This quasi-experimental study involved two groups and was conducted with the research population consisting of all MS patients referred to the Zahedan Multiple Sclerosis Association in 2023. Inclusion criteria were literacy in reading and writing, having a record at the Multiple Sclerosis Association, access to a mobile phone and the Internet, a minimum disease history of 1 year, an Expanded Disability Status Scale (EDSS) score ≤ 4 (indicating sufficient self-care ability), and not being part of the treatment staff. Exclusion criteria included a person’s refusal to participate further in the research and the occurrence of a severe stressful event during the study.
The sample size for each group was determined to be 8 based on the mean fatigue score from a similar study involving MS patients. The calculation considered a 95% confidence interval and 95% test power using the following formula (
32):
Where Z1 - α/2 = 1.96; Z1 - β = 1.64; S1 = 1.96; S2 = 1.70; ; .
To ensure an adequate sample size, accounting for possible dropouts, 40 individuals were included in each group, resulting in a total of 80 participants. Simple random assignment was employed to allocate selected patients to either the control or intervention groups. In this method, the first sample was assigned to the intervention or control group through a lottery process, followed by alternately placing the subsequent research units into each group.
Subsequently, the researcher collected data on patient characteristics and fatigue through patient interviews. A demographic information form was utilized to record patient characteristics, encompassing sex, age, employment status, education level, marital status, ethnicity, duration of MS, number of hospitalizations in the past year, number of disease attacks, changes in the dosage of disease-modifying drugs, and management of disease complications. The EDSS was administered to assess the participants’ level of disability. Scores on this scale range from 0 (normal neurological examination) to 10 (MS-related death). Lower scores indicate less severe disability, while higher scores indicate greater disability. A neurologist conducted the grading, and the questionnaire’s validity and reliability were previously confirmed. Cronbach's alpha of 0.82 is mentioned in the instrument manual for reliability, and in this study, reliability was not measured again for this tool (
33).
The Fatigue Severity Scale (FSS), developed by Krupp et al., measured fatigue in MS patients. This tool consists of 9 items, with 5 items assessing the quality of fatigue, including physical and mental fatigue, and the impact of fatigue on the individual’s social status. Additionally, 1 item compares the intensity of fatigue with other symptoms experienced by MS patients. Each question is scored on a scale from 1 to 7, with the fatigue score ranging from 9 to 63. Higher scores indicate more significant fatigue. Responses are scored on a 5-point Likert scale, where a score of 1 indicates complete disagreement with the statement, and a score of 7 indicates complete agreement (
34). The validity of the questionnaire has been confirmed and its reliability has been confirmed with Cronbach's alpha coefficient of about 96% (
35). In the current study, the tool’s reliability was further confirmed with a Cronbach’s alpha value of 0.85.
First, the neurologist completed the EDSS by conducting a face-to-face interview with the patient at their bedside. Patients who scored higher than 4 were not included in the study. Then, participants in both the intervention and control groups completed the demographic information form and FSS through face-to-face interviews.
In the intervention group, patients participated in a mobile health training program via a website created by the researcher. Patients in this group received fatigue self-care training through podcasts and videos, and they were provided with information about the website’s address and how to use it. Each patient was assigned a unique ID and password. The training content was uploaded to the site every week for 6 weeks on Saturdays, and patients could ask the researcher questions at any time by leaving a text or voice message. The researcher responded to their queries through podcasts or text messages. The implementation of the program was also followed up with weekly phone calls on Wednesdays for 6 weeks, with one call each week.
Two months after the initial measurement, the researcher conducted face-to-face interviews with patients at the Multiple Sclerosis Association to complete the FSS once again. Patients in the control group received the usual training provided by the staff of the Association. Two months after the initial assessment, the control group patients were interviewed in person to complete the FSS questionnaire.
As presented in
Table 1, the mobile health training program primarily focused on strategies to reduce and manage the causes of fatigue, along with energy conservation methods. All sessions were conducted through the researcher’s video clips and podcasts, using simple and understandable language without any medical jargon.
| Sessions | Contents | Duration, min |
|---|
| 1 and 2 | Energy conservation solutions: Scheduled rest, sleep hygiene, treatment of infections, and organizing living space | 4 and 4 |
| 3 and 4 | Ways to reduce fatigue: Overcoming heat, noise, and stress, correcting light and height and body position, planning and exercise | 4 and 4 |
| 5 and 6 | Healthy eating and controlling and changing useless thoughts | 4 and 5 |
The collected data were analyzed using SPSS 26 software. Firstly, the normality of the data was assessed using the Shapiro-Wilk test. Descriptive statistics were used to calculate the frequency, percentage, mean, standard deviation, minimum, and maximum. The paired-sample t-test was employed to compare the mean scores for each group before and after the intervention. Additionally, the independent-samples t-test was used to compare the mean scores between the two groups before and after the intervention. The chi-square test was utilized to determine the frequency of qualitative variables in both groups. Furthermore, ANCOVA was conducted to evaluate the effectiveness of the intervention while controlling for the pretest and the potential effects of some confounding variables. The significance level for the study was set at less than 0.05 (P < 0.05).