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Clinical Trials/NCT05575453
NCT05575453
Recruiting
Not Applicable

OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

NHS Greater Glasgow and Clyde1 site in 1 country200 target enrollmentSeptember 29, 2022
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
NHS Greater Glasgow and Clyde
Enrollment
200
Locations
1
Primary Endpoint
HBPM systolic blood pressure (SBP) area under the curve (AUC)
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 29, 2022
End Date
October 9, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: Baseline and 6 months

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

Secondary Outcomes

  • Change in quality of life measured by the generalised anxiety disorder 7 item scale (GAD-7)(Baseline, 6 months and 12 months)
  • Change in quality of life measured by EQ-5D-5L questionnaire(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)(Baseline, 6 months and 12 months)
  • Evaluation of the Kvatchii portal measured by system usability scale (SUS)(over the course of 24 months)
  • HBPM diastolic blood pressure (DBP) under the curve (AUC)(Baseline and 12 months)
  • Change in health literacy measured by BRIEF: Health literacy Screening Tool(Baseline, 6 months and 12 months)
  • Change in knowledge of hypertension measured by Blood Pressure Knowledge questionnaire(Baseline, 6 months and 12 months)
  • HBPM systolic blood pressure (SBP) under the curve (AUC)(Baseline and 12 months)
  • Change in quality of life measured by Patient Health Questionnaire (PHQ-9) questionnaire(Baseline, 6 months and 12 months)
  • Change in lifestyle measured by lifestyle questionnaire(Baseline, 6 months and 12 months)
  • Antihypertensive medication changes(Baseline, 6 months and 12 months)

Study Sites (1)

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