Danish Evaluation of Your Heart Forecast.

NCT04058847 | Unknown

• 1 other identifier: S-20170206
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Risk communication; CVD-risk; General practice; Primary care; Visual communication; Interactive communication; Cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Health literacy

  Self-reported change in health literacy through questionnaires.

  Questionnaire sent out at inclusion, after 6 months and after 1 year

Secondary Outcomes (4)

• Blood pressure

  Calculated after the 1 year trial period

• Adherence

  Questionnaire sent out at inclusion, after 6 months and after 1 year

• Empowerment

  Questionnaire sent out at inclusion, after 6 months and after 1 year

• Number of contacts

  Counted after end of 1 year trial period.

Study Arms (2)

Intervention

EXPERIMENTAL

Use of Your Heart Forecast and an e-mail follow up-program.

Other: Your Heart Forecast

Control

NO INTERVENTION

The control group uses standard regime (business as usual).

Interventions

Your Heart Forecast OTHER

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

Intervention

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must understand and read Danish and must be cognitively well functioning.
• The patient must have Internet access, host an email address and read their emails on regular basis (at least once a week).
• All included patients must be diagnosed with hypertension and go to regular blood pressure control consultations at their GP (at least once a year).
• Both patients with known hypertension and those newly discovered are accepted into the trial.
• Age from 35 to 75 years (both included).
• Both genders are included.

You may not qualify if:

• If the patient during the trial develops prolonged illness so severe that treatment of hypertension is no longer a priority, he/she will be excluded.
• Patients with blood pressure above 170/100 are excluded, as these patients should receive intensive blood pressure treatment regardless of their predicted CVD risk or heart age.
• Pregnancy.
• Very high cholesterol (TCL or TCL/HDL 8 or over).
• Genetic lipid disorders.
• If the patient is diabetic AND has a complicating kidney disease.
• Known problems with arteries to the legs defined as:
• Clinical symptoms of claudication
• Diminished foot pulses
• Carotid bruits
• Radiological evidence
• Prior surgery /percutaneous interventions
• Prior stroke or mini-stroke (TIA).
• Angina, prior AMI or heart related operation.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Region of Southern Denmark: collaborator
• Odense Patient Data Explorative Network: collaborator
• ENIGMA Solutions Limited: collaborator
• Lilly & Herbert Hansens Foundation: collaborator
• The A. P. Møller and Chastine McKinney Møller Foundation: collaborator

Study Sites (1)

Research Unit of General Practice, Department of Public Health, University of Southern Denmark

Odense, Region Syddanmark, 5000, Denmark

Location

Related Publications (14)

• Reuther LO, Paulsen MS, Andersen M, Schultz-Larsen P, Christensen HR, Munck A, Larsen PV, Damsgaard J, Poulsen L, Hansen DG, Christensen B, Sondergaard J. Is a targeted intensive intervention effective for improvements in hypertension control? A randomized controlled trial. Fam Pract. 2012 Dec;29(6):626-32. doi: 10.1093/fampra/cms031. Epub 2012 May 7.

  PMID: 22565110 BACKGROUND

• Soureti A, Hurling R, Murray P, van Mechelen W, Cobain M. Evaluation of a cardiovascular disease risk assessment tool for the promotion of healthier lifestyles. Eur J Cardiovasc Prev Rehabil. 2010 Oct;17(5):519-23. doi: 10.1097/HJR.0b013e328337ccd3.

  PMID: 20195154 BACKGROUND

• Pedersen KM, Andersen JS, Sondergaard J. General practice and primary health care in Denmark. J Am Board Fam Med. 2012 Mar;25 Suppl 1:S34-8. doi: 10.3122/jabfm.2012.02.110216.

  PMID: 22403249 BACKGROUND

• Brust-Renck PG, Royer CE, Reyna VF. Communicating Numerical Risk: Human Factors That Aid Understanding in Health Care. Rev Hum Factors Ergon. 2013 Oct;8(1):235-276. doi: 10.1177/1557234X13492980.

