Design and setting of the study
This study was a parallel randomized clinical trial. This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT) with the registration number IRCT20221231057000N2. In this clinical trial, participants were randomly assigned to either the intervention or control group. The setting for this study was comprehensive health service centers in the urban areas of Gorgan, Golestan Province.
Participant characteristics
The study population included all individuals aged 65 years and older from urban community dwellers in the city of Gorgan. Participants who referred to comprehensive health service centers, 110 eligible participants were selected via a consecutive sampling method. The city of Gorgan is divided into three municipal districts. Two centers were randomly selected from each district, and samples were selected proportionally from elderly community dwellers.
The inclusion criteria were as follows: age 65 years and older; orientation to time, place, and person; ability to comprehend educational instructions; independence in activities of daily living as measured by a Katz ADL (score of 5 or 6); and a Mini-Mental State Examination score greater than 18. The exclusion criteria for the participants included those who were diagnosed with physical or psychiatric illnesses and those concurrently enrolled in similar educational programs.
To determine the sample size for each dependent variable, the following formulas were considered on the basis of similar studies. For the outcome of fall self-efficacy, using the study of Sadeghigolafshani et al. and considering a type I error of 0.05 and a power of 85%, the required sample size was estimated to be 30 people per group (26). For the outcomes of self-care and quality of life, using the study by Asgharian et al. and considering a type I error of 0.05 and a power of 85%, the required sample sizes were estimated to be 49 and 26 people per group, respectively (28). Considering the maximum sample size and a 10% attrition rate, a total of 55 participants were estimated per group.
$$\:n=\frac{{\left({z}_{\left(1-\alpha\:/2\right)}+{z}_{\left(1-\beta\:\right)}\right)}^{2}\left({\sigma\:}_{1}^{2}+{\sigma\:}_{2}^{2}\right)}{{\left({\mu\:}_{1}-{\mu\:}_{2}\right)}^{2}}=\frac{{\left(1.96+1.04\right)}^{2}\left({18}^{2}+{32}^{2}\right)}{{\left(128-108\right)}^{2}}=30.33\:\frac{{\left(1.96+1.04\right)}^{2}\left({5.4}^{2}+{3.7}^{2}\right)}{{\left(58.7-61.5\right)}^{2}}=49.19$$
,
,\(\:\frac{{\left(1.96+1.04\right)}^{2}\left({5.4}^{2}+{4.2}^{2}\right)}{{\left(79.6-75.6\right)}^{2}}=26.3\)
The primary investigator visited each comprehensive health service center, identified eligible individuals, and assigned them to either the intervention or control group via an allocation sequence hidden in opaque envelopes. The participants were assigned to groups according to the order in which they entered the study. Allocation sequence concealment was achieved via 110 numbered opaque envelopes, each containing a unique allocation sequence. To ensure a balanced allocation of participants to both groups and to accommodate the gradual enrolment of elderly individuals, a block randomization procedure with a block size of 4 was employed. The random allocation sequence was generated in collaboration with a methodological consultant.
Owing to the nature of the study, it was not possible to blind the participants. Prior to the intervention and prior to the allocation of participants to groups, questionnaires were completed by an individual who was unaware of group allocation. After the intervention, the same individual, who was blind to group allocation, completed the questionnaires. (Fig. 1).
Intervention
Prior to random allocation, all participants provided informed consent (written and verbal) and completed baseline assessments, including demographic data and questionnaires on ABCs, elderly self-care, and WHO-5 well-being. The participants were subsequently randomly assigned to either the intervention group or the control group. The control group received routine care and counselling from comprehensive health service centers. The intervention group underwent an individual empowerment program based on the 5A model, which, considering previous studies (22, 23, 27), was implemented over a 12-week period. After the 12-week intervention, the ABCs, elderly self-care, and WHO-5 well-being questionnaires were completed again by both groups through self-reports. The 5A model consists of five stages: Assess, Advise, Agree, Assist, and Arrange (25). (Table 1) (Fig. 2).
The first and second stages of the 5A model were conducted in the first session, individually and in person, lasting 60–75 minutes. The third stage was implemented individually during the second session via a 15- to 30-minute telephone call. The second session was held three days after the first session. The first three stages were carried out during the initial week. The fourth stage was conducted in person as a 90-minute group session during the third session in the second week. At this stage, individuals with similar problems are grouped together. The fifth stage (follow-up) was conducted via telephone calls from the third to the twelfth week. Follow-up was conducted three times a week during the first two weeks, twice a week during the second two weeks, and once a week thereafter. In-person sessions were held in a classroom setting at comprehensive health service centers, whereas remote sessions were conducted via telephone.
