Does Family Involvement in Patient Education Improve Hypertension Management A Single-Blind Randomized Parallel Group Controlled Trial
Does Family Involvement in Patient Education Improve Hypertension Management A Single-Blind Randomized Parallel Group Controlled Trial
To cite this article: Masumeh Hemmati Maslakpak, Behrooz Rezaei & Naser Parizad | (2018)
Does family involvement in patient education improve hypertension management? A single-
blind randomized, parallel group, controlled trial, Cogent Medicine, 5:1, 1537063, DOI:
10.1080/2331205X.2018.1537063
*Corresponding author: Naser Abstract: This study aimed to evaluate the effectiveness of family involvement in
Parizad, Urmia University of Medical
Sciences, Urmia, IR Iran patient education on hypertension (HTN) management. This single-blind rando-
E-mail: [email protected]
mized, parallel group controlled trial was conducted in Sayyed-Al Shohada hospital
Reviewing editor: in Urmia. One hundred participants who met inclusion criteria were selected by
Albert Lee, Centre for Health
Education and Health Promotion, convenience sampling and randomly allocated into control, patient-oriented,
The Chinese University of Hong
Kong, Hong Kong family-oriented and patient and family-oriented groups. Interactive educational
interventions were given to three intervention groups for four months. The control
Additional information is available at
the end of the article group received routine care. The Hill-Bone Compliance to High Blood Pressure
Therapy Scale and a mercury manometer were used to collect data. Data was
analyzed using SPSS V20. The results showed a significant difference in the mean
scores of the medical treatment compliance (primary outcome) and blood pressure
(BP) among four study groups after the intervention (p < 0.0001). Tukey’s test
revealed that medical treatment compliance significantly improved in the patient
and family-oriented group compared to other groups after the intervention
© 2018 The Author(s). This open access article is distributed under a Creative Commons
Attribution (CC-BY) 4.0 license.
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Subjects: Nursing; Nurse Education & Management; Nursing Research; Primary Care
Nursing
1. Introduction
Cardiac vascular diseases (CVDs) have been found to be the number one cause of death worldwide.
An estimated 17.7 million individuals died from CVDs in 2015, demonstrating 31% of all interna-
tional deaths (World Health Organization [WHO], 2017). Of these, complications of hypertension
(HTN) account for 9.4 million deaths worldwide every year (Lim et al., 2012). Of these deaths, an
estimated 7.4 million were due to coronary heart disease and 6.7 million were due to stroke (WHO,
2017). HTN is a worldwide epidemic (Stamler, 2013). Globally, around 20% of females and 24% of
males aged 18 and older had a raised blood pressure (BP) in 2015 (World Health Organization
[WHO], 2018). Having HTN is defined as blood pressure (BP) which exceeds of 140/90 mm Hg,
having a physician telling someone twice that they have HTN or if they take anti-hypertensive
medications (Roger et al., 2012). Further, because of weak health systems, the numbers of people
with HTN who are undiagnosed, untreated and uncontrolled are higher in low- and middle-income
countries compared to high-income countries (World Health Organization [WHO], 2013). HTN is
quite prevalent among the Iranian population (Aghaei Meybodi, Khashayar, Rezai Homami,
Heshmat, & Larijani, 2014). Estimation of the overall prevalence of HTN in those ages 30–55 of
the Iranian population was around 23% and 50%, respectively (Haghdoust, Sadeghirad, &
Rezazadeh, 2008). HTN was reported as the most significant risk factor for CVDs in an Iranian
population (Sarrafzadegan et al., 2011).
