Design, procedure and the study sample
This study was conducted as an educational randomized controlled trial (single blind) on 120 patients with diabetes referring to the County Diabetes Clinic in the city of Kashan, Iran from 2017 to 2018. The population of the current study included all the diabetic patients admitted to Diabetes Clinic (N = 2500).
According to the study Baghiani Moghadam et al. [15] with considering a equal to 5% and β to 0.1 using the following formula, the sample size was calculated as 58 participants in each group of control and intervention, which this number increased to 60 considering sample loss. So, the total sample size was 120. (see Formula 1 in the Supplementary Files)
In this study having means of 10.8 and 12.42 and standard deviations of 2.79 and 2.57 for the intervention group before and after the intervention for perceived susceptibility construct respectively in Baghiani Moghadam et al. [15] an effect rate of 0.6 was obtained indicating a large effect size and the same effect rate was considered for this study.
Out of the patients having medical records in the clinic, 120 patients were selected through systematic sampling and were randomly (every other person) assigned to two 60-member groups: control and intervention.
Random allocation was achieved using sealed numbered envelopes developed so that randomization is computer-generated. A research assistant who was not involved in the recruitment of participants prepared the envelopes. Participants allocated to the control group (n= 60) received standard care. Participants assigned to the intervention group (n= 60) also received standard care plus the educational intervention based on HBM.
Three months after the intervention, the posttest was conducted for both intervention and control groups to examine the effects of education on the primary and secondary outcomes.
The primary outcomes of the current research include the construct of HBM (Perceived Susceptibility, severity, benefit, barrier, cues to action and self-efficacy). The secondary outcome was oral and dental health behavior's.
According to the panel of experts, three months of follow-up was considered sufficient time to establish consistency, stability, and sustainability in oral health care behaviors.
Based on the nature of the intervention in the current study, the instructor was not blinded to group assignment, but participants and statistical investigator were blinded to group assignment.
Inclusion criteria were having medical records in the Diabetes Clinic, being at the age range of 40-60 years, being literate, living in the city of Kashan, having no oral symptoms, having no history of radiotherapy and hemodialysis, not having another chronic systemic illnesses, not consuming medicines with complications such as dry mouth, not wearing dentures and signing informed consent form to participate in the study. Exclusion criteria were not being willing to participate in the study, moving from Kashan, not being continuously present in training sessions and being afflicted with any condition.
The conceptual framework of conducting this study was that according to the study criteria, the samples were selected by referring to the diabetes clinic and divided into control and intervention groups. Then pretest was administered to both groups based on the questionnaire and the intervention group received training based on the Health Belief Model. By utilizing the perceived susceptibility construct, patients are firstly exposed to oral and dental problem and understand the complications and at the same time they are taught the benefits and barrier of preventive behaviors. Then by utilizing the internal and external cues to action and increasing patients' self-efficacy, they were taught behaviors related to oral care. The control group also received routine diabetes clinic training. Then the patients were followed for three months and then posttest was administrated and the effect of education on their preventive behaviors was re-evaluated.
Figure 2 shows the framework and flow diagram of the participants during the study period.
Measures
The data collection tool in this study was a valid and reliable researcher-made questionnaire consisting of questions on demographic information, awareness, constructs of the health belief model and performance in oral hygiene-related behaviors in patients with T2DM. The validity and reliability of this questionnaire was approved and it was completed before the training intervention and three month after the intervention by both control and intervention groups. In this tool, those questions with Content Validity Ratio (CVR) score higher than 0.62 and Content Validity Index (CVI) score higher than 0.79 were considered as appropriate and included in the study [16].
To verify its reliability, the questionnaire was given to 30 diabetes patients and its reliability was calculated as 0.866 using Cronbach’s alpha. The validity of the questionnaire was also approved by three hygiene training experts, three internal diseases specialists, one endocrinologist, one dentist, and one expert having a PhD in epidemiology and one executive focal point in the National Program for Prevention and Control of Diabetes (NPPCD) of Iran after removing or modifying some of its statements.
