Hypertension,EssentialNCT03908710
The Accumbo Home Blood Pressure Trial
A study testing Treatment of hypertension using blood pressure self-measurement at home in people with Hypertension,Essential, run by Accumbo AB at 1 site in Sweden.
Trial summary
Aim of the study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system,a smartphone patient app and a home blood pressure monitor. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Hypertension,Essential
- What is being tested?
- Treatment of hypertension using blood pressure self-measurement at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2018to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary hypertension
- Smartphone at home
Who cannot join
- Secondary hypertension,
- previous stroke,
- myocardial infarction,
- known heart failure,
- known cardiac arrhytmia,
- known servere renal failure,
- known dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Trial of Home Blood Pressure Levels in Hypertensive Participants Using the ACCUMBO Telemedicine Device
Aim of the study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system,a smartphone patient app and a home blood pressure monitor.
Read the detailed description
Despite the extensive knowledge of the importance of treating and thus preventing complications of hypertension, the incidence of high blood pressure is increasing, and it is still the main cause of cardiovascular disease and premature death, partly due to deficiencies in preventive care and control of the disease in an aging world. Blood pressure values obtained by self-measurement at home (HBPM) have been shown to predict the cardiovascular prognosis equally well as or better than blood pressure values obtained in the clinic (CBPM) in several observational studies. Aim of the present study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system and a electronic health record, a patient app and a home blood pressure monitor. " The patient app and the doctor's record reflect each other and basically contain the same information. Doctors can treat their patients remotely and the patients are able to manage some health issues by themselves by using the applications. Some patients need the physical examination. We therefore included patients after a so-called triage step with medical questions.
- Conditions
- Hypertension,Essential
- Being tested
- Treatment of hypertension using blood pressure self-measurement at home
- Keywords
- Home blood pressure monitor, Telemedicine, mHealth, eHealth
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of hypertension using blood pressure self-measurement at homeOther
The primary aim of the present study is to investigate whether home blood pressure recording via Bluetooth and continuous communication between doctor and patient will give improved blood pressure values when comparing the initial values with the blood pressure values recorded after 3 months. Secondary examinations include treatment of hypotension and adverse events, the patient's experience, the user's potential problems with the blood pressure cuff, app downloading, problems with history issues or problems with technical
| Study group | Role | What they receive |
|---|---|---|
| home Home blood pressure levels in hypertensive participants | Other | Only one arm. No control group. Receives: Other: Treatment of hypertension using blood pressure self-measurement at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor
We investigate if the blood pressure is better in the end of the study compared with the start
Measured: 3 months
Patient experience
We investigate how the patients experience the medical technology system and the treatment using a questionnaire
Measured: 3 months
Secondary outcomes (1)
Hypotension
We investigate how many patients have hypotension/ortosstatism in the beginning of the study compared in the end of the study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Jun 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accumbo AB
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping
- Responsible party
- Sponsor
- Investigators
- Martin Carlsson, MD,PhD, Principal investigator, Accumbo AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908710
- Sponsor's protocol ID
- Accumbo AB (Accumbo)
- Status last verified
- Apr 2019
- First submitted
- 7 Apr 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Home Blood Pressure Levels in Hypertensive Participants Using the ACCUMBO Telemedicine Device
- ClinicalTrials.gov ID
- NCT03908710
- Acronym / sponsor ID
- Accumbo AB (Accumbo)
- Conditions
- Hypertension,Essential
- Keywords
- Home blood pressure monitor, Telemedicine, mHealth, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Accumbo ABUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system,a smartphone patient app and a home blood pressure monitor.
Detailed description
Despite the extensive knowledge of the importance of treating and thus preventing complications of hypertension, the incidence of high blood pressure is increasing, and it is still the main cause of cardiovascular disease and premature death, partly due to deficiencies in preventive care and control of the disease in an aging world. Blood pressure values obtained by self-measurement at home (HBPM) have been shown to predict the cardiovascular prognosis equally well as or better than blood pressure values obtained in the clinic (CBPM) in several observational studies. Aim of the present study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system and a electronic health record, a patient app and a home blood pressure monitor. " The patient app and the doctor's record reflect each other and basically contain the same information. Doctors can treat their patients remotely and the patients are able to manage some health issues by themselves by using the applications. Some patients need the physical examination. We therefore included patients after a so-called triage step with medical questions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| home Home blood pressure levels in hypertensive participants | Other | Other: Treatment of hypertension using blood pressure self-measurement at homeOnly one arm. No control group. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary hypertension
- Smartphone at home
Key exclusion criteria (7 listed)
- Secondary hypertension,
- previous stroke,
- myocardial infarction,
- known heart failure,
- known cardiac arrhytmia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of hypertension using blood pressure self-measurement at homeThe primary aim of the present study is to investigate whether home blood pressure recording via Bluetooth and continuous communication between doctor and patient will give improved blood pressure values when comparing the initial values with the blood pressure values recorded after 3 months. Secondary examinations include treatment of hypotension and adverse events, the patient's experience, the user's potential problems with the blood pressure cuff, app downloading, problems with history issues or problems with technical | Other | home Home blood pressure levels in hypertensive participants |
Primary outcome
Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor
Time frame: 3 months
We investigate if the blood pressure is better in the end of the study compared with the start
Patient experience
Time frame: 3 months
We investigate how the patients experience the medical technology system and the treatment using a questionnaire
1 secondary outcome
Hypotension
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Carlsson, MD,PhD principal investigator
Accumbo AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment of hypertension using blood pressure self-measurement at home in people with Hypertension,Essential, run by Accumbo AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.