Condition category
Urological and Genital Diseases
Date applied
23/08/2017
Date assigned
11/12/2017
Last edited
11/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Haynes

ORCID ID

Contact details

MRC Population Health Research Unit
Nuffield Department of Population Health
Richard Doll Building
Old Road Campus
Headington
Oxford
OX3 7LF
United Kingdom
+44 (0)186 574 3743
richard.haynes@ndph.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OXHARP1

Study information

Scientific title

Telemonitoring of blood pressure in chronic kidney disease: a feasibility study (Oxford Heart and Renal Protection Study-I)

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

Oxford C Research Ethics Committee, 15/06/2016, ref: 16/SC/0274

Study design

Non-randomized observational feasibility study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Home

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

30/01/2016

Overall trial end date

31/08/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

25

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

United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
OX3 7LE

Sponsor information

Organisation

University of Oxford

Sponsor details

Wellington Square
Oxford
OX1 2JD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Heart Foundation

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

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 statement
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).

Intention to publish date

31/08/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes