A trial of the Home & Online Management & Evaluation of Blood Pressure (HOME BP) digital intervention for self-management of uncontrolled, essential hypertension in primary care
| ISRCTN | ISRCTN13790648 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13790648 |
| Secondary identifying numbers | 18553 |
- Submission date
- 14/05/2015
- Registration date
- 14/05/2015
- Last edited
- 16/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
High blood pressure (BP), or hypertension, occurs when a person’s blood pressure is continually higher than recommended. It is often referred to as a “silent killer” as, although it rarely results in symptoms of its own, if left untreated it can increase the likelihood of the affected person having a heart attack or a stroke. Treatment involves lifestyle changes for the patient and possibly prescribed medication. The HOME BP intervention is designed to help people self-manage their raised BP through self-monitoring, medication adherence and lifestyle changes using the HOME BP online system with optional nurse support. We want to compare people using HOME BP intervention to those receiving usual GP care for their hypertension. The trial aims to test whether BP is reduced in patients with existing uncontrolled hypertension (>140/90) when patients and clinicians use HOME BP online to adopt gold standard procedures for home monitoring and adjusting medication.
Who can participate?
Adults (aged at least 18) with above target blood pressure (>140/90), who are currently taking medication to control their blood pressure.
What does the study involve?
Patients are randomly allocated into one of two groups. Those in group 1 (control) receive their usual standard of care. Those in group 2 (intervention) are given access to HOME BP. All patients (from both groups) are given a blood pressure medication review with a GP at the start of the study. Using HOME BP online, patients in group 2 are trained to monitor their blood pressure, and reminded to take their own readings for one week each month. These readings are entered in to HOME BP online, which lets patients and their GPs know when blood pressure has remained too high for too long. Any changes in medication, such as extra or different medications, are based on the home readings and confirmed by the GP. A nurse is available to help patients use the online programme, the blood pressure monitor or offer support with making healthy lifestyle changes to reduce blood pressure. Patients monitor and record their own blood pressure for 12 months. It is also measured by a research nurse at 6 months and 12 months after joining the study. The main outcome (that is the main thing the trial will measure) is blood pressure and this is compared between HOME BP and usual care groups after 12 months. Other important trial measurements include blood pressure differences at six months, any changes in blood pressure medication, quality of life and patient beliefs about hypertension self-management. Some patients in the HOME BP group will be invited to discuss their experiences of the study.
What are the possible benefits and risks of participating?
Taking part in the study may have a positive impact upon a participant’s health. Previous studies have found improvements in blood pressure for people who self-monitor and self-manage their blood pressure. We think there is very little risk of harm in taking part. Their practice nurse will be in contact with each participant throughout the study, and will be able to advise if any participant experiences any problems.
Where is the study run from?
Southampton Primary Medical Care (University of Southampton) and Radcliffe Infirmary ISAT Headquarters (Oxford)
When is the study starting and how long is it expected to run for?
January 2014 to December 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Kate Morton (public)
k.s.morton@soton.ac.uk
Contact information
Public
Centre for Clinical and Community Applications of Health Psychology
University of Southampton
Room 3063, Building 44
Highfield Campus
Southampton
SO17 1BJ
United Kingdom
 ORCID ID |
0000-0002-6674-0314 |
|---|---|
| Phone | +44 (0)2380 592234 |
| k.s.morton@soton.ac.uk |
Study information
| Study design | Randomised; Interventional and Observational; Design type: Process of Care, Treatment, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | The Home & Online Management & Evaluation of Blood Pressure (HOME BP) digital intervention for self-management of uncontrolled, essential hypertension: a randomised controlled trial |
| Study acronym | HOME-BP |