  PMID: 24999307 BACKGROUND

• Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011 Jul 19;155(2):97-107. doi: 10.7326/0003-4819-155-2-201107190-00005.

  PMID: 21768583 BACKGROUND

• Wells S, Kerr A, Eadie S, Wiltshire C, Jackson R. 'Your Heart Forecast': a new approach for describing and communicating cardiovascular risk? Heart. 2010 May;96(9):708-13. doi: 10.1136/hrt.2009.191320. No abstract available.

  PMID: 20424153 BACKGROUND

• De Geest S, Sabate E. Adherence to long-term therapies: evidence for action. Eur J Cardiovasc Nurs. 2003 Dec;2(4):323. doi: 10.1016/S1474-5151(03)00091-4. No abstract available.

  PMID: 14667488 BACKGROUND

• Maindal HT, Sokolowski I, Vedsted P. Translation, adaptation and validation of the American short form Patient Activation Measure (PAM13) in a Danish version. BMC Public Health. 2009 Jun 29;9:209. doi: 10.1186/1471-2458-9-209.

  PMID: 19563630 BACKGROUND

• Sorensen K, Pelikan JM, Rothlin F, Ganahl K, Slonska Z, Doyle G, Fullam J, Kondilis B, Agrafiotis D, Uiters E, Falcon M, Mensing M, Tchamov K, van den Broucke S, Brand H; HLS-EU Consortium. Health literacy in Europe: comparative results of the European health literacy survey (HLS-EU). Eur J Public Health. 2015 Dec;25(6):1053-8. doi: 10.1093/eurpub/ckv043. Epub 2015 Apr 5.

  PMID: 25843827 BACKGROUND

• Perestelo-Perez L, Rivero-Santana A, Boronat M, Sanchez-Afonso JA, Perez-Ramos J, Montori VM, Serrano-Aguilar P. Effect of the statin choice encounter decision aid in Spanish patients with type 2 diabetes: A randomized trial. Patient Educ Couns. 2016 Feb;99(2):295-9. doi: 10.1016/j.pec.2015.08.032. Epub 2015 Sep 1.

  PMID: 26343571 BACKGROUND

• Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997 Sep-Oct;12(1):38-48. doi: 10.4278/0890-1171-12.1.38.

  PMID: 10170434 BACKGROUND

• Madsbad S, Larsen ML, Adeler HF, Kryhlmand M, Westergaard M. [Implementation of clinical guidelines in general practice. The effect of journal audit and continuing education for the treatment of cardiovascular risk factors in patients with and without type 2 diabetes]. Ugeskr Laeger. 2006 Apr 24;168(17):1640-5. Danish.

  PMID: 16674875 BACKGROUND

• Stjernholm K, Andersen HS, Jensen AE, Nielsen JB. Danish evaluation of Your Heart Forecast: a cluster randomised controlled trial aimed at improving modifiable risk factors of CVD. Open Heart. 2026 Jan 28;13(1):e003812. doi: 10.1136/openhrt-2025-003812.

  PMID: 41605571 DERIVED

• Jensen AE, Sondergaard J, Kjaer NK, Jackson R, Nielsen JB. Danish Evaluation of Your Heart Forecast (DANY): study protocol for a cluster randomised controlled trial on an interactive risk-communication tool aimed at improving adherence of patients with high blood pressure. Trials. 2020 Jan 3;21(1):11. doi: 10.1186/s13063-019-3886-2.

  PMID: 31900231 DERIVED

Study Officials

• Jesper B Nielsen, Professor, PhD

  Research Unit of General Practice, University of Southern Denmark

  STUDY CHAIR

• Anders E Jensen, M.D.

  Research Unit of General Practice, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Principal Investigator

Model Details: Cluster-randomised clinical trial with 1 year follow up. The general practitioners are randomised into an intervention group and a control group. Participants automatically follow their general practitioner into the allocated group.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: August 16, 2019
• Study Start: March 27, 2019
• Primary Completion: October 1, 2022
• Study Completion: December 31, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)