Study design
This was a randomized controlled trial registered at the Iranian clinical trials system under the code of 2,013,091,814,512 N2. 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 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 being older than 60 years [24]Footnote 2 residing in Khorramabad, Iran, being mentally healthy according to the Iranian health records, being able to perform daily activities independently, and meeting the criteria for self-medication behaviors. Criteria for self-medication behaviors included use of at least a non-prescribed medication for a chronic or acute illness, non-compliance with physician’s orders with respect to the prescribed medications such as raising or lowering medicine dosage, taking medicine 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, failing to participate in more than one training session, or having psychological health deficits.
Sampling and randomization
The multistage non-probability quota method was used for which the area of Khorramabad was divided into 3 strata of north, south and center. In each geographical stratum, there were some urban health centers. From the health centers of each stratum, two were randomly selected by systematic random sampling. A total of six 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 filled.
Patients were assigned to the intervention (n = 66) and control (n = 66) groups using permuted block randomization with a block size of 2 and an allocation ratio of 1:1. By use of random number table for each selected healthcare centers, a random sequence of “intervention” and “control” was generated. A column is randomly selected from the table of random numbers. The numbers are read from top to bottom. For numbers between 0 and 4, the words were sequenced as of “intervention” and then “control”. While, for the numbers between 5 and 9, the words were sequenced by “intervention” was followed by “control”. Finally, tables were installed in health centers, and the sampler selected intervention or control as the first experimental group for the first qualified person. Obviously, the next word should be used based on the random sequence method [25]. The primary sample size in each group (intervention and control) was calculated as 63 individuals using the following formula:
$$ n=\frac{{\left({z}_{1-\raisebox{1ex}{$\alpha $}\!\left/ \!\raisebox{-1ex}{$2$}\right.}+{z}_{1-\beta}\right)}^2\left(2{s}^2\right)}{d^2} $$
z1-α/2: 97.5th percentile of the standard normal distribution corresponding to type I error probability of 0.05 = 1.96.
z1-β: 80th percentile of the standard normal distribution corresponding to test power of 0.90 = 0.84.
s: an estimate of the standard deviation of total performance score change in both groups = 2.00
$$ \left({\sigma}_{change}=\sqrt{\sigma_{before}^2+{\sigma}_{after}^2-2{\rho \sigma}_{before}{\sigma}_{after}}\simeq \sqrt{2^2+{2}^2-2\times 0.5\times 2\times 2}\simeq 2.00\right) $$
d: the minimum mean difference of total performance score change between the two groups, which is of great importance in the opinion of the researcher = 1. Ultimately, considering the probability of 5% for loss of samples, the final sample size in each group was estimated to be 66.
Researchers contacted the selected older adults 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. Criteria for self-medication behaviors included use of at least a non-prescribed medication for a chronic or acute illness, non-compliance with physicians’ orders with respect to the prescribed medications such as raising or lowering medicine dosage, taking medicines for longer or shorter than the recommended period of time, refusing to complete the course of treatment, and failing to take medications in a timely manner. Four of them were reluctant to participate in the study. Three of them were also unable to perform their activities independently due to neurological defects or mental disorders such as dementia. Therefore, they were unable to take care of themselves so that we could not investigate the arbitrary use of medicine among them. Therefore, the collected data might not have been reliable if they were included.
After informed consent was obtained by a healthcare worker who was not involved in the recruitment of participants, the older adults were randomized into control and intervention groups by permuted block randomization and a table of random numbers [26]. The older adults who met the criteria of self-medication behavior filled out the pre-test questionnaires. The corresponding author and research assistants collected the data. The research assistants were graduate students majoring in public health. In February and March 2017, participants were contacted for face-to-face interviews and to assess their eligibility to participate. 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 older adults. Six months after the intervention was conducted, a researcher who was blinded to group allocation administered the follow-up questionnaire. The post-test questionnaire was completed in March and April 2017.
Intervention
The intervention was carried out according to FAEM and included six 45-min educational sessions. The number of training sessions was determined based on the method proposed by Clark et al., which was performed on older adult populations [27]. The adult learning process was implemented in the three phases listed below.
