To determine the effects of the PCP+SM compared with usual care on BP control in adults with hypertension. To determine the effects of the PCP+SM compared with usual care on antihypertensive medication use in adults with hypertension. To determine…
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Proportion of patients with adequately controlled blood pressure (<140/90) at
6 months
Secondary outcome
Blood pressure control
o Proportion of patients with adequately controlled blood pressure at 6 weeks
and 12 months.
o Differences in mean systolic and mean diastolic blood pressure after 6 weeks
6 and 12 months.
Medication use
o Biochemical assessment of antihypertensive medication concentrations in blood
at baseline, 6 weeks, 6 months and 12 months.
o Number of antihypertensive agents used at 6 months and 12 months.
o Number of antihypertensive medication changes (increases or substitution) at
6 months and 12 months.
o Defined daily doses (DDD) of antihypertensive medication used at 6 months and
12 months.
Self-management
o Frequency of home blood pressure measurements per month
o Proportion of months where a blood pressure reading is obtained
o Self-efficacy to monitor and control high blood pressure
o Effect of coaching on disease insight and skills with EQ-5D-5L + PAM-13
questionnaires at inclusion and at 6 and 12 months.
Satisfaction
o Patient satisfaction with MHealth and TUQ questionnaires at 6 months.
o Doctor satisfaction with TUQ questionnaire at 6 months.
Other parameters correlated with lifestyle and endothelial function (both
groups)
o BMI and waist circumference at baseline and at 6 months and 12 months
o Biochemical assessment of lipid metabolism with total cholesterol, LDL-C,
HDL-C and triglycerides (mmol/L) at baseline, 6 weeks, 6 months and 12 months.
o Biochemical assessment of glucose metabolism using HbA1c in mmol/L and
mmol/mol and renal function and electrolytes (creatinine, Gfr, Na and K),
respectively at baseline, 6 weeks, 6 months and 12 months.
Adverse events
o Hospitalization by hypertensive urgency/crisis, cardiovascular death,
myocardial infarction, or ischemic stroke) and hospitalization for heart
failure.
o Serious adverse events and adverse events leading to changes and/or
discontinuation of hypertension medication.
Lifestyle behaviors
o BMI and waist circumference at baseline and at 6 months and 12 months
o Biochemical assessment of lipid metabolism with total cholesterol, LDL-C,
HDL-C and triglycerides (mmol/L)
o Biochemical assessment of glucose metabolism using HbA1c in mmol/L and
mmol/mol, respectively
o Smoking and self reported physical activity
Costs
Direct-medical costs
o Costs related to HBPT (blood pressure monitor costs)
o Costs related to additional prescribing of antihypertensive drugs
o Costs related to a physical appointment for patients in a hypertension care
pathway
o Costs related to reimbursement for patients in a HBPT program
o Costs related to hospital admissions resulting primarily from poorly
controlled hypertension or hypertensive emergencies.
o Costs related to hospital admissions or required care pathways following a
cardiovascular complication as a result from poorly controlled hypertension
o Future related medical costs
Direct-non medical costs
o Training costs related to the use of HBPT for both telenurses, nurse
specialists and clinicians
o Development and exploitation costs (time spent developing the HBPT protocol,
license costs for the application)
o Salaries for involved health care providers during HBPT
Indirect Non-Medical costs
o Costs related to work absence (loss of productivity for short-term absence,
friction cost for long-term absence)
o Costs related to the hospital visit (travel costs, parking costs)
Indirect medical costs
o Future unrelated medical costs (as calculated using the iMTA PAID module:
costs related to other diseases due to improved life expectancy)
Background summary
Hypertension is the most significant risk factor for cardiovascular disease.
