Study Design
This was a randomized controlled trial registered at the Iranian clinical trials system under the code of 2013091814512N2. The research was approved by the Ethics Committee of the Lorestan University of Medical Sciences, Khorramabad, Iran.
Participants
Participants were recruited from ten different health centers in Khorramabad, Iran, from February 2017 to April 2018. Out of the five postal districts in this town, health centers were randomly selected, so that individuals with different socioeconomic statuses were included in the study. The inclusion criteria consisted of having age older than 60 years, residing in Khorramabad, Iran, being mentally healthy according to the Iranian health record, and able to perform daily activities independently, and meeting the criteria for self-medication behaviors. Criteria for self-medication behaviors include use of at least a non-prescribed medication for a chronic or acute illness, non-compliance with physician’s order with respect to the prescribed medications such as raising or lowering of the drug dosage, taking the drug for longer or shorter than recommended period of time, refusing to complete the course of treatment, and failing to take the medication on a timely manner. The exclusion criteria included suffering from neurological defects, emigration, failure to participate in more than one training session, or having psychological health deficit.
Sampling and Procedures
The Multistage stratified and cluster sampling method was used for which the area of Khorramabad was divided into 5 strata of north, south, center, east, and west. In each geographical stratum, there were some urban health centers (clusters). From the clusters of each stratum, two were randomly selected by systematic random sampling. A total of ten health centers were selected out of the Khorramabad health centers. Finally, in each selected center, sampling was performed using the non-probability consecutive sampling method until the quota of each center was achieved. The sample size was determined by the formula for calculating the means. The primary sample size in each group (intervention and control) was calculated as 33 individuals using the following formula: (see Formula 1 in the Supplemental Files)
z1-α/2: 97.5th percentile of the standard normal distribution corresponding to type I error probability of 0.05 =1.96
z1-β: 90th percentile of the standard normal distribution corresponding to test power of 0.90=1.28
s: an estimate of the standard deviation of total performance scores change in the both groups=1.26
(see Formula 2 in the Supplemental Files)
d: the minimum mean difference of total performance scores change between the two groups, which is of great importance in the opinion of the researcher. Ultimately, because the cluster sampling method was used, the design effect was set as 2; therefore, the final sample size in each group was estimated to be 66.
Researchers contacted the elderlies through the contact information available in their records and asked them to appear at the assigned health centers for face-to-face interviews. After the interviews, 13 people were excluded from the study due to lack of self-treatment behavior and other entry criteria. Then, 7 people were excluded from the study due to lack of willingness to participate in the study and other reasons, such as migrating to another area.( figure 1)
After taking informed consents by a health care worker who was not involved in the recruitment of participants, the elderly were randomized into the control and intervention groups by permuted block randomization and a table of random numbers [23]. The elderly who met the criteria of self-medication behavior filled out the pre-test questionnaires. In February and March 2017, participants were contacted for face-to-face interviews and the eligibility of seniors was evaluated. In April, May and June 2017, the questionnaires were completed by both intervention and control groups. In July and August 2017, training sessions were held up. The participants in the intervention group received an educational intervention about the regular use of medications in addition to the routine integrated health care services for elderlies. Six months after the intervention was conducted, a researcher who was blinded to group allocation administered the follow-up questionnaires. Post-test questionnaires completed in March and April 2017.
Intervention
The intervention was carried out according to FAEM and included six 45-minute educational sessions. The number of training sessions was determined based on the work of Clark et al., which was performed on elderly population [24]. The adult learning process was implemented in the following three phases listed below.
Listening Phase
The facilitator raised the issue of self-medication by playing a video about elderly individuals suffering from liver and kidney complications due to self-medication. Brainstorming and subsequently a group discussion were held among the elderlies so that they got a chance to share their experiences regarding self-medication behaviors. This way, perceived susceptibility was applied. The elderlies were discussed the need for referring to physicians in the event of chronic or acute illnesses, and the necessity of refraining from obtaining medications from pharmacies without a prescription. They were also alerted against the use of herbal and traditional medicines without a physician’s prescription. Then, perceived severity was persuaded by presenting statistical information and a case study that emphasized the negative consequences of self-medication. The elderlies talked about the various complications associated with self-medication such as prolongation of the disease, increased costs of treating illnesses newly emerged as a result of self-medication, psychological and social burden of losing health such as reduced overall life satisfaction, and limited communication with friends and family.
Reflection Phase
In each group, the elderlies stated the presence of all potential barriers by brainstorming. They role-played about the barriers under discussion, and then a discussion was held up on the solution to the obstacles that were role-played. In this phase, some beliefs were brought up. Those include the idea that health is so important that some time and money should be put aside for visiting doctors, the treatment offered by doctors should be trusted, and that even if they experience severe pain and do not have access to a physician, they should not self-medicate. To modify the structure of perceived benefits, series instructions for taking medications such as proper dosage, timing, and course of treatment were discussed with individuals who had chronic illnesses. A discussion was subsequently played on benefits of refraining from self-medication, including medication safety and receiving quality treatment by medications prescribed by a physician. In the end of this phase, the elderlies expressed their emotional and social concerns to self-medication behaviors. Eventually, the elderly individuals discussed how they can resolve this issue.