| Study hypothesis | Current hypothesis as of 19/05/2016: The aim of the HOME BP trial is to evaluate the addition of the HOME BP intervention with nurse support into primary care for the self-management of hypertension in comparison to usual care. The study also aims to address: 1. Does the HOME BP intervention to assist self-monitoring and self-management of uncontrolled hypertension result in greater control of systolic blood pressure after one year? 2. Does the HOME BP intervention result in greater control of systolic and diastolic blood pressure after six months and diastolic blood pressure after one year? 3. Is the HOME BP intervention more cost-effective than usual care in managing poorly controlled hypertension in primary care? 4. Which factors are related to patient engagement and adherence to HOME BP? 5. Which factors are related to patient medication adherence and uptake of recommended medication titrations? 6. Does the inclusion of lifestyle change choices and behavioural support result in engagement with lifestyle change? 7. Is the HOME BP intervention acceptable to patients when integrated into routine practice? 8. What are patient and health care practitioner views and experiences of the HOME BP intervention and its integration addition into primary care for the self-management of poorly controlled hypertension? Previous hypothesis: The aim of the study is to evaluate the use of the HOME BP programme to assist self-monitoring and self-management of uncontrolled hypertension compared to usual care. The study also aims to address: 1. Is the HOME-BP programme a cost-effective method for managing poorly controlled hypertension in primary care? 2. Is the HOME BP programme acceptable to patients and what are the factors affecting engagement and adherence to the HOME BP programme? 3. What are patient and health care practitioner views and experiences of the HOME-BP programme and its integration into primary care for the self-management of poorly controlled hypertension? |
| Ethics approval(s) | NRES Hampshire A, 19/03/2015, ref: 15/SC/0082. |
| Condition | Topic: Primary Care, Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics), Primary care; Disease: Cardiovascular, All Diseases |
| Intervention | Interventions as of 19/05/2016: 574 (updated to 610 22/01/18) participants will be randomised to usual care (UC) and the HOME BP intervention arm (1:1): 1. HOME BP: Patients will have access to HOME BP online. Patients will be asked to monitor their blood pressure for 7 days each month, taking two BP measurements, five minutes apart at the same time each day. Patients will record the second blood pressure reading and enter these into HOME BP online after 7 readings have been recorded. HOME BP online will calculate mean blood pressure, using an algorithm to recommend that adjustment of anti-hypertensive medication is required when blood pressure remains above target. Readings triggering the recommendation for medication adjustment will be sent to the healthcare professional by email, who will then issue a prescription or indicate that this is not required. Very high or low readings will follow an offline procedure where the patient contacts their surgery directly. 2. Usual Care: After a post-randomisation medication review participants will receive usual care for blood pressure management. Previous interventions: 574 participants will be randomised to usual care (UC) and the HOME BP intervention arm (1:1): 1. HOME BP: Patients will have access to the online HOME BP programme. Patients will be asked to monitor their blood pressure for 7 days each month. Patients will record the second blood pressure reading and enter these into the programme after 7 readings have been recorded. The HOME BP programme will calculate a mean blood pressure, using an algorithm to recommend adjustment of anti-hypertensive medication when blood pressure remains above target. Readings will be sent to the patient and healthcare professionals by email. High or low readings will follow an offline procedure where the patient contacts their surgery directly. 2. Usual Care: After a post-randomisation medication review participants will receive usual care for blood pressure management. |
| Intervention type | Behavioural |
| Primary outcome measure | Systolic BP (mean of 2nd and 3rd BP readings); Timepoint(s): 12 months |
| Secondary outcome measures | Current secondary outcome measures as of 19/05/2016: 1. Systolic and diastolic BP; Timepoint(s) 6 and 12 months 2. Prescribing data and consultations; Timepoint(s) 12 months 3. Patient medication use (number and defined daily doses); Timepoint(s) 6 and 12 months 4. Health-related quality of life; Timepoint(s) 6 and 12 months 5. Questionnaire measures on patient enablement Costs of equipment and drugs, Health professional and patient time; Timepoint(s) 12 months Process analysis measures: 1. Questionnaire measure of patient self-efficacy; Timepoint(s) 6 and 12 months 2. Patient medication beliefs, adherence and self-reported side effects; Timepoint(s) 6 and 12 months 3. Patient weight measured within clinic and self-reported lifestyle behaviours; Timepoint 12 months 4. Patient blood pressure (BP) monitoring adherence measured by the HOME BP online system; Timepoint ongoing 5. Utilisation of optional support provision; Timepoint ongoing 6. Digital intervention