The diabetes patients’ awareness of oral care questionnaire consisted of 9 questions. The health belief model constructs questionnaire on oral hygiene-related behaviors consisted of perceived susceptibility (7 questions), perceived severity (10 questions), perceived barriers (7 questions), perceived benefits (8 questions), self-efficacy (11 questions), internal cues to action (triggers) (4 questions) and external cues to action (5 questions). The performance questionnaire on oral hygiene-related behaviors also consisted of 10 questions.
Scoring
For the awareness the correct answer scored 1 and the wrong one scored 0 and the total score of awareness was calculated out of 9.
The questions of the health belief model constructs were scored on a 5-point scale from strongly agree, agree, no idea, disagree and strongly disagree scoring 1 to 5.
Therefore the scores range of each model construct was finally calculated and reported between one and five.
The questions of performance questionnaire were scored on a 5-point scale of behavior evaluation from never, rarely, sometimes, often and always scoring from 0 to 4 and the scores in this part were reported out of 4.
In this study higher score indicate higher level of awareness, perceived (susceptibility, severity, benefit, barrier, cues to action, self-efficacy) and performance of oral hygiene in patient of diabetics.
Intervention
Before performing the training intervention and in pretest stage, the questionnaires were completed by both groups and entered the computer to be used for determining the training needs and the constructs to be presented in training sessions. Then, according to the health belief model and based on the results of the needs analysis, the training program was prepared for four 120-minute sessions in one month targeted at the intervention group. The materials were presented in the sessions through lectures, question and answer, slide presentation, pamphlets and booklets to benefit all the time in class and make the training available for further study by the patients.
In the first training intervention sessions, awareness of diabetes patients was emphasized aiming at gaining an appropriate knowledge of diabetes and factors affecting deterioration and acceleration of oral complications, the second session's focus on; perceived susceptibility and severity was touched by presenting the statistics on prevalence of oral problems resulted from diabetes and vulnerability of patients and severity of oral complications resulted from inappropriate blood sugar control and not performing oral hygiene-related behaviors. The third session's focus on perceived benefit, barrier and cues to action; the materials of these sessions emphasized on the benefits resulted from performing oral hygiene-related behaviors (reduced oral complications, reduced need to dentistry services and lower medical expenses, feeling of calmness and internal joy), identifying and removing perceived barriers on the way of performing oral hygiene-related behaviors (unawareness, bodily weakness, fatigue, feeling bored, etc.) external cues to action affecting performing oral hygiene-related behaviors (including physicians, diabetes clinic nurses, family members, television, books and magazines in health centers, other diabetes patients) and the role of internal cues to action or triggers (motivation and internal calmness resulted from performing hygiene-related behaviors) were emphasized. The fourth session's focus on perceived self-efficacy and performance of oral and dental health hygiene behaviors; Self-efficacy construct was emphasized by empowering the patients by the aim of facilitating performance of hygiene-related behaviors through presenting educational images on slides, practical training and distributing packages consisting of a toothbrush, a toothpaste and a floss threader among the patients and providing them with booklets and pamphlets. The performance dimension was approached through operationalizing oral hygiene-related behaviors by patients (brushing the teeth, using a floss threader, washing the tongue, massaging the gum, performing preventive behaviors and caring for probable oral complications of diabetes).
In this study control group received only standard (routine) care with County Diabetes Clinic. It is noteworthy that standard care in Iran includes monthly visits at a healthcare clinic from a doctor, a dietitian, and a nurse and lasts for less than 20 min. These visits were held individually or in groups.
Three months after the training intervention, the questionnaire was given again to the both groups and the all 120 patients completed them.
Statistical analysis
The data were analyzed using SPSS 20 through descriptive and inferential statistics (including independent t-test, paired t-test, Chi-square). The significance level was considered at 0.05. To investigate the normality of the data, Kolmogorov-Smirnov test was used and normal distribution of the data was obtained.
Concerning the gender difference between diabetic men and women with regard to oral hygiene behaviors(which the reviewer considered), due to the small size of the groups (men and women), the distribution of data was non normal and nonparametric tests (Wilcoxon and Mann-Whitney) were used.
