Short summary

Since compliance is low with hypertension-patients in general practice, our objective is to evaluate the risk-assessment and risk-communication tool: "Your Heart Forecast" (YHF), to see if it can improve patient compliance, health literacy and empowerment.

We will conduct a cluster-randomised controlled trial and qualitative interviews.

We will investigate if the use of YHF can lower patients' blood pressure and increase their compliance, health literacy and empowerment.

We wish to conclude weather or not the use of YHF can improve the doctor-patient-relation and/or the compliance, and thereby open the discussion if YHF is a reasonable tool to implement in the national blood pressure control program.

Rationale

Compliance is generally low for most preventive treatments.

The present study will use an internet-based risk communication tool for patients with increased blood pressure with the aim of improving health literacy and treatment compliance, as well as reducing the blood pressure and the use of health care resources. 

The annual blood pressure control assessment represents a unique possibility for the general practitioner (GP) to motivate the patient for a healthier lifestyle and medical adherence. However, despite all good intentions, achieving blood pressure control in hypertensive patients is a big challenge. Almost 7 out of 10 Danish patients diagnosed with hypertension have inadequately controlled blood pressure, which is not only associated with a high risk of cardio vascular disease (CVD) but also with many contacts to the GP. As we know that intention to change is related to the perception of risk[2], the situation calls for new and more effective ways for GPs to communicate CVD risks and motivate patients for risk reducing strategies.

Your Heart Forecast is a health literacy and risk-communication tool, which communicates CVD risks as visual graphs. The basic idea is through improved patient-doctor interaction and communication to improve patient knowledge and understanding of CVD risk, and modifiability of risk. It is a tool that enables patients to participate in decision-making and possibly help motivate them towards healthy behaviour change. The program interactively guides the patient through the current predicted CVD risk, the predicted CVD risk compared to ideal risk factor control (the heart age), the risk as the patient gets older (the heart forecast), and finally the future risk if risk factors are altered. 

Description of the cohort

The trial participants will be found through the participating general practices which will all be situated in the region of Southern Denmark. We expect 600 participating patients.

Inclusion:

1. All included patients must be diagnosed with hypertension and participate in a standard blood pressure control program at their general practice.
2. Both patients with known hypertension and those newly discovered are accepted into the trial.
3. The inclusion and subsequent intervention will happen in connection to a planned blood pressure control consultation, as part of the standard blood pressure control program.
4. All patients must understand and read Danish and must be cognitively well functioning.
5. Age from 35 to 75 years (both included).
6. Both genders are included.
7. Comorbidity is allowed.
8. The patient must have Internet access, host an email address and read their emails on regular basis.
9. Patients must give informed consent prior to inclusion.

Exclusion:

1. 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.
2. If the patient during the trial, no longer fulfils inclusion criteria 4 and/or 8, they are excluded from the trial.
3. If the patient during the trial, develop prolonged illness so severe that treatment of hypertension is no longer a priority he/she will be excluded.

Data and biological material

Surveys:

We will ask for clinical data as height, weight etc. and we will ask for a variety of data regarding compliance, health literacy, sociodemographic and patient empowerment. Patient empowerment will be evaluated using Patient Activation Measure 13 (PAM13).

Data from patient files:

We will be looking at data on blood samples, prescriptions, type and number of consultations and reason for consultations.

Data from Your Heart Forecast:

We will look at the use of the program and compare to alterations in other data.

Collaborating researchers and departments

Research Unit of General Practice, IST, University of Southern Denmark

• PhD student Anders Elkær Jensen, MD
• Professor Jesper Bo Nielsen, Ph.D.
• Professor Jens Søndergaard, Ph.D., MD
• Associate Professor Niels Kristian Kjær, Ph.D., MD

Faculty of Medical and Health Sciences, University of Auckland, New Zealand

• Professor Rodney Jackson, Ph.D., MD

Publications associated with the project

Jensen, A.E., Søndergaard, J., Kjær, N.K. et al. 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 21, 11 (2020). https://doi.org/10.1186/s13063-019-3886-2