The Outcomes of Home-Based Intervention to the Diabetics According to the Health Belief Model: A Randomized Controlled Trial
Phase: NA
Conditions: Diabetes Mellitus, Type 2, Home Visit
Sponsor: Dilay AÇIL,PhD

 
 
 
 
 
 
 
 
 
 
 
The Outcomes of Home-Based Intervention to the Diabetics According to the Health 
Belief Model: A Randomized Controlled Trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
14.07.2017 
 

BACKGROUND 
The prevalence of diabetes is steadily increasing around the world and patients are suffering 
the complications dramatically (International Diabetes Federation [IDF], 2015; TURDEP-II 
Study Group, Diabetes epidemic in Turkey, 2011). However, for patients with diabetes in the 
self-management education, the emphasis has been on conducting interventions by 
determining the beliefs of people with diabetes rather than eliminating the lack of knowledge 
on the issue (Harvey and Lawson 2009). 
Several qualitative studies on the issue have demonstrated that patients with diabetes are 
unable to establish a balance between their quality of life and medical outcomes associated 
with the disease, and thus they want to get timely support from medical experts and to 
understand their responsibility of self-management in line with their beliefs and perceptions 
(Açıl and Bahar 2017; Frost et al. 2014; Gazmararian et al. 2008). Therefore, it is assumed 
that nursing interventions based on theory (e.g. Health Belief Model [HBM] etc.) not only 
would benefit individuals but may also contribute to the production of new knowledge related 
to disease perception and behavior change (Champion and Skinner, 2008; Dalton, 2012). In 
studies conducted with patients with diabetes according to the HBM, the results of metabolic 
control and self-care efficacy have been proved to improve (Kartal ve Özsoy 2006; Olgun ve 
Altun 2012; Adejoh 2014; Mcelfish et al. 2016; Karimy et al. 2016; Wang et al. 2017). It has 
been determined that the benefit and severity of their illnesses perceived by patients with 
diabetes are significantly related to the management of diabetes, and that the perceived 
barrier, benefit, severity, and self-efficacy account for 20%-60% of health behaviors related to 
diabetes management (Adejoh 2014; Karimy et al. 2016; Wang et al. 2017). 
 Among the components of diabetes self-management are compliance with medication, 
medical nutrition therapy (MNT), physical activity, avoidance of smoking, and adequate and 
quality sleep (Handelsman et al. 2011). In addition, regular glucose, blood pressure, and lipid 
regulation controls have been shown to reduce acute and chronic complications of diabetes 
(Loveman, Rolye, Waugh 2009; Malanda et al. 2012; Alvarado et al. 2017). However, 
according to the US National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK), glucose, blood pressure, and lipid levels are at the recommended level only in 12% 
of individuals with diabetes. Applications aiming to develop diabetes self-management skills 
that start in the hospital with the diagnosis of diabetes should be turned into community-based 
disease management programs performed at home.  
In the literature, there are studies indicating that in patients with diabetes, home-care 
interventions are supported with the use of technology, and ensuring the provision of the 