The primary outcomes of the current research include the construct of HBM (Perceived Susceptibility, severity, benefit, barrier, cues to action and self-efficacy). The secondary outcome was oral and dental health behavior’s.
The data collection tool in this study was a valid and reliable researcher-made questionnaire consisting of questions on demographic information, awareness, constructs of the health belief model and performance in oral hygiene-related behaviors in patients with T2DM. The validity and reliability of this questionnaire was approved and it was completed before the training intervention and three month after the intervention by both control and intervention groups. In this tool, those questions with CVR score higher than 0.62 and CVI score higher than 0.79 were considered as appropriate and included in the study [15].
To verify its reliability, the questionnaire was given to 30 diabetes patients and its reliability was calculated as 0.866 using Cronbach’s alpha. The validity of the questionnaire was also approved by three hygiene training experts, three internal diseases specialists, one endocrinologist, one dentist, and one expert having a PhD in epidemiology and one executive focal point in the National Program for Prevention and Control of Diabetes (NPPCD) of Iran after removing or modifying some of its statements.
The diabetes patients’ awareness of oral care questionnaire consisted of 9 questions. The correct answer scored 1 and the wrong one scored 0 and the total score of awareness was calculated out of 9.
The health belief model constructs questionnaire on oral hygiene-related behaviors consisted of perceived susceptibility (7 questions), perceived severity (10 questions), perceived barriers (7 questions), perceived benefits (8 questions), self-efficacy (11 questions), internal cues to action (triggers) (4 questions) and external cues to action (5 questions).
The questions of the model constructs were scored on a 5-point scale from strongly agree, agree, no idea, disagree and strongly disagree scoring 1 to 5. The lowest and highest scores in each part of questions of health belief model constructs was different due to the different number of the questions of each construct. So, the score of each dimension was calculated out of 5.
The performance questionnaire on oral hygiene-related behaviors also consisted of 10 questions. This questions of this questionnaire were scored on a 5-point scale of behavior evaluation from never, rarely, sometimes, often and always scoring from 0 to 4 and the scores in this part were reported out of 4.
Before performing the training intervention and in pretest stage, the questionnaires were completed by both groups and entered the computer to be used for determining the training needs and the constructs to be presented in training sessions. Then, according to the health belief model and based on the results of the needs analysis, the training program was prepared for four 120-minute sessions in one month targeted at the intervention group. The materials were presented in the sessions through lectures, question and answer, slide presentation, pamphlets and booklets to benefit all the time in class and make the training available for further study by the patients.
In the training intervention sessions, awareness of diabetes patients was emphasized aiming at gaining an appropriate knowledge of diabetes and factors affecting deterioration and acceleration of oral complications; perceived susceptibility and severity was touched by presenting the statistics on prevalence of oral problems resulted from diabetes and vulnerability of patients and severity of oral complications resulted from inappropriate blood sugar control and not performing oral hygiene-related behaviors. Also, the materials of these sessions emphasized on the benefits resulted from performing oral hygiene-related behaviors (reduced oral complications, reduced need to dentistry services and lower medical expenses, feeling of calmness and internal joy), identifying and removing perceived barriers on the way of performing oral hygiene-related behaviors (unawareness, bodily weakness, fatigue, feeling bored, etc.) external triggers affecting performing oral hygiene-related behaviors (including physicians, diabetes clinic nurses, family members, television, books and magazines in health centers, other diabetes patients) and the role of internal cues to action or triggers (motivation and internal calmness resulted from performing hygiene-related behaviors) were emphasized. Self-efficacy construct was emphasized by empowering the patients by the aim of facilitating performance of hygiene-related behaviors through presenting educational images on slides, practical training and distributing packages consisting of a toothbrush, a toothpaste and a floss threader among the patients and providing them with booklets and pamphlets. The performance dimension was approached through operationalizing oral hygiene-related behaviors by patients (brushing the teeth, using a floss threader, washing the tongue, massaging the gum, performing preventive behaviors and caring for probable oral complications of diabetes).
Three months after the training intervention, the questionnaire was given again to the both groups and the all 120 patients completed them.