Strategies leading to more effective lowering of blood pressure result in a
greater reduction in risk. In the Netherlands, around 20% of the adult Dutch
population were classified as hypertensive, and >50% of those eligible for
treatment had uncontrolled blood pressure levels despite antihypertensive
medication . As telemonitoring has become indispensable during the COVID-19
pandemic, self-monitoring (SM) of hypertension have been shown to be of benefit
in improving this suboptimal control rate. (Automated) coaching strategies on
top of SM, such as personal counseling programs (PCP) through smartphone apps
might further enhance hypertension management, however limited data is
available. Our purpose is to determine whether PCP+SM compared with usual care
improves BP control in adults with hypertension.
Study objective
To determine the effects of the PCP+SM compared with usual care on BP control
in adults with hypertension.
To determine the effects of the PCP+SM compared with usual care on
antihypertensive medication use in adults with hypertension.
To determine the effects of the PCP+SM compared with usual care on hypertension
self-management among adults with hypertension.
To determine the effects of the PCP+SM compared with usual care on patient and
health care worker satisfaction
To determine the effects the PCP+SM SM compared with usual care on adverse
events
To determine the effects of the PCP+SM compared with usual care on healthy
lifestyle behaviors among adults with hypertension.
To determine the effects of the PCP+SM compared with usual care on health care
costs and work requirements among adults with hypertension.
Study design
The study is a non-blinded randomized controlled clinical trial. After METC
approval, patients 400 patients will be included from the emergency room or the
outpatient department with hypertension (RR>140/90). The study will take place
in a multicenter setting in the Netherlands in the Maasstad Hospital
(Rotterdam), Franciscus Hospital (Gasthuis in Rotterdam and Vlietland in
Schiedam), Erasmus Medical Center (Rotterdam) and Albert Schweitzer Hospital
(Dordrecht).
Intervention
Intervention group will be provided with a smartphone app and home blood
pressure monitor. During the study period they will measure their blood
pressure at home, add values to the app to allow for remote monitoring by the
health care professional. The app is programmed with certain alarms and
thresholds to allow for pro-active monitoring (and potentially change the
medical treatment or optimize lifestyle factors). The app also consists of
certain E-coaching modules to improve lifestyle factors.
Study burden and risks
Patients in the both the intervention and the control group will be seen on
outpatients visits after 6 weeks, 6 months and 12 months following inclusion.
These are regulair outpatients department visits. The length of these visits
will be relatively increased due to the nature of the blood pressure
measurements that will be performed. Patients will participate in a dried blood
spot measurement (T=0, T= 6 weeks, T=6 months and T=12 months). They will also
provide 24 hour urine samples (2x) and undergo a venous blood sample analysis
at 6 weeks, 6 months and 12 months. These venous blood sample analysis are part
of usual care.
There is no risk associated with participating in this study. There is however
a small increase in time required by participants as they will perform blood
pressure measurements relatively frequent.
Maasstadweg 21
Rotterdam 3079DZ
NL
Maasstadweg 21
Rotterdam 3079DZ
NL
Listed location countries
Age
Inclusion criteria
- Patients >18 years with hypertension (>140/90) will be included after their
emergency department or outpatient clinic visit. - Have and use a smartphone or
a partner/caregiver who is able to provide the necessary technical support -
Able to provide written informed consent prior to participation in the study
Exclusion criteria
- Current user of the iHealth Track blood pressure monitor and Luscii app -
Persistent atrial fibrillation as indicated in the electronic health record
(EHR) - Pregnant or planning to become pregnant during the study period -
Severe kidney disease, defined as estimated glomerular filtration rate <30 per
1.73 m2 or currently on renal replacement therapy (i.e. hemodialysis or
peritoneal dialysis) - Unable to communicate (not language specific) - History
of a cardiovascular event (ischemic stroke, transient ischemic attack,
myocardial infarction, coronary artery bypass grafting) in the past 3 months -
Diagnosis of dementia, psychosis as indicated in the electronic health record -
Life expectancy <1 year (eg Terminal cancer diagnosis or NYHA III or IV heart
failure) - Individuals requiring BP monitor cuff size larger than 42cm -
Patients with very obvious clinical clues for a secondary cause of their
hypertension (e.g. excessive licorice use, proven renal artery stenosis etc)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82758.100.22 |