Action-Reflection Phase
The behavioral objectives of modifying self-medication behavior were set at this stage. According to these modifications, elderly individual should refrain from taking medications without the prescription of a physician. Likewise, elderly individual should abstain from prolonging or shortening the duration of treatment and complete the course of treatment. Elderly individuals should also avoid increasing or decreasing medication dosage. The elderlies were given recall cards reminding them for regular use of medications in most visible places, such as refrigerators. They read consumer medication information leaflets before taking medications and disposed expired medications. They also created a virtual group with their peers, family members, and health caregivers to monitor their regular use of drugs while share their experiences and educational materials. They also increased the number of authoritative sources such as materials by the Ministry of Health and from health caregivers by which they acquired knowledge on the correct use of medications. This way, the construct of the external cues to action was modified. Additionally, they properly paid attention to their general good health achieved like a result of regular use of drugs as an internal cue to action.
Outcome Measures
The primary outcome was increased knowledge and improved attitude towards self-medication, which were measured by a questionnaire assessing the participants’ knowledge and constructs of HBM at baseline and 6 months following the intervention. The HBM scale was used in a previous researcher’s study that was a descriptive study of self-medication in the elderlies[18].
Part one describes elderly people's knowledge about self-treatment scores 1 for a correct answer while it scores 0 for a wrong one.
Part II Includes questions that assesses the health belief model constructs. The perceived sensitivity of the five items measured a person's belief that they were susceptible to self-medication (Example: I may self-medicate when I am ill). Perceived severity of the five items assessed one's belief about the harmful effects of self-treatment on life (Example: I believe self-therapy may in some cases lead to death). Benefits measured by five items measured one's belief in the usefulness of the correct use of medication (Example: I believe that with the proper use of medication the duration of illness is shorter). Barriers perceived by four items assessed one's perceived ability to cope with the challenges and barriers to proper drug use (Example: Due to the high cost of a physician visit, I cannot see a physician during illness). This questionnaire was rated on a 5-point Likert scale from strongly agree to strongly disagree. “I strongly agree” scores 4, “agree” scores 3, “no idea” scores 2, “disagree scores” 1, and “strongly disagree” scores 0.
The fifth construct of the Health Belief Model is called cues to action, which include accelerating forces that make one's need for self-medication. Two items on internal and external cues to action have been accounted in the form of frequency distributions. The HBM questionnaire had been used in studies by Karimi and Sharifirad performed on elderlies so that the validity and reliability of the questionnaire was confirmed [25, 26].
Section 3 includes reasons of of self-treatment by measuring a 14-item checklist. This questionnaire was answered by yes or no and reported through frequency distribution.
The secondary outcome included a reduction in self-medication behaviors which was assessed at baseline and six months after the intervention. A questionnaire was used including a series of dimensions for the purpose of considering behavioral objectives, and measuring self-medication behaviors. The dimensions included refraining from using medications without physicians’ prescriptions, refraining from prolonging or shortening the duration of treatment, refraining from increasing or decreasing dose, and the regular use of medications according to the assigned time for each. Each dimension was evaluated with two questions about chronic and acute illnesses. The options to each question measured the frequency of the said behavior from Never to More than four times.
Validity
The Health Belief Model provided a conceptual framework for designing the questionnaire. A set of items that measure health belief model constructs on self-medication per capita, were created. This model accurately illustrates the relationship between health beliefs and behaviors. This model is specifically tailored to prevention-based interventions as well as to interventions that make short-term changes[27]. The validity of this questionnaire was evaluated by the following method[28, 29].
Face Validity
Both qualitative and quantitative methods were practical for face validity. For the purpose of qualitative approach, 20 elderies were asked to evaluate each item for imprecision and complexity. In general, there were no problems in reading and understanding the items by elderies. The quantitative face validity was assessed through impact scoring. Impact score for each item was calculated as multiplying the importance of an item with its frequency. The impact scores of greater than 1.5 were considered suitable [30].
Content validity
An expert panel including 10 health educational such as statistics, epidemiology, gerontology, pharmacology and general medicine examined the content validity. The expert panel was asked to examine each question based on the three-part spectrum "necessary", "useful but not necessary" and "not necessary". The results were used to calculate content validity ratio (CVR) using the following formula:
The number of specialists who have chosen the necessary option/////////////// half of all evaluators
----The Formulae---- (see Formula 3 in the Supplemental Files)
Based on the Lawshe’s table, the expressions for which the CVR value was higher than 62.0 were retained for the later stages[31]. In the following, ten experts were asked to comment on the three characteristics of the questionnaire, including relevancy, simplicity and clarity, in a 4-part Likert scale. For example, for the sake of clearance grading, they scored like “is not clear=1 is relatively clear=2, obviously=3, and it is quite obvious=4”. Then, content validity index (CVI) for each item was calculated by dividing the number of experts who agreed with grades 3 and 4 by the total number of specialists .Finally, items were kept with a CVI value greater than 0.79 [28].
Reliability
Internal consistency of the instrument was assessed by using Cronbach’salpha coefficient [32]. Alpha values of equal or greater than 0.70 was thought satisfactory
Statistical Analysis
Stratification variables are presented as frequencies and percentages. They were compared by the chi-square test. Continuous variables are presented as means and standard deviations and tested by paired t-test after evaluating their normality. In order to reduce the effects of the confounding variables, a univariate modeling was used to generate two models. Those included an adjusted model based on the pre-intervention measurements, and a second adjusted model based on the pre-intervention measurements and all the demographic variables. Statistical analyses were performed using SPSS software version 20.0 (IBM) at the significant level of 0.05.
Ethical Considerations
This research project has been registered at the Research Committee of the Lorestan University of Medical Sciences with the registration number of 2040. It was reviewed and approved by the Ethics Committee of the Lorestan University of Medical Sciences. All the participants took part in this study voluntarily. Participants signed a consent form before participation. In order to observe the principles of ethics in research, the educational materials were also made available to the control group at the end of the study.