It is well known that lifestyle factors play a crucial role in the development of HTN and future
steps need to be taken to provide interventions that improve lifestyle factors in economically
developed and developing countries (Bromfield & Muntner, 2013). Several reports have documen-
ted the importance of lifestyle modifications (exercise, a diet rich in fruits and vegetables and low
in fat and sodium, weight control/reduction, restricting alcohol consumption, especially excessive
drinking) in the prevention and treatment of high BP (Baena et al., 2014; Khalesi, Irwin, & Sun,
2018; Weber et al., 2014). A clinical practice guideline by the American Society of Hypertension and
the International Society of Hypertension for the management of HTN recommend lifestyle
modification as an important and effective first-line treatment strategy (Weber et al., 2014). The
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current challenge to clinicians is implementing lifestyle changes in the context of routine medical
care (N. Huang & Duggan, 2008).
Patient education regarding medication compliance along with teaching healthy lifestyle beha-
viors is an effective tool for BP management in the hypertensive population (Hacihasanoğlu &
Gözüm, 2011). A wide range of different strategies and interventions have been used to support
the patients in adherence to treatment plans, although the results are not consistent (Bobrow
et al., 2014). Finding better ways of communicating with patients, such as actively listening to the
patient and including the patient in the decision-making process has been demonstrated to
effectively reduce patient anxiety, along with improving treatment adherence and lifestyle
changes (Cobos, Haskard-Zolnierek, & Howard, 2015). A possible strategy to improve HTN manage-
ment is an extensive education program for the public and people with HTN (Campbell & Sheldon,
2010). Effective change in behavior occurs when learners actively interact with the content to be
learned, with the teacher and with each other (MacKeracher, 2004). Group discussion allows for an
ideal level of interaction and improves communication skills (Meo, 2013). Westberg and Jason
(2004) cite several compelling reasons for using group discussion to promote learning. They believe
learners are more likely to learn from each other in a supportive, nonjudgmental environment. All
group members can both give and receive peer-oriented feedback and they can practice skills that
can be applied later in real-life situations (Westberg & Jason, 2004).
Enhancement of community-wide BP control rates and HTN prevention can only be achieved via
multilevel and multicomponent approaches that include families and many other community
organizations (Beato, 2004). Family-oriented patient education defines as involvement of family
members or significant others in education of patients and may be useful in the control of HTN
(Chobanian, 2003). Family members should be involved in training programs to understand and
identify the needs of patients and to comply with treatment plans and provide care support (Hinkle
& Cheever, 2015). Family involvement plays a significant role in HTN treatment, by encouraging the
acceptance of self-care practices such as proper diet, medication adherence and physical exercise.
Thus, it was considered as a facilitating agent of adherence to treatment (Barreto & Marcon, 2014).
Long-term BP control requires intervention that includes training and reminders about medication,
medical appointments and follow-up to support adherence and persistence on treatment (Bobrow
et al., 2014). This study primarily aimed to evaluate the effectiveness of interventions (small group
discussion) based on a healthy lifestyle on HTN management (medication adherence, low sodium
regimen adherence, medical appointments adherence and the overall treatment compliance) in
four groups (control, patient-oriented, family-oriented, patient and family-oriented groups). The
second objective of the study is to evaluate the effectiveness of interventions on the controlling of
systolic and diastolic BP in patients with HTN. Our hypothesis was that the interactive group
discussion might have an effect on patients’ scores on HTN management and systolic and diastolic
BP in three intervention groups.
2. Methods
2.2. Participants
Patients with HTN and their family member were considered as participants in this study. Patients
referring to the clinical-educational center of Sayyed-Al Shohada, were included in the trial if they
met the following criteria: (1) had a known history of HTN for at least a year, (2) aged between 18
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and 60 years, (3) had no underlying health problem such as a history of psychological disorders,
cognitive impairment, hearing problems, chronic kidney failure, or CVDs, and (4) both the patient
and the family member were literate and willing to cooperate in the study. Exclusion criteria
consisted of: (1) patients’ or family members’ failure to participate regularly in the educational
sessions, (2) unwillingness to participate further in the study, (3) having underlying health condi-
tions such as CVDs, cognitive impairment, hearing problems, psychological disorders and chronic
kidney failure and (4) having no family. After consulting with a statistician and considering the
findings of a similar study by Sadeghi et al (SBP = 154.43 ± 16.16 in the intervention group,
SBP = 152.62 ± 14.40 in the control group) the sample size was calculated at 100 participants
for four groups by using the Power Analysis Software. Considering the probability of attrition in the
study, 108 participants were recruited based on the convenience method and assessed for elig-
ibility. Eight participants were excluded due to not meeting the inclusion criteria or not willing to
participate in the study (Sadeghi, Mohseni, & Khanjani, 2014).
