International Journal of Cardiovascular ResearchISSN: 2324-8602

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Research Article, Int J Cardiovas Res Vol: 6 Issue: 1

Possibilities for Patients with Elevated Blood Pressure to Achieve Blood Pressure Control without Affecting Quality of Life (the PEQ study): A Study Protocol

Eva Drevenhorn*, Helena Rosén, Rebecca Gagnemo Persson and Eva I Persson
Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden
Corresponding Author : Eva Drevenhorn
Department of Health Sciences, Faculty of Medicine, Lund University, Box 157, SE-221 00 Lund, Sweden
Tel: +46 46 222 19 28
E-mail: [email protected]
Received: November 02, 2016 Accepted: December 21, 2016 Published: January 09, 2017
Citation: Drevenhorn E, Rosén H, Persson RG, Persson EI (2017) Possibilities for Patients with Elevated Blood Pressure to Achieve Blood Pressure Control without Affecting Quality of Life (the PEQ study): A Study Protocol. Int J Cardiovasc Res 6:1. doi: 10.4172/2324-8602.1000299

Abstract

Several interventions on adherence have been tested in hypertension care but still the number of patients with well controlled blood pressure is not increasing. The aim is to get a deeper understanding of the patients’ reasons for not following their treatment as a base for in collaboration with the patients, developing effective interventions. A mixed methods design is to be used. Patients with hypertension who have considered changing lifestyle will be interviewed individually about their reasons for changing or not changing lifestyle and for taking or not taking medicines. Other patients, both those who do and those who do not have well-controlled blood pressure, treated at health centres and hospital clinics, will be asked to fill in instruments. The Exercise of Self Care Agency instrument gives information about the patients’ ability to perform self-care (change lifestyle) and the SF-36 is about health-related quality of life. Finally, patients will be asked to participate in focus-group interviews about how they want to be treated and what would be of help for them to achieve blood pressure control. From the findings we will create intervention/interventions without negative impact on quality of life together with the patients. These interventions are to be carried out and evaluated in real practice with patients with hypertension and other significant persons or health care personnel that may be involved.

Keywords: Hypertension; Patient adherence; Quality of life; Primary care

Keywords

Hypertension; Patient adherence; Quality of life; Primary care

Background

According to WHO, the global prevalence of raised blood pressure in adults from the age 18 was in 2014 approximately 22% [1] which means that about 1-1.5 billion individuals are affected. Worldwide there is a higher prevalence of elevated blood pressure in men than in women (ibid). Individuals with hypertension have been shown to have poorer health related quality of life (HRQoL) than normotensive individuals [2] and also, elevated blood pressure is known to increase the risk for cardiovascular morbidity and mortality due to coronary heart disease and ischemic and/or hemorrhagic stroke.
In Sweden, 24% of the male population is diagnosed with hypertension, the percentage of women diagnosed with hypertension was in 2014 14.5 [1]. Only about 20 to 30 % of the Swedish patients with hypertension have their blood pressure under control i.e. <140/90 mmHg [3] and the most important factor to uncontrolled blood pressure is non-adherence to treatment. A number of reasons to nonadherence have been reported. Some patients mention different life events as a reason to non-adherence while others report difficulties with their pharmaceutical treatment like side effects, complexity of drug regimens and an impact on daily life [4]. The use of generic drugs may also have an implication on patients perception and adherence to prescribed medication [5] as well as the costs of medication [4]. Also the impact of low health literacy may be considered [6] as a reason for non-adherence. Health literacy is defined by the WHO as meaning “the cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health”.
First line treatment for patients with moderately elevated blood pressure is change of lifestyle with or without the combination of pharmacological treatment [7]. Lifestyle modifications or change include cessation of smoking, reducing the intake of alcohol, body weight reduction, diet and physical activity as well as stress management [3].
Theoretical framework of self-care
Treating hypertension involves change of lifestyle and medication which could be expressed as engaging in self-care. In Orem’s nursing theory of self-care [8] it is presupposed that people through exercising intellectual and practical skills maintain to take daily care of themselves. When it comes to changing life situations people’s different preferences affect their choices. An individual who is challenged but lacking the ability to perform a lifestyle change for health reasons, is said to have a self-care deficit. On the contrary, if the individual performs the lifestyle change the person has exercised one’s agency in practising self-care. The individual patients have to attend to their treatment themselves, but the health care personnel can be of great support. In Orem’s theory, the nursing actions are integrated and they are, in this case, composed of health educative actions. These actions involves to educate, guide and support the patient to take responsibility for their own self-care.