continuity of care (Loandman, Rolye, Waugh 2009; Stone et al. 2010; Rosa et al. 2014).  In 
the Diabetes Prevention and Control Program launched in 2011 in Turkey, the promotion of 
quality of life was stated as one of the components of the program, and the necessity of 
maintaining home care services was emphasized (Turkey Ministry of Health Primary Health 
Services Directorate, 2011). The nurse should be able to define control problems experienced 
by a patient with diabetes and to plan appropriate nursing interventions (Sousa et al. 2005).  
Diabetes is also directly and indirectly associated with health expenditures due to its 
morbidity and mortality burden (Republic of  
Turkey Ministry of Health Primary Health Services Directorate, 2011). It is known 
that 12% of the world's healthcare expenditures (673 billion US dollars) are spent on diabetes 
and its complications. In Turkey, the average per capita expenditure on diabetes is 846 US 
dollars ([IDF], 2015). According to the data released by the Social Security Institution, about 
23% of the budget allocated for health in Turkey is spent on diabetes and its complications 
(https://www.tubitak.gov.tr/sites/default/files/1003-sab-ttip-2017-1.pdf 27.03.2017). Of the 
different public health interventions in Turkey, the one with the highest cost is the monitoring 
of diabetes (Republic of Turkey, Ministry of Health, Refik Saydam Hygiene Center 
Presidency, 2004). It has been emphasized that nurses specialized in primary health care can 
provide high quality care to individuals, improve their health-related outcomes and contribute 
to reduction in health expenditures (Bahia et al. 2011). 
According to the results of a qualitative study conducted within the Health Belief 
Model, there is a gap in the literature related to studies investigating individual-specific 
nursing interventions provided with home visits, and assessing the cost of the interventions. 
Therefore, it is thought that home care provided for individuals with diabetes in line with their 
perception of their illness will create a difference, and that nurses working in primary 
healthcare can develop strategies to monitor patients with diabetes. 
The aim of the present study is to determine the effects of home-based nursing 
interventions carried out according to the Health Belief Model on healthcare outcomes of 
patients with diabetes. 
 
 
 
 
 
 

STUDY PROTOCOL 
 
 
Type of the study 
The study was conducted as an intervention (randomized controlled, single blind) one. 
Location and Time of the Study   
The study was carried out between January 2015 and March 2017 in three districts of 
İzmir, a province in the western part of Turkey. 
The study population and sample       
While the patients with diabetes living in districts comprised the study population, the 
sample was selected from patients with type II diabetes registered to Family Health Centers.  
According to the Consolidated Standards of Reporting Trials (CONSORT) 
recommended for randomized controlled studies, a randomization flow chart was established 
(Figure 1), and 2460 people with diabetes were assessed for compliance with diabetes (Schulz 
et al. 2010; Sunay et al. 2013). From the 1081 people with diabetes who met the inclusion 
criteria, the intervention and control groups each to include 65 individuals were constructed 
using the "Research Randomizer" computer program.  The study was completed with 81 
people with diabetes (42 in the intervention group and 39 in the control group). Post hoc 
power analysis was performed using the G-Power Data Analysis program and the power of 
the study was determined as 100% at the 95% confidence interval and p = .05 significance 
level.  
The participants were not told to which group they were assigned. Thus, the study was 
conducted as a single-blind study.  
Inclusion Criteria:  
Volunteering to participate in the study 
Having Type 2 diabetes 
Not having diabetes-related complications  
Having a mobile phone to contact any time 
 
Data Collection Tools 
Data Collection Form for patients with Diabetes  
This form includes questions about the sociodemographic and disease-related 
characteristics of patients with diabetes. 
 

Metabolic Control Data Form  
The form developed by the researcher in line with the literature was used to compare 
patients' diabetic control metabolic evaluations and to compare pre- and post-intervention 
values in the study process (fasting plasma glucose level, postprandial level, HbA1c, BMI, 
blood pressure, frequency of complication-related hospital admissions).The cost was 
calculated by comparing the intervention and control groups in terms of the frequency of their 
hospital admissions. To calculate the cost of hospitalization for each patient, consumables 
(blood glucose measuring equipment, wound care products, wound cover, sterile gloves, 
catheter, urine bag, pen needle, infusion pump set) and time spent by the nurse (30 minutes 
for each patient) were determined. The prices of the consumables were based on the Health 
Practice 
Communiqué 
published 
on 
March 
25, 
2017 
(http://www.resmigazete.gov.tr/main.aspx?home=http://www.resmigazete.gov.tr/eskiler/2017
/03/20170325.htm&main=http://www.resmigazete.gov.tr/eskiler/2017/03/20170325.htm ET. 
22.04.2017). The cost of the time spent by the nurse was based on a new graduate nurse's 
salary and was calculated by using the formula '' salary / working time of May 2017 x 0.5 
hours''. 
 
