Danish Evaluation of Your Heart Forecast.

NCT04058847 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2022-05-23

No results posted yet for this study

Summary

Under 50% of patients diagnosed with hypertension and treated in general practice, have reached a blood pressure within the recommended levels of the national guideline. Compliance is the main problem for these patients, but effective tools for increasing patient compliance are missing. The objective is to evaluate the risk-assessment and risk-communication tool: "Your Heart Forecast", to see if it can improve patient compliance, health literacy and empowerment.

Patients will be followed in a cluster-randomised controlled trial in the setting of general practice, using surveys at inclusion and after 6 and 12 months. Besides surveys, the participants' blood pressure will be measured as a hard outcome and data will be drawn from various patient databases. After 6 months, qualitative interviews will be conducted, with a subgroup of patients from the intervention group.

It is expected to find whether the use of Your Heart Forecast can lower patients' blood pressure and/or increase their compliance, health literacy and empowerment. The aim is to show if an increase in general health literacy and patient empowerment, as measured by Patient Activation Measure(PAM13) can be seen.

The investigators hope to reveal whether this software can improve patient compliance and thereby be a reasonable tool to implement in the national blood pressure control program. In further studies, it should be shown if the cost of using this program is far less than expenses for hospitalisation due to complications and comorbidity to hypertension.

Conditions

  • Risk Communication
  • Cardiovascular Risk Factor

Interventions

OTHER

Your Heart Forecast

1 year follow up with Your Heart Forecast and a follow-up email every 2 weeks.

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER
  • Odense Patient Data Explorative Network

    collaborator OTHER
  • ENIGMA Solutions Limited

    collaborator UNKNOWN
  • Lilly & Herbert Hansens Foundation

    collaborator UNKNOWN
  • The A. P. Møller and Chastine McKinney Møller Foundation

    collaborator UNKNOWN
  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Jesper B Nielsen, Professor, PhD · Research Unit of General Practice, University of Southern Denmark

  • Anders E Jensen, M.D. · Research Unit of General Practice, University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-27
Primary Completion
2022-10-31
Completion
2022-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04058847 on ClinicalTrials.gov