Danish Evaluation of Your Heart Forecast. A Study Among Danish General Practitioners and Patients in the Blood Pressure Control Program.
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Health literacy
研究概览
简要总结
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.
详细描述
The project description has been shortened to fit the format of clinicaltrials.gov.
Background:
To improve communication of risk messages, they must be communicated in a way that is understandable and relevant to the patient. Every individual is different and therefore communication tools must be personalised and easy to understand. This is important as low health literacy is present among close to half of the European population and is associated with poor health outcomes, low self-management and underestimation of personal Cardiovascular Disease (CVD) risk. Since the risk of CVD is the product of a complex combination of multiple individual risk factors, there is a need for communicating complex information in an easily understandable way. Several tools for calculating and communicating CVD risk have been developed, but rigorous testing of their communicative effects is lacking.
Inadequately controlled blood pressure is associated with an increased risk of CVD, and more frequent contacts with GPs. Intention to change behaviour is related to the patients' perception of risk. Consequently, better ways for GPs to communicate CVD risks and motivate patients for risk-reducing strategies are warranted. Efficient communication requires information to be presented in formats that encourage decision-makers, i.e. patients, to automatically extract specific meanings or overall messages. Use of graphical illustrations with distinct features has previously been shown to be an effective and user-friendly tool to communicate risk, especially to people with limited health literacy. A visual decision aid could be a way to improve the blood pressure consultations and to assure that GPs are supported to provide patients with the relevant information. It is suggested that using a decision aid will also systematise the consultation and make it more reproducible.
The present study will use the internet-based risk communication tool Your Heart Forecast (YHF) to evaluate, whether it can influence patients' understanding of risk and treatment adherence. This will be done paying special attention to patients' blood pressure, lipid levels, empowerment and health literacy. The rationale behind the tool is to help improve patient-doctor interaction and communication so that the patient can gain an improved understanding of his/her CVD risk, and the modifiability of risk. Patients with hypertension have been chosen as a case study since high blood pressure is one of the main modifiable risk factors for CVD, as opposed to i.e. age, gender, ethnicity and family history.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •Patients must give informed consent prior to inclusion.
- •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.
- •Comorbidity is allowed with a few exceptions (see exclusion criteria).
排除标准
- •If the patient during the trial, no longer fulfils inclusion criteria 1 and/or 2, they are excluded from the trial.
- •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.
- •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.
结局指标
主要结局
Health literacy
时间窗: Questionnaire sent out at inclusion, after 6 months and after 1 year
Self-reported change in health literacy through questionnaires.
次要结局
- Blood pressure(Calculated after the 1 year trial period)
- Empowerment(Questionnaire sent out at inclusion, after 6 months and after 1 year)
- Adherence(Questionnaire sent out at inclusion, after 6 months and after 1 year)
- Number of contacts(Counted after end of 1 year trial period.)
研究者
Anders Elkær Jensen
Medical doctor, Principal Investigator
University of Southern Denmark