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Mobile Phone in Hypertension Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510301
First Posted: January 16, 2012
Last Update Posted: September 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Göteborg University
January 11, 2012
January 16, 2012
September 15, 2016
March 2012
June 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01510301 on ClinicalTrials.gov Archive Site
Systolic blood pressure [ Time Frame: 8 weeks ]
Change in systolic blood pressure
Same as current
Not Provided
Not Provided
 
Mobile Phone in Hypertension Management
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Hypertension
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.
Self-report
Intervention: Device: Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
June 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01510301
MIHM
Yes
Not Provided
Not Provided
Göteborg University
Göteborg University
Not Provided
Principal Investigator: Karin I Kjellgren, professor Göteborg University
Göteborg University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP