Condition category
Circulatory System
Date applied
21/10/2008
Date assigned
11/12/2008
Last edited
17/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janet Hanley

ORCID ID

Contact details

Centre for Integrated Healthcare
Napier University
Comely Bank Campus
13 Crewe Road South
Edinburgh
EH4 2LD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Sharing responsibility: The public health impact of a nurse-led telemetric home blood pressure monitoring service - randomised controlled trial

Acronym

HITS (Health Impact of nurse-led Telemetry Services): Hypertension

Study hypothesis

1. To determine whether there is any reduction in average blood pressure and other specific cardiovascular risk factors in the group using the telemetric home blood pressure monitoring service compared to a control group receiving care as usual.
2. Is there any difference in adherence to lifestyle advice (smoking, diet, alcohol and salt intake, exercise) compared with a control group?
3. Is there any difference in the number and type of contacts with primary care amongst the group using telemetric home blood pressure monitoring compared with a control group?
4. What are people's experiences and opinions of this service including impact on behaviour, mood, positive and negative experiences and change in relationship with their health care provider?

Ethics approval

Lothian Research Ethics Committee 1, Lothian NHS Board, approved on 03/10/2008 (ref: LREC 08/S1101/38).

Study design

Randomised single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Hypertension

Intervention

This is a randomised, single-centre trial of a telemetric home blood pressure monitoring service. This trial is also a qualitative study of a different model of service involving interviews and focus groups.

Patients in the intervention group will be given blood pressure monitors (Stabil-O-Graph20) which use Bluetooth to transmit readings via a (supplied) mobile phone to a remote server. The user may securely access their record on the server at any time (either at home if they have internet access, or in a library or other public internet access point). Their GP and practice nurse will also be able to access this record via the internet. Users will also receive regular automated text or email feedback (or both if they wish) based on the reading they just sent and their rolling average blood pressure over the past 10 readings. The system can be set to provide reminders to check blood pressure and alerts to both the user (via the mobile phone) and the GP practice (via email) when the rolling average blood pressure remains high. If an individual user is unable to use text or email, it will be possible to arrange for feedback and alerts to be printed in the practice and posted to them or a voicemail system to be used. This will continue for 6 months. The baseline measurements will be repeated for both the intervention and control group at six months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Average daytime systolic blood pressure at 6 months measured by ambulatory monitoring.

Secondary outcome measures

The following will be assessed at baseline and 6 months:
1. Average diastolic blood pressure
2. Serum cholesterol
3. Body mass index
4. Breath carbon monoxide
5. Spot urinary sodium/creatinine ratio
6. HbA1c
7. Self-reported alcohol intake and smoking
8. Anxiety and depression, assessed by the Hospital Anxiety and Depression (HAD) scale
9. Quality of life (Euroqol)
10. Self-efficacy and medication adherence
11. Grip strength
12. Self-reported exercise frequency
13. Self-reported exercise tolerance
14. Number of attendances at practice nurse, GP, accident and emergency and out of hours care
15. Prescriptions for anti-hypertensives taken from GP practice records
16. Number of telephone/email contacts with practice nurses and GPs
17. Health care providers' experiences and opinions of this service

Overall trial start date

03/11/2008

Overall trial end date

03/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, aged over 18 years
2. On practices' hypertension registers
3. Last recorded surgery blood pressure over 150 mmHg systolic or 90 mmHg diastolic

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Secondary hypertension
2. Hypertension or renal disease being managed in secondary care
3. On practice stroke register
4. Treatment for cardiac event, or other life-threatening illness within the past 6 months or surgery within the last 3 months
5. Unable to consent
6. Unable to use self-monitoring equipment
7. Atrial fibrillation
8. Patients with diabetes will also be excluded from this trial because they have different blood pressure targets and excluding them will simplify the initial introduction of the home monitoring service for GPs and practice nurses
9. Pregnancy
10. Daytime ambulatory blood pressure <135/85 mmHg

Recruitment start date

03/11/2008

Recruitment end date

03/11/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Integrated Healthcare
Edinburgh
EH4 2LD
United Kingdom

Sponsor information

Organisation

Napier University (UK)

Sponsor details

Research Office
Room G22
Merchiston Campus
Colinton Road
Edinburgh
EH10 5DT
United Kingdom

Sponsor type

University/education

Website

http://www.napier.ac.uk

Funders

Funder type

Charity

Funder name

The BUPA Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23709583
2013 further results in http://www.ncbi.nlm.nih.gov/pubmed/23793649

Publication citations

  1. Results

    McKinstry B, Hanley J, Wild S, Pagliari C, Paterson M, Lewis S, Sheikh A, Krishan A, Stoddart A, Padfield P, Telemonitoring based service redesign for the management of uncontrolled hypertension: multicentre randomised controlled trial., BMJ, 2013, 346, f3030.

  2. Further results

    Hanley J, Ure J, Pagliari C, Sheikh A, McKinstry B, Experiences of patients and professionals participating in the HITS home blood pressure telemonitoring trial: a qualitative study., BMJ Open, 2013, 3, 5, doi: 10.1136/bmjopen-2013-002671.

Additional files

Editorial Notes