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

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Kvatchii Portal
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring Hypertension, Home Blood Pressure Monitoring, Digital health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Glasgow Clinical Research FacilityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Kvatchii Portal

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HBPM diastolic blood pressure (DBP) under the curve (AUC)
HBPM diastolic blood pressure (DBP) under the curve (AUC)
HBPM systolic blood pressure (SBP) under the curve (AUC)
HBPM systolic blood pressure (SBP) under the curve (AUC)
HBPM diastolic blood pressure (DBP) under the curve (AUC)
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Change in knowledge of hypertension measured by Blood Pressure Knowledge questionnaire
True/false questions, 20 items, score 0-20 with higher indicating greater knowledge
Change in health literacy measured by BRIEF: Health literacy Screening Tool
4 items, score 0-20 with higher score indicating greater health literacy
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.
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
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
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
Change in lifestyle measured by lifestyle questionnaire
13 items, lower score indicating poorer lifestyle
Antihypertensive medication changes
Number of antihypertensive medication changes measured by number of medicines altered from last visit
Evaluation of the Kvatchii portal measured by system usability scale (SUS)
10 items, score 0-100 with higher score indicating better usability

Full Information

First Posted
October 6, 2022
Last Updated
January 23, 2023
Sponsor
NHS Greater Glasgow and Clyde
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1. Study Identification

Unique Protocol Identification Number
NCT05575453
Brief Title
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
Acronym
OPTIMA-BP
Official Title
OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
October 9, 2024 (Anticipated)
Study Completion Date
October 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Home Blood Pressure Monitoring, Digital health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kvatchii Portal
Arm Type
Active Comparator
Arm Description
The intervention group will be given access to the Kvatchii portal and home blood pressure monitor
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
The control group will not have access to the portal but will be provided with home blood pressure monitor
Intervention Type
Other
Intervention Name(s)
Kvatchii Portal
Intervention Description
Online education portal
Primary Outcome Measure Information:
Title
HBPM systolic blood pressure (SBP) area under the curve (AUC)
Description
HBPM systolic blood pressure (SBP) area under the curve (AUC)
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Description
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Time Frame
Baseline and 6 months
Title
HBPM systolic blood pressure (SBP) under the curve (AUC)
Description
HBPM systolic blood pressure (SBP) under the curve (AUC)
Time Frame
Baseline and 12 months
Title
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Description
HBPM diastolic blood pressure (DBP) under the curve (AUC)
Time Frame
Baseline and 12 months
Title
Change in knowledge of hypertension measured by Blood Pressure Knowledge questionnaire
Description
True/false questions, 20 items, score 0-20 with higher indicating greater knowledge
Time Frame
Baseline, 6 months and 12 months
Title
Change in health literacy measured by BRIEF: Health literacy Screening Tool
Description
4 items, score 0-20 with higher score indicating greater health literacy
Time Frame
Baseline, 6 months and 12 months
Title
Change in quality of life measured by EQ-5D-5L questionnaire
Description
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
Title
Change in quality of life measured by Patient Health Questionnaire (PHQ-9) questionnaire
Description
9 items, score 0-27 with higher score indicating greater severity of depression
Time Frame
Baseline, 6 months and 12 months
Title
Change in quality of life measured by the generalised anxiety disorder 7 item scale (GAD-7)
Description
7 items, score 0-21 with higher score indicating greater anxiety
Time Frame
Baseline, 6 months and 12 months
Title
Change in antihypertensive medicine adherence measured by the Hill-Bone compliance to High Blood Pressure Therapy Scale (HB-HBP)
Description
14 items, score 0-56 with higher score indicating higher compliance
Time Frame
Baseline, 6 months and 12 months
Title
Change in lifestyle measured by lifestyle questionnaire
Description
13 items, lower score indicating poorer lifestyle
Time Frame
Baseline, 6 months and 12 months
Title
Antihypertensive medication changes
Description
Number of antihypertensive medication changes measured by number of medicines altered from last visit
Time Frame
Baseline, 6 months and 12 months
Title
Evaluation of the Kvatchii portal measured by system usability scale (SUS)
Description
10 items, score 0-100 with higher score indicating better usability
Time Frame
over the course of 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linsay McCallum, MBChB PhD
Phone
01412327600
Email
Linsay.McCallum@ggc.scot.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linsay McCallum, MBChB PhD
Organizational Affiliation
NHS Greater Glasgow and Clyde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glasgow Clinical Research Facility
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ammani Brown, BA (Hons) MSc
Phone
0141 232 7600
Email
glasgow.crf@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Sandosh Padmanabhan, MBBS PhD
First Name & Middle Initial & Last Name & Degree
Stefanie Lip, BSc MBChB
First Name & Middle Initial & Last Name & Degree
Maggie Rostron, BSc MBChB
First Name & Middle Initial & Last Name & Degree
David Lowe, MBChB MD

12. IPD Sharing Statement

Plan to Share IPD
No

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OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure

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