Aim
The aim is to evaluate the effect of using the YHF visual communication tool on changes in blood pressure and adherence to CVD preventive medications. Further, by means of questionnaires, the aim is to study whether changes in health-literacy, adherence, patient empowerment and risk communication are associated with changes in blood pressure, lipid levels and/or life style choices. By means of qualitative interviews, it will be investigated whether the use of the program heighten motivation, increases awareness of risk or creates unwarranted effects like causing the patients to be anxious.
Research question
Primary research question:
- Will the introduction of YHF during an annual blood pressure control consultation lead to improved general health literacy, improved medication adherence and empowerment after 12 months?
Secondary research questions:
- Will blood pressure be reduced among patients in the intervention group compared to the control group after 12 months?
- Will lower health literacy and/or low empowerment at baseline be associated with higher blood pressure at baseline?
- Will health literacy and/or empowerment be improved after 6 and/or 12 months among patients enrolled in the intervention group?
- Will increased health literacy and/or empowerment be associated with healthier lifestyle including diet, exercise and smoking habits after 12 months?
- Will there be subjective feelings of increased motivation or sickening after introducing the intervention?
- Will CVD risk be lower among patients in the intervention group compared to the control group after 12 months?
Clinical relevance
- Low medication adherence is a significant health, time and cost consuming challenge for patients with increased blood pressure as well as for their GPs.
- The study is not only relevant for the individual patient, but due to the very high prevalence of increased blood pressure, also of significant societal relevance.
- The study will address this clinically relevant challenge through improved risk communication and efforts to improve health literacy.
- Increased health literacy will most likely lead to fewer visits to the GP, better adherence, lower degree of complications, and thus, higher quality of life for the patient and fewer health costs for the society.
Trial Design
This study will use a mixed methods approach with a combination of a randomised controlled trial (RCT) and qualitative semi-structured interviews. The protocol has been developed using the SPIRIT checklist as guideline.
Participating general practices will be cluster randomized into two groups, an intervention and a control group. The randomization will be done by using REDCap’s randomization tool. Two general practices will function as pilot practices and be enrolled as if they were intervention practices. In these 2 practices patients will be assessed 3-6 months before the project practices. A subgroup Q, of 5-15 patients from the pilot group, will be selected for qualitative interviews.
GPs in the control group, will not be introduced to YHF and will follow their patients in the blood pressure control program as usual.
Study population
Participants
All general practices in the Region of Southern Denmark will receive a postally distributed, written invitation to an information meeting about the RCT. Practices not attending the meetings will in following inclusion rounds, be offered an introduction to the trial via video meetings. 30 GPs of those willing to participate, will, with due respect for geographical location and practice type, be representatively selected for participation.
Both incident and prevalent hypertensive patients will be included within an inclusion period of 6-12 months.
Sample size
Sample size calculation is based on blood pressure as primary outcome. For a two-sample pooled t test of a normal mean difference with a two-sided significance level of 0.05, a sample size of 120 participants per group is required. This is to obtain a power of at least 90%, to detect a difference of 5 mmHg between the means at baseline and after 1 year. To adjust for expected drop-outs, 30 participants will be added per group and at least 300 patients will be enrolled in the trial. To account for cluster-effects when randomising on practice level, the sample size will be further increased by 10-15% to reach 340 patients. More participants will be needed for subgroup analyses on sociodemographic and therefore, the aim is to reach a total of 600 participating patients. The pilot practices will provide information regarding the prevalence of patients with inadequately controlled blood pressure willing to participate, as well as more specific knowledge on the needed number of practices included, making the final sample size calculation uncertain at this point.
Randomisation
Participating GPs will be randomly divided in to two groups A and B, using the randomisation tool built in to REDCap. They will be given Trial General Practice Numbers (TGN) from A01-A15 (group A) and B01-B15 (group B).
Participants will be given Trial Participant Numbers (TPNs). TPNs will be generated by PREDICT (the software behind Your Heart Forecast) when patients are included and will be given consecutively starting from 0001. The number will be given a prefix A or B depending on which group (intervention or control) the participant’s general practice belongs to. Thus, the sequence of TPNs can vary in prefixes but will consist of unique 4-digit numbers (i.e. B0001, B0002, A0003, B0004, A0005, A0006, A0007… …). With this method of labelling TPNs and TGNs, there is room for adjustment if the number of participants/GPs ends up being either smaller or greater than the expected 640/32 in total.
Subgroup Q will be 5-15 participants chosen deliberately from the pilot group, to ensure it represents the intervention group for use in the qualitative interviews.
Inclusion criteria for general practices
- To ensure comparability to usual care, all the included general practices must use their own routine method to take blood samples, ECG etc., prior to annual blood pressure control consultations. All general practices in Denmark are supposed to follow a national quality guideline and take part in continuing education. This means that the standard routine methods vary only little across the country
- To ensure equal quality, all general practices must measure blood pressure using an ambulatory blood pressure device under standard conditions.
- To ensure comparability to usual care, inclusion and subsequent intervention must be in connection to a planned blood pressure control consultation, as part of the standard blood pressure control program (either at the time of diagnosis or as a planned annually control).
These criteria are controlled when the first author visits the practices in the start-up-faze (see chapter: “Practical procedures”).
Inclusion criteria for patients
- All patients must understand and read Danish and must be cognitively well functioning (be able to understand the trial information given, and thus make a decision on whether to participate on acceptable grounds).
- The patients must have Internet access, have 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 participate in blood pressure control consultations with 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.
- Males and females are included.
- Comorbidity is allowed with a few exceptions (see exclusion criteria).
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.
- 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:
a. Clinical symptoms of claudication
b. Diminished foot pulses
c. Carotid bruits
d. Radiological evidence of atherosclerotic arterial disease
e. Prior surgery /percutaneous interventions
- Prior stroke or mini-stroke (TIA).
- Angina, prior AMI or heart related operation.
Practical procedure
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 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).
Data collection:
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.
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.