Table 1
Stages of 5A model | Sessions | Goals | Duration | Session content |
The first two stages (assess and advice) | The first session | Assess: Evaluation of behavioral health risks and identification of patient problems. Advice: Providing information about the benefits of behavior change. | From 60 to 75 minutes | In the first stage, a comprehensive review of the patient's medical history was conducted, including a falls history, family history, body mass index, medication use, diet, sleep patterns, comorbidities, activity level, social engagement, symptoms, risk factors. Questionnaires and assessment forms were used to gather this information. In the second stage, patients were individually informed about the abnormal findings and problems identified in the initial stage, along with the benefits of behavior change. Information regarding the consequences and complications of, the fear of falling, falls, and the benefits of falls prevention behaviors and self-care activities was conveyed to the elderly participants. |
The third stage (agree) | The second session | Agreeing on specific goals and an operational plan for behavior change. | From 15 to 30 minutes | In collaboration with the older adults, an operational plan was designed based on the problems identified in the first stage, taking into account the individual's goals and willingness to change behaviors and reduce challenges. To ensure adherence to the agreed-upon program, the elderly were asked to self-report their functional status on a weekly basis for each of the designated activities and report these findings to the researcher during follow-up. |
The fourth stage (assist) | The third session | Assisting the patient in identifying barriers and developing strategies for overcoming them and develop an action plan. | 90 minutes | In this session, training on fear of falling and falls was provided based on a booklet developed using guidelines from the WHO and other relevant articles and papers on fear of falling and falls. The content validity of the booklet was confirmed by relevant professors at Shahroud University of Medical Sciences. During the session, the elderly participants received training on falls prevention strategies, the nature, causes, consequences, and risk factors associated with falls and fear of falling, as well as simple balance exercises. Additionally, the participants received education on self-care, including physical self-care practices such as adhering to medication and dietary regimens, maintaining personal hygiene, engaging in regular physical activity, and ensuring sufficient sleep and rest. The training utilized a variety of methods, including lectures, question-and-answer, and the distribution of informational materials such as booklets and pamphlets. |
The fifth stage (arrange) | Sessions 4 to 19 (During weeks 3 to 12) | Follow-up to review the agreed-upon plan and reinforce previous education and steps. | Each session lasts 15 to 30 minutes | At this stage, the previous four stages, the agreed-upon program, and the training provided in the fourth stage were reviewed with the elderly to reinforce motivation, recall the intervention, and ensure adherence. Operational plans requiring modification were revised, and any additional training needs expressed by the participant were addressed. |
Data collection
The data collection instruments used in this study included a demographic form, the Activities-Specific Balance Confidence scale to measure falls self-efficacy, the Elderly Self-Care Questionnaire, and the WHO-5 Well-Being Index to assess quality of life.
The demographic data included age, weight, height, gender, marital status, occupation, fall history, education, number of drugs consumed, social activity, and history of chronic diseases.
The activity-specific balance confidence (ABC) scale was initially developed by Powell and Myers in 1995 to assess confidence in maintaining balance among older adults (10). The ABCs is a 16-item scale. Each item is rated on a 100-point scale, with 0 indicating no confidence and 100 indicating complete confidence (8). The maximum possible score is 1600, and the minimum is zero. To calculate an individual's score, the sum of their scores on all the items is divided by 16. The participants were asked to select a percentage to indicate their level of confidence in performing the activity without losing balance or experiencing instability (8, 10). A score of 67 or higher indicates greater confidence in performing specific activities related to falling, whereas a score below 67 suggests lower confidence (8, 10). In Powell and Myers' study examining convergent validity, the ABCs demonstrated a strong positive correlation with the physical activity subscale (r = .63, p < .001) and a moderate positive correlation with the physical self-efficacy scale (r = .49, p < .001). This study demonstrated good construct validity among the elderly population. Cronbach's alpha was .96, indicating high internal consistency of the ABC scale. Furthermore, the total ABC score exhibited high stability over a two-week period (r = .92, p < .001) (10). In the study by Hassan et al., Persian translation and cultural adaptation were conducted according to the International Quality of Life Assessment (IQOLA) protocol. Two proficient translators, unfamiliar with the questionnaire, independently translated the original English version of the ABC scale into Persian. The resulting version was then provided to two other translators, who independently rated the quality of the Persian translation on a scale of 0–100. The final translation was given to two more proficient translators who back-translated the scale into English. The English translation obtained from this stage, along with the Persian translation and the original version, was presented to 12 experts in the field of balance, who evaluated the quality of the translation and its cultural adaptation. To assess the facial validity of the Persian version of the scale, the instrument was administered to 10 elderly individuals representative of the study population. Reliability in this study was confirmed via a Cronbach's alpha coefficient of 0.96 and an ICC of 0.97 (30).
