HypertensionOPTIMA-BPNCT05575453
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
A study testing Kvatchii Portal in people with Hypertension, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Kvatchii Portal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2022to 9 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- Current attendance at the GBPC
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Glasgow Clinical Research Facility
Glasgow, Scotland, G51 4TF
Ammani Brown, BA (Hons) MSc, 0141 232 7600, glasgow.crf@ggc.scot.nhs.uk
Sandosh Padmanabhan, MBBS PhD
About this study
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.
- Conditions
- Hypertension
- Being tested
- Kvatchii Portal
- Keywords
- Hypertension, Home Blood Pressure Monitoring, Digital health
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kvatchii PortalOther
Online education portal
| Study group | Role | What they receive |
|---|---|---|
| Kvatchii Portal | Active comparator | The intervention group will be given access to the Kvatchii portal and home blood pressure monitor Receives: Other: Kvatchii Portal |
| Usual Care | No intervention | The control group will not have access to the portal but will be provided with home blood pressure monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBPM systolic blood pressure (SBP) area under the curve (AUC)
HBPM systolic blood pressure (SBP) area under the curve (AUC)
Measured: Baseline and 6 months
Secondary outcomes (12)
HBPM diastolic blood pressure (DBP) under the curve (AUC)
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Measured: Baseline and 6 months
HBPM systolic blood pressure (SBP) under the curve (AUC)
HBPM systolic blood pressure (SBP) under the curve (AUC)
Measured: Baseline and 12 months
HBPM diastolic blood pressure (DBP) under the curve (AUC)
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 6 months and 12 months
Change in lifestyle measured by lifestyle questionnaire
13 items, lower score indicating poorer lifestyle
Measured: Baseline, 6 months and 12 months
Antihypertensive medication changes
Number of antihypertensive medication changes measured by number of medicines altered from last visit
Measured: 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
Measured: over the course of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start29 Sep 2022
- Primary completion9 Oct 2024 (estimated)
- Study completion9 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linsay McCallum, MBChB PhD, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575453
- Sponsor's protocol ID
- INGN21CA393
- Acronym
- OPTIMA-BP
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38429056
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
- ClinicalTrials.gov ID
- NCT05575453
- Acronym / sponsor ID
- OPTIMA-BP / INGN21CA393
- Conditions
- Hypertension
- Keywords
- Hypertension, Home Blood Pressure Monitoring, Digital health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 9 Oct 2024 (estimated)
- Study completion
- 9 Oct 2024 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kvatchii Portal | Active comparator | Other: Kvatchii PortalThe intervention group will be given access to the Kvatchii portal and home blood pressure monitor |
| Usual Care | No intervention | –The control group will not have access to the portal but will be provided with home blood pressure monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18
- Current attendance at the GBPC
Key exclusion criteria (12 listed)
- Inability to give informed consent
- Non-English speakers
- No internet access
- Clinic or ambulatory blood pressure ≥180/120 mmHg
- Arm circumference >42cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kvatchii PortalOnline education portal | Other | Kvatchii Portal |
Primary outcome
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)
12 secondary outcomes
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Time frame: Baseline and 6 months
HBPM systolic blood pressure (SBP) under the curve (AUC)
Time frame: Baseline and 12 months
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Time frame: Baseline and 12 months
Change in knowledge of hypertension measured by Blood Pressure Knowledge questionnaire
Time frame: 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
Change in quality of life measured by EQ-5D-5L questionnaire
Time frame: 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
Change in quality of life measured by the generalised anxiety disorder 7 item scale (GAD-7)
Time frame: 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
Change in lifestyle measured by lifestyle questionnaire
Time frame: Baseline, 6 months and 12 months
Antihypertensive medication changes
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 38429056McCallum 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linsay McCallum, MBChB PhD principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kvatchii Portal in people with Hypertension, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linsay McCallum, MBChB PhD (01412327600, Linsay.McCallum@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBPM systolic blood pressure (SBP) area under the curve (AUC) (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05575453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.