HypertensionNCT01510301
Mobile Phone in Hypertension Management
A study testing Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM) in people with Hypertension, run by Göteborg University at 1 site in Sweden.
Trial summary
The purpose of this study is to examine if a mobile phone-based self-report system, using the patient's own mobile phone, will improve adherence to treatment of hypertension and lead to personal involvement of the patient in the treatment. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2012to Jun 2012
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of arterial hypertension
- Prescribed antihypertensive treatment
- Alert and oriented
- Swedish-speaking
- Access to a functioning cell phone
- Agreeing to regular controls at the National Prescribed Drug Register of drugs
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mastery and Autonomy in Management of Hypertension With a Mobile Self-report System
The purpose of this study is to examine if a mobile phone-based self-report system, using the patient's own mobile phone, will improve adherence to treatment of hypertension and lead to personal involvement of the patient in the treatment.
- Conditions
- Hypertension
- Being tested
- Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM)
- Keywords
- Self-report, Self-management, Hypertension, Adherence, Cell phone, Drug treatment, Medical Adherence
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM)Device
To test an electronic Patient-Reported Outcomes Measure (e-PROM) intended to assess patients' daily perceptions of symptoms and wellbeing, as well as self-measured blood pressure, treatment side-effects and medicine intake;
- Explore patient interactions (learning and understanding) with an internet-reporting system providing structured feedback of e-PROM results to examine if such feedback is useful in improving adherence;
- Explore patient-physician/nurse interactions to examine if structured feedback of e-PROM results serves as a useful complement to support consultations regarding treatment monitoring and adherence.
| Study group | Role | What they receive |
|---|---|---|
| Self-report | Other | Not described Receives: Device: Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to antihypertensive medication
Adherence to antihypertensive medication will be checked through a question in the cell phone and evaluation of patient´s use of antihypertensive medication will be checked from the National Prescribed Drug Register of drugs. Twenty patient-physician/nurse consultations will be audio/video-recorded at regularly scheduled appointments to obtain authentic evidence of the use of the self-reports in clinical practice. The outcomes will include blood pressure measurement, registration of self-reported symptoms and discourse analyses.
Measured: 8 weeks
Secondary outcomes (1)
Systolic blood pressure
Change in systolic blood pressure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin I Kjellgren, professor, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510301
- Sponsor's protocol ID
- MIHM
- Status last verified
- Sep 2016
- First submitted
- 11 Jan 2012
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bengtsson U, Kasperowski D, Ring L, Kjellgren K. Developing an interactive mobile phone self-report system for self-management of hypertension. Part 1: patient and professional perspectives. Blood Press. 2014 Oct;23(5):288-95. doi: 10.3109/08037051.2014.883203. Epub 2014 Feb 24.
PubMed 24564289Bengtsson U, Kjellgren K, Hofer S, Taft C, Ring L. Developing an interactive mobile phone self-report system for self-management of hypertension. Part 2: content validity and usability. Blood Press. 2014 Oct;23(5):296-306. doi: 10.3109/08037051.2014.901009. Epub 2014 May 1.
PubMed 24786778Hallberg I, Taft C, Ranerup A, Bengtsson U, Hoffmann M, Hofer S, Kasperowski D, Makitalo A, Lundin M, Ring L, Rosenqvist U, Kjellgren K. Phases in development of an interactive mobile phone-based system to support self-management of hypertension. Integr Blood Press Control. 2014 May 7;7:19-28. doi: 10.2147/IBPC.S59030. eCollection 2014.
PubMed 24910510Hallberg I, Ranerup A, Kjellgren K. Supporting the self-management of hypertension: Patients' experiences of using a mobile phone-based system. J Hum Hypertens. 2016 Feb;30(2):141-6. doi: 10.1038/jhh.2015.37. Epub 2015 Apr 23.
PubMed 25903164Bengtsson U, Kjellgren K, Hallberg I, Lindwall M, Taft C. Improved Blood Pressure Control Using an Interactive Mobile Phone Support System. J Clin Hypertens (Greenwich). 2016 Feb;18(2):101-8. doi: 10.1111/jch.12682. Epub 2015 Oct 12.
PubMed 26456490Ruiz-Hurtado G, Ruilope LM. New Strategy to Control Blood Pressure: Interactive Mobile Phone Support. J Clin Hypertens (Greenwich). 2016 Feb;18(2):109-10. doi: 10.1111/jch.12683. Epub 2015 Oct 14. No abstract available.
PubMed 26462732Taft C, Hallberg I, Bengtsson U, Manhem K, Kjellgren K. Links between blood pressure and medication intake, well-being, stress, physical activity and symptoms reported via a mobile phone-based self-management support system: a cohort study in primary care. BMJ Open. 2018 Aug 23;8(8):e020849. doi: 10.1136/bmjopen-2017-020849.
PubMed 30139897Bengtsson U, Kjellgren K, Hallberg I, Lundin M, Makitalo A. Patient contributions during primary care consultations for hypertension after self-reporting via a mobile phone self-management support system. Scand J Prim Health Care. 2018 Mar;36(1):70-79. doi: 10.1080/02813432.2018.1426144. Epub 2018 Jan 18.
