OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

Hypertension Clinical Trial

— OPTIMA-BP  

Official title:

OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05575453
• Other study ID #: INGN21CA393
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2022
• Est. completion date: October 9, 2024

Study information

• Verified date: January 2023
• Source: NHS Greater Glasgow and Clyde
• Contact: Linsay McCallum, MBChB PhD
• Phone: 01412327600
• Email: Linsay.McCallum[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 9, 2024
• Est. primary completion date: October 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Kvatchii Portal
Online education portal

Locations

Country	Name	City	State
United Kingdom	Glasgow Clinical Research Facility	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HBPM diastolic blood pressure (DBP) under the curve (AUC)	HBPM diastolic blood pressure (DBP) under the curve (AUC)	Baseline and 6 months
Secondary	HBPM systolic blood pressure (SBP) under the curve (AUC)	HBPM systolic blood pressure (SBP) under the curve (AUC)	Baseline and 12 months
Secondary	HBPM diastolic blood pressure (DBP) under the curve (AUC)	HBPM diastolic blood pressure (DBP) under the curve (AUC)	Baseline and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in lifestyle measured by lifestyle questionnaire	13 items, lower score indicating poorer lifestyle	Baseline, 6 months and 12 months
Secondary	Antihypertensive medication changes	Number of antihypertensive medication changes measured by number of medicines altered from last visit	Baseline, 6 months and 12 months
Secondary	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