OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure (OPTIMA-BP)

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Kvatchii Portal

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linsay McCallum, MBChB PhD; Phone Number: 01412327600; Email: Linsay.McCallum@ggc.scot.nhs.uk

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G51 4TF
      • Recruiting
      • Glasgow Clinical Research Facility
      • Contact: Ammani Brown, BA (Hons) MSc; Phone Number: 0141 232 7600; Email: glasgow.crf@ggc.scot.nhs.uk
      • Sub-Investigator: Sandosh Padmanabhan, MBBS PhD
      • Sub-Investigator: Stefanie Lip, BSc MBChB
      • Sub-Investigator: Maggie Rostron, BSc MBChB
      • Sub-Investigator: David Lowe, MBChB MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Investigators: Principal Investigator: Linsay McCallum, MBChB PhD, NHS Greater Glasgow and Clyde

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2022
• Primary Completion (Anticipated): October 9, 2024
• Study Completion (Anticipated): October 9, 2024

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Home Blood Pressure Monitoring; Digital health
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: INGN21CA393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No