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

January 23, 2023 updated by: NHS Greater Glasgow and Clyde
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • Recruiting
        • Glasgow Clinical Research Facility
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Time Frame: Baseline and 6 months
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Baseline and 6 months
HBPM systolic blood pressure (SBP) under the curve (AUC)
Time Frame: Baseline and 12 months
HBPM systolic blood pressure (SBP) under the curve (AUC)
Baseline and 12 months
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Time Frame: 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
Time Frame: Baseline, 6 months and 12 months
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
Time Frame: Baseline, 6 months and 12 months
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
Time Frame: Baseline, 6 months and 12 months
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
Time Frame: Baseline, 6 months and 12 months
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)
Time Frame: Baseline, 6 months and 12 months
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)
Time Frame: Baseline, 6 months and 12 months
14 items, score 0-56 with higher score indicating higher compliance
Baseline, 6 months and 12 months
Change in lifestyle measured by lifestyle questionnaire
Time Frame: Baseline, 6 months and 12 months
13 items, lower score indicating poorer lifestyle
Baseline, 6 months and 12 months
Antihypertensive medication changes
Time Frame: Baseline, 6 months and 12 months
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)
Time Frame: over the course of 24 months
10 items, score 0-100 with higher score indicating better usability
over the course of 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NHS Greater Glasgow and Clyde

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Linsay McCallum, MBChB PhD, NHS Greater Glasgow and Clyde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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