Primarily these 100 selected participants were invited to a meeting with researchers. All of them
were given informed consent to sign and participate in the study. At the introductory meeting, the
researchers introduced the objectives of the study and explained the steps involved in the research
process, and recorded participants’ telephone numbers. In the next step, 100 selected participants
were randomly allocated into 4 equal, 25-member groups: control group, patient-oriented group,
family-oriented group and patient and family-oriented group by using four different-colored
envelopes. Patient-oriented group included patients with HTN. Family-oriented group included
designated family members. Patient and family-oriented group included both patients and desig-
nated family members. The participants in the three interventional groups (patient-oriented,
family-oriented and patient and family-oriented groups) were invited to attend another meeting
to select an appropriate time for their interactive educational sessions (Figure 1).
Excluded (n = 8) , Not
meeting inclusion criteria
(n = 5), Declined to
participate (n =3), Other
reasons (n =0)
Analyzed (n= 25) Analyzed (n= 25) Analyzed (n= 25) Analyzed (n= 25)
Excluded from Excluded from Excluded from Excluded from
analysis (n=0) analysis (n=0) analysis (n=0) analysis (n=0)
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This scale has been validated in many investigations, one of which was in a South African
primary health care setting. Lambert et al. verified the criterion validity and internal consistency
of the Hill-Bone Scale; their results were compared favorably with those from an urban African-
American setting (Standardized Cronbach’s alpha was 0.74–0.84) (Lambert, Steyn, Stender,
Everage, & Fourie, 2006). In Iran, Taher et al. confirmed the validity of the scale based on the
content validity approach and under the supervision of 12 faculty members at the Shahid Beheshti
School of Nursing. Moreover, the reliability of the scale was confirmed by calculating the
Cronbach’s alpha coefficient of the scores of 20 patients with HTN; the alpha was found to be
0.80 (Taher, Abredari, Karimy, Abedi, & Shamsizadeh, 2014). In the present study, the content
validity of the scale was verified by 10 nursing faculty members and 5 cardiovascular specialists,
and the reliability of the instrument was calculated to be 0.87, 0.94, 0.79, 0.88, respectively for
total treatment, medication, low sodium regimen and medical appointments adherence using
Cronbach’s alpha.
2.5. Procedure
The content of group discussion was about eating healthy food and decreasing the salt in the diet,
maintaining a healthy weight, increasing physical activity, managing stress, quitting smoking,
monitoring BP at home, adhering medical appointments and adhering medication regime. In this
study, the same educational content was used to educate the three interventional groups. The
participants in the patient-oriented, family-oriented and patient and family-oriented groups, were
subsequently scheduled to attend the educational classes held at the clinical-educational center of
Sayyed-Al Shohada in Urmia.
After consulting with the cardiologist and considering educational content volume, the
research team decided to hold 48 training sessions during the following 4 months. After
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conferring with the participants, the classes were scheduled as follows: The classes were held
four times a week in the first month. They were held three times a week in the second and
third month and twice a week in the fourth month. These interactive educational classes were
held between 8 A.M. and 2 P.M. during working days. Patients and their designated family
members in family-oriented and patient and family-oriented groups (one fixed member for
each patient) chose an appropriate time according to their convenience. These classes lasted
around 50 minutes. In each 50 min session, in addition to group discussion, a combination of
didactic methods such as a short lecture, eliciting experience of individual participants, small
group work, experiential exercises and individual work is also used. The last session included
action planning by writing a “‘letter to oneself’”, which every participant received 4 months
after education. Didactic materials included overhead transparencies, flip charts, handouts
and worksheets. The aims of this program included providing information regarding lifestyle
and health, initiating self-reflection on healthy lifestyles, changing attitudes, enhancing posi-
tive emotions regarding lifestyle changes and encouraging action planning. All interactive
educational group discussions were led by three researchers who had been trained and
coordinated by a research group leader before the intervention. They had also involved in
developing the intervention and used peer supervision for any difficulties while conducting the
intervention.
