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Status unknownNCT05575453OPTIMA-BPUpdated Jan 25, 2023

OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

An interventional study of Kvatchii Portal in Hypertension, sponsored by NHS Greater Glasgow and Clyde. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-25.

Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • Home Blood Pressure Monitoring
  • Digital health
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's planned enrollment of 200 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

NHS Greater Glasgow and Clyde is the lead sponsor of 220 studies on the registry; 39 are open to participants now.

Browse NHS Greater Glasgow and Clyde studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18
  • Current attendance at the GBPC

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Kvatchii Portal

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

    Other: Kvatchii Portal

  • No intervention
    Usual Care

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

Interventions

  • OtherKvatchii Portal

    Online education portal

06

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline and 6 months

Secondary outcomes

  1. HBPM diastolic blood pressure (DBP) under the curve (AUC)

    HBPM diastolic blood pressure (DBP) under the curve (AUC)

    Time frame: Baseline and 6 months

  2. HBPM systolic blood pressure (SBP) under the curve (AUC)

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

    Time frame: Baseline and 12 months

  3. HBPM diastolic blood pressure (DBP) under the curve (AUC)

    HBPM diastolic blood pressure (DBP) under the curve (AUC)

    Time frame: Baseline and 12 months

  4. Change in knowledge of hypertension measured by Blood Pressure Knowledge questionnaire

    True/false questions, 20 items, score 0-20 with higher indicating greater knowledge

    Time frame: Baseline, 6 months and 12 months

  5. Change in health literacy measured by BRIEF: Health literacy Screening Tool

    4 items, score 0-20 with higher score indicating greater health literacy

    Time frame: Baseline, 6 months and 12 months

  6. 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.

    Time frame: Baseline, 6 months and 12 months

  7. 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

    Time frame: Baseline, 6 months and 12 months

  8. 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

    Time frame: Baseline, 6 months and 12 months

  9. 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

    Time frame: Baseline, 6 months and 12 months

  10. Change in lifestyle measured by lifestyle questionnaire

    13 items, lower score indicating poorer lifestyle

    Time frame: Baseline, 6 months and 12 months

  11. Antihypertensive medication changes

    Number of antihypertensive medication changes measured by number of medicines altered from last visit

    Time frame: Baseline, 6 months and 12 months

  12. Evaluation of the Kvatchii portal measured by system usability scale (SUS)

    10 items, score 0-100 with higher score indicating better usability

    Time frame: over the course of 24 months

07

Study locations

1 of 1 sites recruiting
  • Glasgow Clinical Research Facility
    Glasgow, Scotland G51 4TF, United Kingdom
    • Ammani Brown, BA (Hons) MSc · Contact · glasgow.crf@ggc.scot.nhs.uk · 0141 232 7600
    • Sandosh Padmanabhan, MBBS PhD · Sub investigator
    • Stefanie Lip, BSc MBChB · Sub investigator
    • Maggie Rostron, BSc MBChB · Sub investigator
    • David Lowe, MBChB MD · Sub investigator
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2022 (actual). Primary completion is estimated for Oct 2024, 24 months after the start.

Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 24 months is close to that.

Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2022
First posted
Oct 12, 2022
StartActual
Sep 29, 2022
Primary completionEst.
Oct 9, 2024
CompletionEst.
Oct 9, 2024
Last update
Jan 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05575453
Lead sponsor
NHS Greater Glasgow and Clyde
Responsible party
Sponsor
First posted
Oct 12, 2022
Start date
Sep 29, 2022
Primary completion
Oct 9, 2024 (estimated)
Completion
Oct 9, 2024 (estimated)
Last update
Jan 25, 2023

Study contacts

Linsay McCallum, MBChB PhD
Contact
Linsay.McCallum@ggc.scot.nhs.uk
01412327600
Linsay McCallum, MBChB PhD
principal investigator · NHS Greater Glasgow and Clyde

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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