PubMed 29343156
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastery and Autonomy in Management of Hypertension With a Mobile Self-report System
- ClinicalTrials.gov ID
- NCT01510301
- Acronym / sponsor ID
- MIHM
- Conditions
- Hypertension
- Keywords
- Self-report, Self-management, Hypertension, Adherence, Cell phone, Drug treatment, Medical Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Jan 2012 (estimated)
- 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.
The purpose of this study is to examine if a mobile phone-based self-report system, using the patient's own mobile phone, will improve adherence to treatment of hypertension and lead to personal involvement of the patient in the treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-report | Other | Device: Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of arterial hypertension
- Prescribed antihypertensive treatment
- Alert and oriented
- Swedish-speaking
- Access to a functioning cell phone
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM)To test an electronic Patient-Reported Outcomes Measure (e-PROM) intended to assess patients' daily perceptions of symptoms and wellbeing, as well as self-measured blood pressure, treatment side-effects and medicine intake; * Explore patient interactions (learning and understanding) with an internet-reporting system providing structured feedback of e-PROM results to examine if such feedback is useful in improving adherence; * Explore patient-physician/nurse interactions to examine if structured feedback of e-PROM results serves as a useful complement to support consultations regarding treatment monitoring and adherence. | Device | Self-report |
Primary outcome
Adherence to antihypertensive medication
Time frame: 8 weeks
Adherence to antihypertensive medication will be checked through a question in the cell phone and evaluation of patient´s use of antihypertensive medication will be checked from the National Prescribed Drug Register of drugs. Twenty patient-physician/nurse consultations will be audio/video-recorded at regularly scheduled appointments to obtain authentic evidence of the use of the self-reports in clinical practice. The outcomes will include blood pressure measurement, registration of self-reported symptoms and discourse analyses.
1 secondary outcome
Systolic blood pressure
Time frame: 8 weeks
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 15 Sep 2016.
- Results publication: PubMed 24564289Bengtsson U, Kasperowski D, Ring L, Kjellgren K. Developing an interactive mobile phone self-report system for self-management of hypertension. Part 1: patient and professional perspectives. Blood Press. 2014 Oct;23(5):288-95. doi: 10.3109/08037051.2014.883203. Epub 2014 Feb 24.
- Results publication: PubMed 24786778Bengtsson U, Kjellgren K, Hofer S, Taft C, Ring L. Developing an interactive mobile phone self-report system for self-management of hypertension. Part 2: content validity and usability. Blood Press. 2014 Oct;23(5):296-306. doi: 10.3109/08037051.2014.901009. Epub 2014 May 1.
- Results publication: PubMed 24910510Hallberg I, Taft C, Ranerup A, Bengtsson U, Hoffmann M, Hofer S, Kasperowski D, Makitalo A, Lundin M, Ring L, Rosenqvist U, Kjellgren K. Phases in development of an interactive mobile phone-based system to support self-management of hypertension. Integr Blood Press Control. 2014 May 7;7:19-28. doi: 10.2147/IBPC.S59030. eCollection 2014.
- Results publication: PubMed 25903164Hallberg I, Ranerup A, Kjellgren K. Supporting the self-management of hypertension: Patients' experiences of using a mobile phone-based system. J Hum Hypertens. 2016 Feb;30(2):141-6. doi: 10.1038/jhh.2015.37. Epub 2015 Apr 23.
- Results publication: PubMed 26456490Bengtsson U, Kjellgren K, Hallberg I, Lindwall M, Taft C. Improved Blood Pressure Control Using an Interactive Mobile Phone Support System. J Clin Hypertens (Greenwich). 2016 Feb;18(2):101-8. doi: 10.1111/jch.12682. Epub 2015 Oct 12.
- Results publication: PubMed 26462732Ruiz-Hurtado G, Ruilope LM. New Strategy to Control Blood Pressure: Interactive Mobile Phone Support. J Clin Hypertens (Greenwich). 2016 Feb;18(2):109-10. doi: 10.1111/jch.12683. Epub 2015 Oct 14. No abstract available.
- Derived from this study: PubMed 30139897Taft C, Hallberg I, Bengtsson U, Manhem K, Kjellgren K. Links between blood pressure and medication intake, well-being, stress, physical activity and symptoms reported via a mobile phone-based self-management support system: a cohort study in primary care. BMJ Open. 2018 Aug 23;8(8):e020849. doi: 10.1136/bmjopen-2017-020849.
- Derived from this study: PubMed 29343156Bengtsson U, Kjellgren K, Hallberg I, Lundin M, Makitalo A. Patient contributions during primary care consultations for hypertension after self-reporting via a mobile phone self-management support system. Scand J Prim Health Care. 2018 Mar;36(1):70-79. doi: 10.1080/02813432.2018.1426144. Epub 2018 Jan 18.
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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.
Karin I Kjellgren, professor principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM) in people with Hypertension, run by Göteborg University 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 6 inclusion and 0 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 15 Sep 2016. 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?
Adherence to antihypertensive medication (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01510301, which also lists 8 linked publications.
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 15 Sep 2016; AzTrials last refreshed its copy on 6 Nov 2026.