Aims and Research Questions

The purpose of the study is to get an understanding about what problems patients with hypertension are facing, how they manage these challenges, how they feel and what requirements they believe are important to have in their treatment. These factors will later act as a foundation and incentive for designing an intervention that may result in increast number of patients achieving blood pressure control with maintained quality of life.
Specific research questions are:
1. For what reasons do or do not patients change lifestyle as well as take their medicines to treat their hypertension?
2. How is the patient’s view on ability to perform self-care, in this context, to change lifestyle whether blood pressure control is achieved or not?
3. How is quality of life affected when patients do or do not achieve blood pressure control?
4. What do the patients with hypertension want and expect in the encounter with the health care personnel?
5. Besides contact with the health care, what else would be helpful for the patients to achieve blood pressure control?
6. How do age, gender, cultural and psychosocial aspects affect the patients’ ability to achieve blood pressure control?

Methods

The study is initially an explorative multicenter study where interviews and questionnaires will be used for data collection. The descriptive results will later act as a foundation and incentive for designing an intervention study.
Study population and settings
Inclusion criteria are patients >20 years of age diagnosed with hypertension and being able to read and speak Swedish. They should have been diagnosed ≥ 9 months ago to have had the opportunity to have evaluated any lifestyle change and/or medication. Patients having another treatment goal than ≤ 140/90 mmHg is an exclusion criterium. To fill in questionnaires 300 patients who have achieved blood pressure control (≤ 140/90 mmHg) and 300 patients who have not (>140/90 mmHg) are to be recruited, totally n=600. Another 25 patients with hypertension are to be recruited for the individual interviews. These patients should have considered changing lifestyle regarding one or more of the areas of tobacco, alcohol, diet, physical activity or stress. Yet another 32 patients will be recruited to take part in focus group interviews (Figure 1).
Figure 1: Overview of study participants and data collection in the different studies.
To preserve that the study population will be representative for the region of Skåne, Sweden, we will use stratified sampling. Lists of the medical clinics at hospitals and health centres in the primary care will be made according to where they are placed geographically. Most patients in Sweden are followed up in primary care and just patients in need of specialist care are attending clinics at hospitals. For that reason we are to make sure that only one fifth of the patients (n=60) are recruted from specialist clinics and the rest (n=240) are recruted from health centres. We have applied for and received approval to conduct the study from the heads at organisational level both at hospitals in the region as well as from both public and privately managed health centres in the primary care. While the clinics and health centres are asked to participate in the study the controller of the study will see to that the number of patients they are asked to include in the study is according to the stratification plan. The stratification will also include age and gender and the patients are to be consequtively included.
Sample size and power calculation
Our statistical analyses concern data from the instruments Medical Outcome Study Short Form 36 (SF-36) [9] about health related quality of life and Exercise of Self Care Agency (ESCA) [10]. A study using the SF-36 instrument on a Swedish population with patients having hypertension [11] showed a SD of 26. That result was used as a base for a power analysis, which revealed that 300 patients in each group is needed to be able to detect a true difference in mean between the groups of SD ± 5.270 with the power of 0.8 to set a significance level of 5%. Should the groups instead be of 200 patients in each group the SD would increase to ± 6.459.
Another power analysis was made based on the ESCA instrument [10]. A Swedish study [12] on patients with hypertension showed a SD of 17.3 and this was used as a base for calculating that 200 patients were needed in each group to be able to dectect a mean difference of ± 4.859 with the power of 0.8 to set a significance level of 5%. Therefore we plan to include 300 patients in each group to protect the mean difference between the groups regarding the SF-36 instrument.
Assessments
To meet the aim and research questions we have chosen mixed method as research design [13]. This means that individual interviews and focusgroup interviews, and diverse kind of questionnaires will be used.
Individual interviews will be performed in order to answer research question one i.e. to find out for what reasons patients do or do not change lifestyle as well as take their drugs to treat their hypertension. The patients included should have considered changing lifestyle regarding one or more of the areas of tobacco, alcohol, diet, physical activity or stress.