To assure the treatment integrity, samples from all courses at each site were observed by
external judges using a structured observational sheet. It contained a checklist regarding contents,
the didactic methods sequence, and duration of each of the sessions as well as the proportion of
patients participating actively. These checks confirmed that the intervention was delivered as
prescribed by the manual. It showed that the majority of the participants was actively taking
part during a session. The participants in the control group were given routine education. The
control group received the paper-based educational materials and all participants completed the
Hill-Bone Scale and their BP was measured six times at the end of the intervention.
3. Results
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Age Mean)SD) 53.20 ± 10.05 51.88 ± 8.58 54.28 ± 8.82 49.96 ± 8.27 p = 0.363 ***
BMI(SD) 24.77 ± 2.9 24.92 ± 3.18 24.10 ± 2.1 24.64 ± 3.03 p = 0.104 ***
Disease duration Mean)SD) 5.33 ± 1.66 5.67 ± 2.89 5.26 ± 1.47 5.62 ± 1.11 p = 0.322 ***
(7.48 ± 1.12), family-oriented group (4.68 ± 1.18), patient-oriented group (5.24 ± 1.16) and patient
and family-oriented group (3.80 ± 0.81) (p < 0.0001). With regard to the medical appointments
adherence scores, the results of the ANOVA indicated no significant differences among the four
study groups in the pre-intervention period (p = 0.608). Nevertheless, there were significant
differences among the four groups’ mean medical appointments adherence scores after the
intervention (control group: 5.16 ± 0.80, family-oriented group: 3.12 ± 0.88, patient-oriented
group: 3.80 ± 0.81 and patient and family-oriented group: 3.48 ± 0.71; p < 0.0001). No significant
differences were observed among the four groups in mean scores of the overall treatment
compliance before the intervention. However, a significant difference was observed in mean the
overall treatment compliance scores of (control group: 34.36 ± 2.78, family-oriented group:
21.24 ± 3.62, patient-oriented group: 25.68 ± 3.59 and patient and family-oriented
group:19.46 ± 2.73) (ES = 1.8, p < 0.0001,) (Table 2).
Tukey’s test revealed that medication adherence (p < 0.0001), low sodium regimen adherence
(p < 0.0001), medical appointments adherence (p < 0.019) and treatment compliance (p < 0.0001)
significantly improved in the patient and family-oriented group compared to other groups after the
intervention (Table 4).
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Table 2. Comparison of treatment compliance and its domains among the four groups at the
beginning and at the end of the study
Variable Control group Family- Patient- Patient-and- p Value
oriented group oriented group family- ANOVA
oriented group
Table 3. Comparison of systolic and DBP among the four groups at the beginning and at the
end of the study
Variable Control group Family- Patient- Patient-and- ANOVA
(Mean ± SD) oriented group oriented group family-
(Mean ± SD) (Mean ± SD) oriented group
(Mean ± SD)
(SBP) Pre-intervention 13.28± 152.48 143.08 ± 11.01 8.83 ± 147.32 14.18± 146.80 73. F = 7
062.0 = p
Post- 154.68 ± 13.27 138.08± 9.70 140.00± 9.12 138.40± 11.43 03. F = 24
intervention p < 0.0001
Pre minus post −2.20± 2.06 5.00± 4.53 7.32± 2.54 8.40± 6.11 36. F = 60
p < 0.0001
(DBP) Pre-intervention 85.48± 7.51 81.48± 9.93 88.32± 6.83 83.96± 10.24 71. F = 7
0.057 = p
Post- 86.88± 8.00 76.64± 9.63 79.60± 6.75 75.20± 8.35 14. F = 22
intervention p < 0.0001
Pre minus post −1.40± 2.12 4.84± 2.77 8.72± 6.20 8.76± 6.20 82. F = 56
p < 0.0001
4. Discussion
Study results were discussed in three separate sections: first, interactive group discussions had a
significant affect on treatment compliance (medication, low sodium regimen and medical appoint-
ments adherence) of patients with HTN. Second, the affect of interactive educational intervention
on medical treatment compliance was more significant in patients and family-oriented group
compared to others. Third, family-oriented patient education resulted in improving BP control
and ultimately reduced systolic and DBP in patients with HTN.