Listening phase
The facilitator raised the issue of self-medication by playing a video about older adult individuals suffering from liver and kidney complications due to self-medication. Brainstorming and subsequently a group discussion were held among the older adults so that they got a chance to share their experiences regarding self-medication behaviors. This way, perceived susceptibility was applied. The older adults were advised about 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 older adults talked about the various complications associated with self-medication such as prolongation of the disease, increased costs of treating illnesses 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 older adults discussed potential barriers by brainstorming. They role-played about the barriers under discussion followed by a discussion about the solution to the obstacles that were role-played. In this phase, some beliefs were brought up, including 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, a series of 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 held on the benefits of refraining from self-medication, including medication safety and receiving quality treatment through medications prescribed by a physician. At the end of this phase, the older adults expressed their emotional and social concerns about self-medication behaviors. Eventually, the older adult individuals discussed how they could resolve this issue.
Action-reflection phase
The behavioral objectives of modifying self-medication behavior were set at this stage. According to these objectives, older adults should refrain from taking medications without the prescription of a physician. Likewise, older adults should abstain from prolonging or shortening the duration of treatment and complete the course of treatment. Older adult individuals should also avoid increasing or decreasing the medication dosage. The older adults were given recall cards that could be put in the most visible places, such as on refrigerators in order to remind them to take their medications on time. 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 medicine while sharing 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. Thereby, the construct of external cues to action was modified. Additionally, they paid proper attention to their achieved general health because of regular use of medications as an internal cue to action.
Outcome measures
The primary outcome was increased knowledge and improved attitude towards self-medication, measured by a questionnaire assessing the participants’ knowledge and constructs of HBM at baseline and 6 months following the intervention. The HBM scale has been used in a previous descriptive study of self-medication in older adults [19].
Part one describes older adults’ knowledge of self-treatment. A score of 1 indicates a correct answer while a score of 0 is considered a wrong one. Part II includes questions that assess the health belief model constructs. Five items about perceived sensitivity measured a person’s belief if they were susceptible to self-medication (Example: I may self-medicate when I am ill). Five items about perceived severity 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). Five items concerning perceived benefits measured one’s belief in the usefulness of the correct use of medications (Example: I believe that with the proper use of medications the duration of illness is shorter). Four items on perceived barriers assessed one’s perceived ability to cope with challenges and barriers to proper use of medications (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. Then, the obtained score is expressed as a percentage. The total score ranged from 0 to 100.
The fifth construct of Health Belief Model is called cues to action, which guide one’s need or actions with regard to self-medication. Internal and external cues to action have been accounted in the form of frequency distributions. The HBM questionnaire has been used in studies by Karimi and Sharifirad performed on older adults so that the validity and reliability of the questionnaire has been confirmed [28, 29].
Section 3 includes reasons for self-treatment as assessed by 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 time assigned 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 behaviors 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 were created. This model accurately illustrates the relationship between health beliefs and behaviors. This model is specifically tailored for prevention-based interventions as well as interventions that make short-term changes [30]. The validity of this questionnaire was evaluated by the following method [31, 32].
Face validity
Both qualitative and quantitative methods were used for face validity. For the purpose of qualitative approach, 20 participants were asked to evaluate each item for imprecision and complexity. In general, there were no problems in reading and understanding the items by participants. The quantitative face validity was assessed by impact scoring. The impact score for each item was calculated by multiplying the importance of an item by its frequency. The impact scores of greater than 1.5 were considered suitable [33].
Content validity
An expert panel including experts such as a health education expert, a statistician, an epidemiologist, a gerontologist, a pharmacologist and a general practitioner 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 the content validity ratio (CVR) using the following formula:
The numbers of specialists who have chosen the necessary option/half of all evaluators.
----The Formula----
$$ CVR=\frac{n_E-\frac{N}{2}}{\frac{N}{2}} $$
Based on Lawshe’s table, the expressions for which the CVR value was higher than 62.0 were retained for later stages [34]. Next, ten experts were asked to comment on 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, is clear=3, and is quite clear=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 with a CVI value greater than 0.79 were reserved [31].
Reliability
The internal consistency of the instrument was assessed using Cronbach’s alpha coefficient [35]. Alpha values equal or greater than 0.70 were considered as satisfactory.
Statistical analysis
Stratification variables have been presented as frequencies and percentages. They were compared by the chi-square test. Continuous variables have been presented as means and standard deviations and tested by paired t-test after evaluating their normality. In order to reduce the effects of confounding variables, two different ANOVA models were used. They include an ANOVA model which was only adjusted for basic variables. The second ANOVA model was adjusted for basic as well as demographic variables. Statistical analyses were performed using SPSS software version 20.0 (IBM) at the significance level of 0.05.
Ethical considerations
This research project has been registered at the Research Committee of Lorestan University of Medical Sciences with the registration number 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.