To answer the research question two about the patient’s view on ability to perform self-care, the validated (ESCA) instrument [10] will be used. The instrument measures the degree to which persons perceive being responsible for self-care, motivation for their own care, knowledge to implement self-care, and self-worth that affect selfesteem and make health priorities. The instrument has 43 items and and is scored on a 5 point Likert- scale where responses range from 4, for “very characteristic of me” to 0 for “very uncharacteristic of me”. Eleven items are negatively worded and are reverse coded. Lowest score in the ESCA scale is 0 and the highest is 172 for the opportunity to practice self-care agency.
The ESCA instrument has been used in many health-related studies around the world [12,14]. The Swedish version has shown Cronbachs’ alpha of 0.78 [14].
The third research question regarding how quality of life is affected for this group of patients will be explored by patients who have achieved blood pressure control (≤ 140/90 mmHg) and patients who have not (>140/90 mmHg) will be asked to fill in the validated SF- 36 instrument [15]. The SF-36 is a widely used generic questionnaire and measures 8 different health domains; physical function, role limitations due to physical problems, bodily pain, general health, vitality, social function, role limitations due to emotional problems and mental health. According to standardized procedures subscales are computed and range from 0 to 100; higher scores indicate a better HRQoL. It is useful in comparing general and specific populations, and also in comparing the relative burden of disease and differentiating the health benefits of a wide range of different treatments. Therefore, a reference sample regarding age and gender matches to our sample will be randomly drawn from the Swedish SF-36 national normative database [15].
To answer the research questions four, five and six about what the patients want and expect in the encunter with health care personnel, what other things outside the health care area would be helpful for the patient and how age, gender, cultural and psychosocial aspects affect the ability to achieve blood pressure control, focus-group interviews will be performed. Focus-group interviews is a suitable method when observing synergy effects created by the group interaction. Further, focus group interviews to identify hidden patterns of thinking that may not be consciously apparent to the individual participant, but only noticed in discussions involving group dynamics, reveals the underlying layers of thoughts [16].
Data collection
When recruiting patients and collecting data on the stratified selected clinics and health centres, the heads will be asked to recommend a person in the staff group who can act as an agent for the research team to contact. That person will be visited by one of the researchers to receive information about the study. The agent will also get a file with study information, inclusion and exclusion criteria, the number of stratified patients to be included, how to code the included patients, questionnaires to be given to included patients and forms for written consent from the included patients. The agents will be responsible to collect and send in the filled in forms. The agents at the research centres are also asked to recruite patients for the individual interviews as well as the foucus group interviews according to the inclusion criteria for these patients.
One of the members in the research team will perform the individual interviews. The patients will be offered to determine place and time for the interview. After informed consent is repeated the interview will start with collection of the patients’ demographic data. The interviews will then be semistructured using an interview guide with one open question that will be asked to all included patients. The guide will also contain areas to be covered in the interviews with follow-up questions where patients are asked to provide deeper descriptions of their experiences. The interviews are estimated to take about 45-75 minutes each.
The focus-group interviews will be performed with 32 patients divided into four groups. The patients are invited to take part in the interviews at the research team’s working place. After repeated informed written consent the interview will start with one open question asked by one of the member in the research team acting as a group leader [16]. An interview guide will be used so as to secure that all aspects of the research questions will be covered with followup questions to clarify the patients views. Another member of the research team will observe the group interview and take notes. After the foucus group interviews the researchers will reflect over the content and interaction during the sessions. A warm or cold beverage will be served as to make the participants feel at ease. The interviews are estimated to last for about 1-1.5 hour each.
Both the individual and focus-group interviews will be recorded using a voice recorder and then transcribed verbatim.
Statistical analysis/qualitative analysis
Data from the SF-36 and the ESCA instrument will be analyzed using non-parametric statistical methods. In comparing groups Kruskal-Wallis’ and Mann-Whitney U-tests will be used. Onesample t test will be used to compare the SF-36 subscale total scores for the patients with blood pressure ≤140/90 mmHg and for those with >140/90 mmHg with a population norm. All statistical analyses will be performed by the use of Statistical Package for Social Sciences (SPSS) 17.0.
The transcribed interviews, both the individual and group interviews, will be analysed according to qualitative content analysis [17] using the computer program NVivo 10.0. The text is going to be both manifest and latent analysed to find trends and patterns of what the patients say when answering our research questions.

