Exclusion criteria for patients- 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.
- 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 of atherosclerotic arterial disease
- Prior surgery /percutaneous interventions
- Prior stroke or mini-stroke (TIA).
- Angina, prior AMI or heart related operation.
General practices will be actively involved in the RCT as follows (see trial flow chart—figure 1). All participating practices will receive a one-hour introduction to the project in their own clinic, conveyed by the first author, AEJ, and the staff members will at this time also receive relevant documents for further distribution to patients. At the introduction, the first author will assist the GP in drawing a list from the statistics module of their electronic patient journal. The list will show patients with the hypertension diagnoses K85, K86 and K87 and it will be sorted by CPR-number (central personal register) starting with 1st of January.
After identifying the list of patients from the statistics module, the practice will review the patients with regards to the inclusion/exclusion criteria. After exclusion, an invitational letter will be sent out to the first 25 of the remaining patients on the list. The invitation will contain a specific appointment for the patient, scheduled for the inclusion consultation with their GP. The invited patients can then opt out or show up at the appointment and receive the oral and written trial participant information. The inclusion consultation will be planned prior to the patients expected annual blood pressure consultation and will be planned so they can get blood samples taken at the same time. Thereby patients will not need to go to the practice more times than usual, but the practice will need to conduct an extra GP consultation to give trial information. The participating general practices will be compensated for their extra time spent on consultation with each trial participant and for the extra time spent on reviewing the patient list with regards to inclusion/exclusion criteriaThe practice will be compensated for this extra consultation.
A few days after the inclusion consultation, the participant will receive an email with a link to a questionnaire, which must be completed before the subsequent appointment with the GP. The first page of the questionnaire will be the informed consent form. If the patient answers no to the informed consent, further access to the questionnaire will be closed and the patient will be excluded from the trial.
The GP responsible for the following blood pressure control consultation will ensure that the questionnaire is filled out by the patient. GPs of the intervention group must subsequently guide their patient through YHF on their computer, uploading this individual patient´s data.
With the large number of patients with known hypertension and the compressed method of inclusion, it is expected that GPs will have enough use of the program Your Heart Forecast, to maintain the skills and knowledge to use the program, which they will be taught by the research group before start of the project.
The RCT will consist of a 12-month intervention period, except for participants in subgroup Q who will be interviewed 6 months after enrolment (t6) and subsequently excluded. Follow-up for all other patients will happen at the next annual blood pressure control consultation (t12) approximately 12 months after registration of baseline data (t0).
The intervention group will receive an educational e-mail, which also includes a reminder of the project and YHF, every 2 weeks. The first e-mail is sent out approximately 2 weeks after the initial blood pressure control consultation. The last e-mail is sent out 2 weeks prior to the expected 1 year follow up blood pressure control consultation. The e-mails’ health educational content will reflect available information from the Danish Heart Association’s web page (www.hjerteforeningen.dk).
The GPs are asked to make sure that blood pressures are measured as a standard ambulatory blood pressure just prior to the annual blood pressure control (t12).
Recruitment will take place from summer 2019 until the intended sample size is reached, presumably within 12 months. The RCT is expected to be completed during 2020.
Baseline data will be collected at recruitment, via the patient questionnaires and medical records.
The questionnaire (q1) will include questions to evaluate socioeconomic and sociodemographic variables, baseline health literacy, risk perception and self-efficacy (PAM–13[15]), smoking status, comorbidity and medication.
The second patient questionnaire (q2) is very short and will be sent out by email approximately 2 weeks after the first questionnaire and the informed consent has reached the research group. This questionnaire will focus on whether the patient was surprised about the risk score, if any changes in the medication were made and how the general experience of the YHF is. In this email, the intervention group will be informed that they have been selected to receive an email every second week with information about general health literacy, CVD risks and advice regarding risk reduction.
Six months after enrolment (t6) participants will be asked to answer the first questionnaire (q1) again.
Data regarding blood pressure will be obtained through questionnaires at baseline and after the first annual blood pressure control (t12), where blood pressure should also be measured as an ambulatory blood pressure. Data regarding number and content of contacts to the GP will be obtained from the patient´s medical records and the affiliated accounting system including prescription databases for estimating compliance. All telephone consultations, email consultations, clinic consultations and home visits are registered. Contacts from three years prior to the intervention and up until two years after, will be obtained.
Patients in the intervention group will receive their personal profile in the YHF to make it possible for them to access and use the program at home in between the blood pressure consultations at their GP. To gain access to their profile from home they shall use a personal link sent by email at the end of the blood pressure consultation with their GP. All data entered in YHF will be stored in accordance with Danish law by the software provider, with whom a data management agreement has been made.
Base-line measurements of health literacy, risk perception and PAM–13 will be used (in conjunction with socioeconomic and sociodemographic variables) to identify sub-groups of participants. Qualitative data will be obtained via semi-structured interviews, transcribed and analysed with systematic text condensation. The qualitative interviews will seek to shed light on possible explanations for the hypothesized effects on self-management, life style choices, blood pressure and contacts to the GP. If possible, the PhD student will personally make all interviews and transcriptions. In case of time constraints, an assistant will carry out part of the qualitative data collection and transcriptions.
Figure 1
(SPIRIT figure)
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STUDY PERIOD
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Enrolment
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Allocation
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Post-allocation
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Close-out
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TIMEPOINT
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3 months before inclusion
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1 week before inclusion
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Inclusion consultation
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1-2 days after inclusion consultation
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Annual Blood pressure consultation at GP
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1 week after BP consultation
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6 months after inclusion
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1 year follow up blood pressure consultation
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ENROLMENT:
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Eligibility screening
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X
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Randomization of general practices
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X
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Oral and written trial information
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X
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Informed consent
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X
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X
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X
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INTERVENTIONS:
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Questionnaire q1
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X
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X
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X
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Use of Your Heart Forecast
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X
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X
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Biweekly email follow ups
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Questionnaire q2
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X
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Interviews
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X
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ASSESSMENTS:
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Sociodemographic
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X
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X
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X
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PAM13
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X
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X
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X
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Height and weight
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X
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X
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X
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Blood pressure
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X
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X
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Lipid levels
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X
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X
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Experience of intervention
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X
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X
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User frequency of YHF
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X
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Number of contacts to GP before and during DANY
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X
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Outcome measures and statistical analysis:
For continuous outcomes, i.e. blood pressure and number of GP contacts, linear regression analysis of mean changes from baseline will be carried out. Ordinal regression and multinomial regression will be used for ordered and categorical outcomes i.e. PAM13 score. Adjustments for baseline values will be made. An intention-to-treat analysis will be applied. Subgroup analyses to identify groups that especially benefit from the intervention will be performed.
Since the authors oversee the project throughout and thereby have access to all data as it is generated, analyses on outcome measures will be carried out by a blinded statistician. Data will be delivered pseudonymised to the statistician.