Mobile Phone in Hypertension Management

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01510301
First received: January 11, 2012
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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 Intervention
Hypertension
Device: Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Mastery and Autonomy in Management of Hypertension With a Mobile Self-report System

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Adherence to antihypertensive medication [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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:
  • Systolic blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change in systolic blood pressure


Enrollment: 51
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510301

Locations
Sweden
University of Gothenburg
Gothenburg, Box 457, Sweden, 40530
Sponsors and Collaborators
Göteborg University
Investigators
Principal Investigator: Karin I Kjellgren, professor Göteborg University
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01510301     History of Changes
Other Study ID Numbers: MIHM
Study First Received: January 11, 2012
Last Updated: August 3, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
Self-report
Self-management
Hypertension
Adherence
Cell phone
Drug treatment
Medical Adherence

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014