To assess the one-year (cost)effectiveness of telemonitoring of blood pressure and self-management support via an internet-based service in addition to usual care as compared to usual care alone in a pragmatic trial in patients with uncontrolled…
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the proportion of patients with controlled office blood
pressure (OBP) (ie, <140/90 mm Hg or <130/80 mm Hg if diabetes or chronic
kidney disease is present) at 12 months.
Secondary outcome
Secondary outcome parameters are: home blood pressure, health-related quality
of life, self-management characteristics, patient utilities and
costs-effectiveness.
Background summary
Raised blood pressure is highly important as a risk factor for cardiovascular
comorbidity and mortality world-wide. Despite the availability of effective
therapy, many patients with hypertension are still undiscovered or not
adequately treated, resulting in high rates of poorly controlled hypertension..
Home based blood monitoring may provide a useful tool to improve the control of
blood pressure. In addition, the availability of novel innovative e-health
techniques may enhance self-management in a way the patient participates in the
prevention of progression of his or her own disease. However, the effectiveness
of lowering blood pressure using digital self-management support in combination
with home blood pressure monitoring in patients with uncontrolled hypertension
has not been determined yet.
Study objective
To assess the one-year (cost)effectiveness of telemonitoring of blood pressure
and self-management support via an internet-based service in addition to usual
care as compared to usual care alone in a pragmatic trial in patients with
uncontrolled hypertension.
Study design
Pragmatic Randomised Controlled Trial
Intervention
Intervention group will receive telemonitoring and internet-based
self-management support for hypertension (TISH) focussed on blood pressure and
cardiovascular risk factors with the PatientCoach-platform during one-year
additional to usual care. Control-group will receive usual care alone.
Study burden and risks
Patients in the intervention group will receive blood pressure monitor and will
be familiarised with PatientCoach shortly after randomisation and patients will
be asked to measure blood pressure twice in the morning and evening three times
weekly. Every three months all participants will digitally receive a set of
questionnaires, which can be filled out using a personal computer with internet
connection.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- Patients with hypertension, with a systolic blood pressure > 140 mmHg
- Patients who are willing to measure their blood pressure at home
- Access to internet at home and ability to use it
Exclusion criteria
- Relevant somatic or psychiatric co-morbidity that interferes with the study
- Systolic blood pressure >200 mm Hg
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL45863.058.13 |