OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

NCT ID: NCT05575453

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-29

Study Completion Date

2024-10-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Kvatchii Portal

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

Group Type ACTIVE_COMPARATOR

Kvatchii Portal

Intervention Type OTHER

Online education portal

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Kvatchii Portal

Online education portal

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Linsay McCallum, MBChB PhD

Role: PRINCIPAL_INVESTIGATOR

NHS Greater Glasgow and Clyde

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Glasgow Clinical Research Facility

Glasgow, Scotland, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Linsay McCallum, MBChB PhD

Role: CONTACT

01412327600

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ammani Brown, BA (Hons) MSc

Role: primary

0141 232 7600

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38429056 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

INGN21CA393

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Optimised Treatment for Hypertension Trial
NCT06935760 NOT_YET_RECRUITING NA