Ethics

As we are to interview people with hypertension and ask them to fill in questionnaires we are proposing an ethical dilemma as we ask people to reveal personal views and feelings. This ethical problem should be related to the importance of getting knowledge of the patients’ possibilities to make themselves heard and involved in creating a base for how to be treated by the health care personnel. An increased adherence to hypertension treatment is valuable both for human and for community economic reasons. The patients are asked to participate after they have got both written and oral information about the study. They are informed about that their participation is voluntary and that they can interrupt their participation at any time without any explanation and withdrawal will not imply any further consequences for the patient. The questionnaires and interviews will be numbered and the coding lists, the transcribed interviews and all the recordings will be locked up in a safe place and only the researchers involved will have access to them. When publishing the study results the data will be presented so that no individual person could be identified. All the material will be stored safely during 10 years and then destroyed. The project was approved by the regional ethical review board in Lund, Sweden (Dnr 2014/330).

Discussion

Globaly, raised blood pressure is one of the leading risk factor for mortality and is estimated to have caused 9.4 million deaths [18]. In order to achieve blood pressure control a comprehensive set of interventions is required. Several barriers for achieving blood pressure control have been identified. In low-income countries with a less developed primary health care system the main problem seems to be factors like lack of equipment, lack of health care personnel and poorly developed health care system. In Sweden, a high income contry, the health care system is well developed and yet only 20-30 % of the patients diagnosed with hypertension succeed in achieving blood pressure control. For health care professionals, a continuous improvement of clinical care quality is a core issue and one key question when trying to assist a person in achieving blood pressure control is why the patients are not adherent to the suggested treatment. Another question that arises is what the patient expects and needs from the health care personnel to be able to be adherent to the treatment.
A number of different interventions have been tested in hypertension care with the aim of increasing patients’ adherence to treatment to achieve a greater blood pressure control according to a Cochrane review [19]. These studies report some effect but despite this the number of well controlled patients do not increase. As the strategies hitherto has not have had the wanted effect we believe that another approach has to be taken. To our knowledge no studies are published where the patients are asked about what they would like to have in the care of them. When interviewing the patients individually we believe that we will get a deeper understanding of the reasons for not following ones’ treatment. Data from these interviews can then be used in the focus group interviews to reflect upon besides the other research questions we have about what the patients need and wish for their treatment.
We have choosen to use a mixed method design [13] so as to study the adherence problem from various perspectives as it is seen as a complex phenomenon. The patiens are to be interviewed individually to feel free to speak about individual experiences but also throgh the focus-group interviews be stimulated to form ideas about what would be helpful for them to have in their treatment. In answering the instruments about their self-care agency and perceived health related quality of life we will get yet another view on the problem to develop interventions together with the patients that are helpful for them.
The choice to study a population that is representative for the region, through stratified sampling, means that we preserve that all groups of people are represented. This is important as we want the future interventions to fit people with diverse needs. Some persons may be less able to understand or integrate strategies needed for adherence and of that reason also these persons must be included to make their voices heard. A limitation is the risk that we will not reach some unpriviliged persons i.g. immigrants as we have stipulated that the participants should be able to read and talk Swedish. To include these persons is something that we have to have in mind for future studies.

Relevance to Clinical Practice

The results from the explorative studies are intended to enhance awareness regarding issues faced by the individual patient diagnosed with hypertension. From these findings we will create an intervention/ interventions to help patients with hypertension to achieve blood pressure control without negative impact on percieved quality of life. These person-centred interventions might concern patient education in groups, involve patient associations in supporting the patients, counseling training for health care personnel, technical support or other factors or areas that the explorative studies reveal are appropriate. The future interventions are to be carried out and evaluated in real practice with patients with hypertension and other significant persons or health care personnel that may be involved. As the interventions probably will be of a complex nature the evaluation will be planned to secure a rigorous design [20].

Trial Registration

ClinicalTrials.gov NCT02682095

References

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