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

ISRCTN ISRCTN72614272
DOI https://doi.org/10.1186/ISRCTN72614272
Protocol serial number N/A
Sponsor Napier University (UK)
Funder The BUPA Foundation (UK)
Submission date
21/10/2008
Registration date
11/12/2008
Last edited
14/02/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Janet Hanley
Scientific

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

Study information

Primary study designInterventional
Study designRandomised single-centre trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleSharing responsibility: The public health impact of a nurse-led telemetric home blood pressure monitoring service - randomised controlled trial
Study acronymHITS (Health Impact of nurse-led Telemetry Services): Hypertension
Study objectives1. 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(s)Lothian Research Ethics Committee 1, Lothian NHS Board, approved on 03/10/2008 (ref: LREC 08/S1101/38).
Health condition(s) or problem(s) studiedHypertension
InterventionThis 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date03/11/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration400
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment03/11/2008
Date of final enrolment03/11/2009

Locations

Countries of recruitment

  • United Kingdom
  • Scotland

Study participating centre

Centre for Integrated Healthcare
Edinburgh
EH4 2LD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 24/05/2013 Yes No
Results article further results 28/05/2013 Yes No
Results article results 31/01/2018 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

14/02/2018: Publication reference added.

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