Health Belief Model Scale in Patients with Diabetes  
The scale was developed in China, the validity and reliability study of the Turkish 
version of the scale was conducted by Kartal and Özsoy (2007). The Cronbach’s alpha value 
was 0.72 and 0.90 respectively (Tan, 2004; Kartal and Özsoy 2007). The subscales of the 
scale were as follows: perceived susceptibility, perceived severity, perceived benefits, 
perceived barriers and recommended health behaviors. In the present study, the Cronbach’s 
alpha value was 0.72. 
 
Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes 
The scale was developed in 1999, the validity and reliability study of the Turkish 
version of the scale was conducted by Usta (2001). The Cronbach’s alpha value was 0.89 for 
both versions (Van Der Bijl et al. 1999; Usta 2001).The scale has 4 subscales: nutrition 
specific and weight, physical exercise, and blood sugar, nutrition general and medical 
treatment (Kartal and Özsoy 2007; Van Der Bijl et al.1999). In the present study, the 
Cronbach’s alpha value was 0.93. 
 
 

Training Booklet and Implementation Steps  
A booklet including information on nursing interventions for diabetes was prepared. 
The training booklet was based on the current literature and the results of the qualitative study 
conducted on the issue in first step of the PhD thesis. The booklet was revised in line with the 
opinions obtained from 5 professors who were experts in the field. The International Standard 
Book Number (978-975-441-462-2 ISBN) for the booklet was obtained by the Presidency of 
Dokuz Eylül University and published in the Dokuz Eylül University Press. 
During the first home visit, the participants in the intervention groupwere applied the 
data collection tools, and then nursing interventions in accordance with the subscales of the 
Health Belief Model by taking into account the individual differences of the participants. The 
nursing interventions were performed within the scope of the basic dimensions of diabetes 
management such as nutrition, exercise, medication management, oral care and foot care. In 
addition, the importance of annual monitoring of HBA1c, blood lipid, albumin / creatinine 
levels, fundus examination, blood pressure monitoring, sleep hygiene, avoidance of smoking 
and alcohol was also explained  (TEMD; 2011; http://www.tdhd.org/dhd_kitap/13blm.pdf 
AD.10.10.2014; 
http://diabetes.niddk.nih.gov/dm/pubs/statistics/#Complications  
AD.15.01.2014;  American Diabetes Association 2014). Home visits were paid 3 times at 3-
month intervals. After the home visits started, reminder messages supporting the home visit 
process were sent at two-week intervals.  
The participants in the control group were contacted 3 times at 3-month intervals 
through telephone calls, and were applied the data collection tools. At the end of the study, the 
participants in the control group were given health training at the Dokuz Eylül University 
Faculty of Nursing and the training booklet was distributed to them. 
Hypotheses of the Study  
Patients with diabetes undergoing home-based nursing interventions in line with the HBM  
H1: have higher mean scores for the Health Belief Model Scale than the control group. 
H2: have higher mean scores for the Self-Efficacy Scale than the control group. 
H3: have lower HbA1c levels than the control group. 
H4: have lower blood glucose levels (BGL) than the control group. 
H5: have lower blood pressure levels than the control group. 
H6: have lower BMI levels than the control group.  
H7: have fewer hospital admissions due to an acute or chronic complication than the 
control group. 
H8: have a lower complication-related cost rate than the control group. 

Analysis of the Data 
The study data were analyzed using numbers, percentages, the chi-square test, the test 
for the Signiﬁcance of the Difference Between Two Means, the Repeated Measures 
Multivariate Analysis of Variance, Bonferroni-adjusted t-test in dependent groups and 
multiple regression analysis in the Statistical Package for Social Sciences (SPSS) (23.0) 
program (Coşansu, 2015; Akgül 2005; Bahar 2004).