Mobile Phone in Hypertension Management

Hypertension Clinical Trial

Official title:

Mastery and Autonomy in Management of Hypertension With a Mobile Self-report System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510301
• Other study ID #: MIHM
• Status: Completed
• Phase: N/A
• First received: January 11, 2012
• Last updated: September 14, 2016
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: September 2016
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Sweden	University of Gothenburg	Gothenburg	Box 457

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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: 10.3109/08037051.2014.8 — View Citation

Bengtsson 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. — View Citation

Bengtsson U, Kjellgren K, Höfer 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: 10.3109/08037051.2014.90100 — View Citation

Hallberg 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. — View Citation

Hallberg I, Taft C, Ranerup A, Bengtsson U, Hoffmann M, Höfer S, Kasperowski D, Mäkitalo 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 B — View Citation

Ruiz-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks	No
Secondary	Systolic blood pressure	Change in systolic blood pressure	8 weeks	No