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
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
-
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.
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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.