In line with our results previous studies have confirmed that educational interventions improved
patients’ knowledge about their disease, general comprehension of medications and their beliefs
about medicines and ultimately would increase their active participation in treatment (Magadza,
Radloff, & Srinivas, 2009; Rubin, 2005). Similar to our findings, Kayima et al. mentioned one of the
ways to improve treatment compliance in patients with high BP is to educate patients (Kayima,
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Table 4. Pairwise comparison of self-care and its domains among the four groups at the
beginning and at the end of the study
Variable Groups Control Patient- Patient-and- Family-
oriented family- oriented
oriented
Medication Family-oriented p < 0.0001 p = 0.476 p < 0.0001 –
adherence
Patient-oriented p < 0.0001 – p < 0.0001 p = 0.476
Patient-and-family- p < 0.0001 p < 0.0001 – p < 0.0001
oriented
Control group – p < 0.0001 p < 0.0001 p < 0.0001
Low sodium Family-oriented p < 0.0001 p = 0.025 p = 265 –
regimen
Patient-oriented p < 0.0001 – p < 0.0001 p = 0.025
adherence
Patient-and-family- p < 0.0001 p < 0.0001 –
oriented
Control group – p < 0.0001 p < 0.0001 p < 0.0001
Medical Family-oriented p < 0.0001 p = 0.394 p = 0.019 –
appointments
Patient-oriented p < 0.0001 – p = 0.499 p = 0.394
adherence
Patient-and-family- p < 0.0001 p = 0.499 – p = 0.019
oriented
Control group – p < 0.0001 p < 0.0001 p < 0.0001
Treatment Family-oriented p < 0.0001 p = 0.298 p < 0.0001 –
compliance
Patient-oriented p < 0.0001 – p = 0.001 p = 0.298
Patient-and-family- p = 0.007 p = 0.001 – p < 0.0001
oriented
Control group -– p < 0.0001 p = 0.007 p < 0.0001
(SBP) Family-oriented p < 0.0001 p = 1.000 p = 0.926 –
Patient-oriented p < 0.0001 – p = 0.956 p = 1.000
Patient-and-family- p < 0.0001 p = 0.956 – p = 0.926
oriented
Control group – p < 0.0001 p < 0.0001 p < 0.0001
(DBP) Family-oriented p < 0.0001 p = 0.926 p = 0.585 –
Patient-oriented p < 0.0001 – p = 0.241 p = 0.926
Patient-and-family- p = 0.013 p = 0.241 – p = 0.585
oriented
Control group – p < 0.0001 p = 0.013 p < 0.0001
*Tukey’s test
Wanyenze, Katamba, Leontsini, & Nuwaha, 2013). Through patient education, all misunderstand-
ings that patients have about their treatment can be explained. This can improve patients’
adherence to treatment (Saounatsou et al., 2001) and may then possibly lead to improved BP
control (Gwadry-Sridhar et al., 2013; Park et al., 2011).
