OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

NCT05575453 | Unknown

• 1 other identifier: INGN21CA393
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Hypertension; Home Blood Pressure Monitoring; Digital health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• HBPM diastolic blood pressure (DBP) under the curve (AUC)

  Baseline and 6 months

• HBPM systolic blood pressure (SBP) under the curve (AUC)

  Baseline and 12 months

• HBPM diastolic blood pressure (DBP) under the curve (AUC)

  Baseline and 12 months

• Change in knowledge of hypertension measured by Blood Pressure Knowledge questionnaire

  Baseline, 6 months and 12 months

• Change in health literacy measured by BRIEF: Health literacy Screening Tool

  Baseline, 6 months and 12 months

Study Arms (2)

Kvatchii Portal

ACTIVE COMPARATOR

The intervention group will be given access to the Kvatchii portal and home blood pressure monitor

Other: Kvatchii Portal

Usual Care

NO INTERVENTION

The control group will not have access to the portal but will be provided with home blood pressure monitor

Interventions

Kvatchii Portal OTHER

Online education portal

Kvatchii Portal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Current attendance at the GBPC

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Glasgow Clinical Research Facility

Glasgow, Scotland, G51 4TF, United Kingdom

RECRUITING

Related Publications (1)

• McCallum L, Lip S, Rostron M, Hanna R, Bin Pg Md Salimin N, Nichol S, Padmanabhan S. OPTIMA-BP: empOwering PaTients in MAnaging Blood Pressure - protocol for a randomised parallel group study comparing use of Kvatchii web-based patient education portal as an addition to home blood pressure monitoring. Open Heart. 2024 Mar 1;11(1):e002535. doi: 10.1136/openhrt-2023-002535.

  PMID: 38429056 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Linsay McCallum, MBChB PhD

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linsay McCallum, MBChB PhD

CONTACT

01412327600; Linsay.McCallum@ggc.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 12, 2022
• Study Start: September 29, 2022
• Primary Completion: October 9, 2024
• Study Completion: October 9, 2024
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)