website usage and engagement, including lifestyle choice, usage and progress; Timepoint ongoing 7. Adherence to recommended medication changes; Timepoint ongoing 8. Prescriber and support provider self-efficacy and outcome expectations; Timepoint baseline 9. Prescriber and support provider confidence in the acceptability of the intervention; Timepoint baseline Previous secondary outcome measures: 1. Systolic and diastolic BP; Timepoint(s) 6 and 12 months 2. Prescribing data and consultations; Timepoint(s) 12 months 3. Patient medication beliefs, adherence, changes and self-reported side-effects; Timepoint(s) 6 and 12 months 4. Questionnaire measures on patient enablement and self-efficacy; Timepoint(s) 6 and 12 months 5. Health-related quality of life; Timepoint(s) 6 and 12 months 6. Costs of equipment and drugs, Health professional and patient time; Timepoint(s) 12 months |
| Overall study start date | 01/01/2014 |
| Overall study end date | 31/12/2018 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 610; UK Sample Size: 610 |
| Total final enrolment | 622 |
| Participant inclusion criteria | Patients: 1. Adult patients (at least 18) with uncontrolled hypertension (patients with a reading of >140/90 mmHg at baseline before randomisation), who are currently receiving medication for hypertension control 2. Patients must have access to the internet Healthcare Practitioners: 1. Employed in primary care setting 2. Involved in treating/managing patients with high blood pressure and enrolled on the HOME BP programme |
| Participant exclusion criteria | 1. Inability to self monitor (including diagnosis of dementia) 2. Mean baseline Bblood pressure >180/110 mmHg 3. Prescribed mMore than three antihypertensive medications 4. Hypertension not managed by family doctor 5. Terminal disease or other condition which in the opinion of the family doctor makes them inappropriate to take part 6. Patients with an acute cardiovascular event in the last 3 months 7. Postural hypotension (>20mmHg systolic drop after 1mn standing) 8. Pregnant or breast feeding 9. Patients with a history of proteinuria 10. Atrial fibrillation (or irregular heartbeat) 11. CKD stage 34-5 diagnosis or CKD stage 3 not managed by GP 12. Household member already enrolled on the study |
| Recruitment start date | 01/06/2015 |
| Recruitment end date | 31/12/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
OX2 6HE
United Kingdom
Sponsor information
Hospital/treatment centre
University Road
Southampton
SO17 1BJ
England
United Kingdom
"ROR" |
https://ror.org/01ryk1543 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Paul Little (P.Little@soton.ac.uk). Anonymised primary outcome data will be available from the date the main trial outcomes paper is published. Requests for the data will be assessed by the relevant team to ensure data sharing is appropriate. Participants did not provide explicit consent to the sharing of their data beyond the study team. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/11/2016 | Yes | No | |
| Other publications | nested qualitative process study | 08/05/2018 | 17/05/2019 | Yes | No |
| Results article | results | 19/01/2021 | 22/01/2021 | Yes | No |
| Results article | process evaluation results | 26/05/2021 | 28/05/2021 | Yes | No |
| Funder report results | NIHR | 31/12/2022 | 16/05/2023 | No | No |
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
16/05/2023: Publication reference added.
28/05/2021: Publication reference added.
22/01/2021: Publication reference added.
05/12/2019: The following changes have been made:
1.The final enrolment number has been added.
2. The intention to publish date has been changed from 30/07/2019 to 30/09/2020.
17/05/2019: Publication reference added.
14/06/2018: IPD sharing statement updated.
14/02/2018: The following changes were made:
1. Publication & dissemination plan, intention to publish date and participant level data were added.
2. Kate Morton replaced Jo Kelly as the primary study contact.
22/01/2018: The target number of participants was changed from 574 to 610.
10/11/2016: Publication reference added.
19/05/2016: The following changes were made to the trial record:
1. The number of participants has changed from 634 to 574.
2. The public title has been changed from "Development of a hypertension self-management digital intervention to be integrated and supported within primary care" to "A trial of the Home & Online Management & Evaluation of Blood Pressure (HOME BP) digital intervention for self-management of uncontrolled, essential hypertension in primary care".
3. The scientific title has been changed from "Development of a hypertension self-management digital intervention to be integrated and supported within primary care: pilot trial and randomised controlled trial. to "The Home & Online Management & Evaluation of Blood Pressure (HOME BP) digital intervention for self-management of uncontrolled, essential hypertension: a randomised controlled trial".
