Telemonitoring of blood pressure in chronic kidney disease
| ISRCTN | ISRCTN13725286 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13725286 |
| Secondary identifying numbers | OXHARP1 |
- Submission date
- 23/08/2017
- Registration date
- 11/12/2017
- Last edited
- 12/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Blood pressure (BP) is believed to be an important risk factor among patients with chronic kidney disease (CKD). BP is associated with both risk of cardiovascular (heart) complications and progression of CKD. Studies of different BP targets are required to inform the treatment of the large number of people with CKD. BP is traditionally measured during hospital or general practice visits, but such visits are costly and possibly not representative of a patient's usual BP. Telemonitoring technology (where a patient measures their BP at home with a machine that automatically sends the results to a central computer where they can be reviewed by trained clinical staff) may help reduce the costs of accurately measuring BP, but its feasibility among people with CKD is uncertain. The aim of this study is to assess the acceptability of telemonitoring BP over 3 months.
Who can participate?
Patients aged 18 or over with chronic kidney disease
What does the study involve?
Participants are provided with a blood pressure machine and tablet device and trained how to use them. They are requested to measure their BP daily for the first month and then on alternate days for the next two months (so the total duration is 3 months). The blood pressure data is automatically sent from the BP machine to the tablet from where it is securely uploaded to the study database where it can be viewed by the research team. The acceptability and utility of telemonitoring are assessed.
What are the possible benefits and risks of participating?
The main burden of this study is the frequency of BP measurement (at least daily for 1 month and then alternate days for 2 months). However, the requirement for this would be explained clearly before starting and determining the acceptability of this is the main aim of this study. During months 2 and 3, participants’ BP-lowering treatment may be changed. Such changes in treatment may be accompanied by side effects but these are rarely serious. Participants are advised of what to do should they become intrusive and they are encouraged to contact the research team if they wish to discuss them.
Where is the study run from?
Oxford University Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2016 to August 2017
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
Dr Richard Haynes
richard.haynes@ndph.ox.ac.uk
Contact information
Scientific
MRC Population Health Research Unit, Nuffield Department of Population Health, Richard Doll Building, Old Road Campus, Headington
Oxford
OX3 7LF
United Kingdom
| Phone | +44 (0)186 574 3743 |
|---|---|
| richard.haynes@ndph.ox.ac.uk |
Study information
| Study design | Non-randomized observational feasibility study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Home |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Telemonitoring of blood pressure in chronic kidney disease: a feasibility study (Oxford Heart and Renal Protection Study-I) |
| Study acronym | OX HARP-I |
| Study hypothesis | The primary aim is to assess the participants’ acceptability of telemonitoring BP over 3 months, assessed by the proportion of patients who provide at least 90% of the expected readings. |
| Ethics approval(s) | Oxford C Research Ethics Committee, 15/06/2016, ref: 16/SC/0274 |
| Condition | Chronic kidney disease |
| Intervention | Willing and eligible patients will be provided with a blood pressure machine and tablet device and trained how to use them. They will be requested to measure their BP daily for the first month and then on alternate days for the next two months (so the total duration is 3 months). The blood pressure data is automatically sent from the BP machine to the tablet from where it is securely uploaded to the study database where it can be viewed by the research team. The acceptability of such methodology and its utility in clinical practice and future research are assessed. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Proportion of participants who provide >90% of expected data points, assessed at 3 months |
| Secondary outcome measures | 1. Intra-individual variation in home BP, assessed at 1 and 3 months 2. Proportion of patients reaching target BP, assessed at 3 months |
| Overall study start date | 30/01/2016 |
| Overall study end date | 31/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 |
| Total final enrolment | 25 |
| Participant inclusion criteria | Men or women aged >=18 years at screening with either: 1. Estimated glomerular filtration rate (eGFR) >=20 <45 mL/min/1.73m2; OR 2. eGFR >=45 <60 mL/min/1.73m2 and urine albumin:creatinine ratio >20 mg/mmol (or protein:creatinine ratio >30 mg/mmol) |
| Participant exclusion criteria | 1. Mean systolic BP <130 mmHg at screening visit 2. Planned change to BP lowering therapy during intensive monitoring phase 3. Acute vascular event (e.g. acute coronary syndrome, transient ischaemic attack or stroke) within last month 4. Medical history that might limit the patient’s ability to comply with study procedures for the duration of the study |
| Recruitment start date | 01/11/2016 |
| Recruitment end date | 15/04/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
OX3 7LE
United Kingdom
Sponsor information
University/education
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The trialists plan to publish in a peer-reviewed medical journal within one year of the end of the study. The protocol will be available at the time of publication. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the chief investigator Dr Richard Haynes (richard.haynes@ndph.ox.ac.uk) according to the departmental data access policy (https://www.ndph.ox.ac.uk/about/data-access-policy). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 13/09/2018 | 13/09/2018 | No | No | |
| Results article | results | 21/12/2018 | 12/06/2019 | Yes | No |
| Protocol file | version 2.0 | 23/11/2016 | 12/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN13725286_BasicResults_13Sep18.pdf
- Uploaded 13/09/2018
- 34075 OX HARP1 Protocol_V2.0_23Nov2016.pdf
Editorial Notes
12/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
12/06/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
13/09/2018: The basic results of this trial have been uploaded as an additional file. The intention to publish date was updated from 31/08/2018 to 31/12/2018.
