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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Centre for Integrated Healthcare
Napier University
Comely Bank Campus
13 Crewe Road South
Edinburgh
EH4 2LD
United Kingdom
Study information
| Study design | Randomised single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Sharing responsibility: The public health impact of a nurse-led telemetric home blood pressure monitoring service - randomised controlled trial |
| Study acronym | HITS (Health Impact of nurse-led Telemetry Services): Hypertension |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure | 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 study start date | 03/11/2008 |
| Completion date | 03/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/11/2008 |
| Date of final enrolment | 03/11/2009 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Centre for Integrated Healthcare
Edinburgh
EH4 2LD
United Kingdom
EH4 2LD
United Kingdom
Sponsor information
Napier University (UK)
University/education
University/education
Research Office
Room G22
Merchiston Campus
Colinton Road
Edinburgh
EH10 5DT
Scotland
United Kingdom
| Website | http://www.napier.ac.uk |
|---|---|
"ROR" |
https://ror.org/03zjvnn91 |
Funders
Funder type
Charity
The BUPA Foundation (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
Editorial Notes
14/02/2018: Publication reference added.
