBChB PhD
Linsay.McCallum@ggc.scot.nhs.uk01412327600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026