NCT01510301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

January 11, 2012

Last Update Submit

September 14, 2016

Conditions

Keywords

Self-reportSelf-managementHypertensionAdherenceCell phoneDrug treatmentMedical Adherence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Systolic blood pressure

    8 weeks

Study Arms (1)

Self-report

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

Interventions

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

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Gothenburg

Gothenburg, Box 457, 40530, Sweden

Location

Related Publications (8)

  • 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.

  • Bengtsson 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.

  • Hallberg 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.

  • 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.

  • 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.

  • 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. No abstract available.

  • Taft 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.

  • Bengtsson 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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Karin I Kjellgren, professor

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 16, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations