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Mobile Phone in Hypertension Management

Primary Purpose

Hypertension

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

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

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring Self-report, Self-management, Hypertension, Adherence, Cell phone, Drug treatment, Medical Adherence

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Gothenburg

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Self-report

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Systolic blood pressure

Change in systolic blood pressure

Full Information

NCT ID

NCT01510301

First Posted

January 11, 2012

Last Updated

September 14, 2016

Sponsor

Göteborg University

1. Study Identification

Unique Protocol Identification Number

NCT01510301

Brief Title

Mobile Phone in Hypertension Management

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Göteborg University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Self-report, Self-management, Hypertension, Adherence, Cell phone, Drug treatment, Medical Adherence

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Self-report

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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 Measure Information:

Title

Adherence to antihypertensive medication

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Systolic blood pressure

Description

Change in systolic blood pressure

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karin I Kjellgren, professor

Organizational Affiliation

Göteborg University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Gothenburg

City

Gothenburg

State/Province

Box 457

ZIP/Postal Code

40530

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

24564289

Citation

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.

Results Reference

result

PubMed Identifier

24786778

Citation

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.

Results Reference

result

PubMed Identifier

24910510

Citation

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.

Results Reference

result

PubMed Identifier

25903164

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.

Results Reference

result

PubMed Identifier

26456490

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.

Results Reference

result

PubMed Identifier

26462732

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. No abstract available.

Results Reference

result

PubMed Identifier

30139897

Citation

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.

Results Reference

derived

PubMed Identifier

29343156

Citation

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.

Results Reference

derived

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Mobile Phone in Hypertension Management

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