The Self-Care Questionnaire for the Elderly (in Persian) was designed and psychometrically tested by MaslakPak and Hashemloo in 2015. This questionnaire consists of 40 items scored on a 4-point Likert scale (often, sometimes, rarely, never). For positive statements, a score of 1 indicates 'never', and a score of 4 indicates 'often'. Conversely, for negative statements, a score of 1 indicates 'often', and a score of 4 indicates 'never'. The minimum score on this questionnaire was 40, and the maximum score was 160. A higher score indicates a greater level of self-care ability. This questionnaire assesses physical, daily, emotional, social, and illness-related self-care dimensions in elderly people. The face, content, and construct validity of this questionnaire were confirmed in MaslakPak's study. Specifically, the construct validity was supported by the confirmation of a five-factor structure. The content validity of this questionnaire was assessed on the basis of the judgments of experts in instrument design and other relevant fields and the Lawshe table and the content validity index of Waltz and Bales. A content validity index (CVI) score exceeding 0.79 was deemed appropriate for the acceptance of items. To assess the facial validity of the instrument, ten elderly individuals were recruited and asked to provide feedback on the ease of completing the questionnaire, the grammar and spelling of the words, and the clarity of the item wording. Construct validity was assessed via factor analysis. The results of the Kaiser‒Meyer‒Olkin measure (KMO = 0.777) and Bartlett’s test (p < .001) indicated that the factor analysis model was appropriate. The questionnaire demonstrated high internal consistency, with a Cronbach's alpha coefficient of 0/864 (31).
The WHO-5 Well-Being Index was developed in 1998 to measure positive well-being over the past two weeks (32). This questionnaire consists of 5 items and employs a 6-point Likert scale for scoring. The response options range from 'At no time' (scored 0) to 'All of the time' (scored 5), with intermediate options including 'Some of the time', 'Less than half the time', 'More than half the time', and 'Most of the time'. The minimum possible score is 0, indicating the absence of well-being, whereas the maximum score is 25, indicating optimal well-being. Higher scores are indicative of greater well-being, whereas lower scores suggest depressive tendencies. To convert the score range to a 0-100 scale, the raw score can be multiplied by 4 (33, 34). In the study by Eser et al., the construct validity of the questionnaire was demonstrated by its ability to differentiate between various demographic groups. The questionnaire was able to discriminate between individuals on the basis of age, gender, education level, income, and marital status. Education level and income emerged as the strongest differentiating variables (32). Furthermore, in this study, the Cronbach's alpha coefficient was reported to be 0.81 for adults and 0.86 for elderly individuals, indicating good internal consistency of the questionnaire (32). In the study by Dehshiri and Mousavi, the construct validity of the Persian version of this questionnaire was confirmed with a single-factor structure. The factor loadings of the items ranged from 0.79–0.87, indicating a suitable level. In this study, the internal consistency reliability of the questionnaire was assessed via the internal consistency method. The item‒total correlations ranged from 0.53 to 0.77, with a mean of 0.63, and Cronbach's alpha was found to be 0.89 (33).
Data analysis
Data were analyzed via descriptive statistics (means, standard deviations, frequencies, and percentages). Chi-square or Fisher's exact tests were used to compare qualitative variables (frequencies or percentages), whereas independent t-test were used to compare the means of quantitative variables between the control and intervention groups. An independent t-test was used to examine the effect of the intervention on changes in fall self-efficacy scores and other outcomes. Covariance analysis was used to assess the intervention effect, controlling for education level.
This study was conducted with the approval of the esteemed Research Deputy and Research Ethics Committee of Shahroud University of Medical Sciences (Ethics Code: IR.SHMU.REC.1402.137) and with permission from the esteemed officials of the research setting (Deputy of Health and Research, Golestan University of Medical Sciences) in the comprehensive health service centers of the city of Gorgan.