The results also showed that patients’ treatment compliance has promoted more in the patient
and family-oriented group compared to other intervention groups. Consistent with our findings, a
study result indicated that poor family support along with other factors as causes of poor treat-
ment compliance among patients with HTN (Olowookere et al., 2015). Shen et al. revealed that the
family member-based educational intervention has positive effects on patients’ adherence to BP
monitoring and hypertensive medications (Shen et al., 2017). Implementing of a family member-
based management in patients with HTN in rural China shows satisfactory effects with respect to
improved treatment compliance and BP control (S. Huang, Chen, Zhou, & Wang, 2014). Thus, family
caregivers need information and training to ensure that patients’ needs are met and this requires
developing patient/family education materials and training programs (Houts, Nezu, Nezu, &
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Bucher, 1996). A systematic review reported that interventions including patients and families
education through individual and group discussion improved patients’ knowledge of medications,
anti-hypertensive therapy and BP control (Gwadry-Sridhar et al., 2013). Similar to our findings, the
positive effect of family-based education on appointment-keeping behavior, BP monitoring in
patients with HTN has been confirmed in an earlier study (Morisky, DeMuth, Field-Fass, Green, &
Levine, 1985). Barreto and Marcon reported that the family facilitates patients’ adherence to
treatment. Patients perceive the family as a safety, sympathetic and supportive sources. Thus,
recognizing the strengths and weaknesses of patients’ families can help nurses to adopt proper
strategies in their care in a therapeutic process (Barreto & Marcon, 2014). Miller et al. confirmed
that family support had an important impact on treatment adherence in patients with chronic
diseases. They also, reported that non-adherence to medical treatment increased in patients,
when there were no family members involved in patient education and daily care (Miller &
DiMatteo, 2013).
In this study, interactive educational group discussions in all intervention groups (family-oriented,
patient-oriented and patient and family-oriented groups) led to decreased systolic and diastolic BP in
patients. Talking to patients and their families about changing lifestyle and encouraging them to
have a healthy lifestyle, exercising appropriately for their age, consuming proper nutrition with a low
salt diet was an effective step in reducing BP. An experimental evidence has suggested that support
from family can help patients take their anti-hypertensive medications correctly and their systolic or
diastolic BP were decreased significantly after 6 months intervention (Shen et al., 2017). Consistent
with our result, Morisky et al. revealed that the family member support educational program had
significant effects on decreasing in DBP variability (Morisky et al., 1985). A recent study in Iran,
investigated the effects of group discussion with mail high school students on their parents’ lifestyle
and HTN control showed positive effects of the intervention on patients regarding controlling HTN,
decreasing BP, adhering to diet and anti-hypertensive medications (Ezzati, Anoosheh, &
Mohammadi, 2012). Implementation of the family-centered empowerment model for elderly people
with HTN has been associated with controlling and improving the BP (Keshvari, Hedayati, Moeini, &
Alhani, 2015). This fact can also be observed in the present study, as family involvement in patient
education was reported as facilitating BP management in patients with HTN.
Our study has several possible limitations. First, our study population was limited to a select group of
patients with HTN and their family members living in Urmia, and these patients may not represent all
other hypertensive patients. Second, our sample size calculated 100 patients for four groups that are
relatively low. Therefore, our study findings should be generalized to the clinical situation with caution.
Third, patients selected one family member to participate in educational sessions, and it is more likely
that family members participating in the groups were more supportive of patients than family
members not participating. There was also a possibility of confounding variables, including uncontrol-
lable variables, such as the psychomental characteristics and the cultural background of patients and
their families, as well as their motivation to learn that could affect their learning ability.
5. Conclusion
The results revealed that family involvement in patient education plays a significant role in HTN
management, by encouraging the patients to adhere to medication, low sodium diet and medical
appointments. The results also indicate that iteractive educational interventions based on a
healthy lifestyle with the patient or family are effective in increasing treatment compliance and
reducing systolic and diastolic BP. However, if education is held with the presence of both the
patient and the family, the greater effect on treatment compliance and BP control will be
observed.
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and mandate family-oriented education in the routine nursing care and clinical services in order to
promote HTN management. It ultimately reduces the medical cost for both patients and health-
care systems.
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