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Sharing responsibility: The public health impact of a nurse-led telemetric home blood pressure monitoring service
ISRCTN ISRCTN72614272
DOI 10.1186/ISRCTN72614272
ClinicalTrials.gov identifier
EudraCT number
Public title Sharing responsibility: The public health impact of a nurse-led telemetric home blood pressure monitoring service
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
Serial number at source N/A
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?
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Hypertension
Participants - 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
Participants - 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
Anticipated start date 03/11/2008
Anticipated end date 03/11/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 400
Interventions 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.
Primary outcome measure(s) Average daytime systolic blood pressure at 6 months measured by ambulatory monitoring.
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
Sources of funding The BUPA Foundation (UK)
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23709583
2013 further results in http://www.ncbi.nlm.nih.gov/pubmed/23793649
Contact name Dr  Janet  Hanley
  Address Centre for Integrated Healthcare
Napier University
Comely Bank Campus
13 Crewe Road South
  City/town Edinburgh
  Zip/Postcode EH4 2LD
  Country United Kingdom
Sponsor Napier University (UK)
  Address Research Office
Room G22
Merchiston Campus
Colinton Road
  City/town Edinburgh
  Zip/Postcode EH10 5DT
  Country United Kingdom
  Sponsor website: http://www.napier.ac.uk
Date applied 21/10/2008
Last edited 17/07/2013
Date ISRCTN assigned 11/12/2008
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