Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobile Phone in Hypertension Management

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.
 
ClinicalTrials.gov Identifier: NCT01510301
Recruitment Status : Completed
First Posted : January 16, 2012
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Device: Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mastery and Autonomy in Management of Hypertension With a Mobile Self-report System
Study Start Date : March 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Self-report 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: 8 weeks ]
    Change in systolic blood pressure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510301


Locations
Layout table for location information
Sweden
University of Gothenburg
Gothenburg, Box 457, Sweden, 40530
Sponsors and Collaborators
Göteborg University
Investigators
Layout table for investigator information
Principal Investigator: Karin I Kjellgren, professor Göteborg University
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01510301    
Other Study ID Numbers: MIHM
First Posted: January 16, 2012    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Keywords provided by Göteborg University:
Self-report
Self-management
Hypertension
Adherence
Cell phone
Drug treatment
Medical Adherence
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases