Multiple sclerosis (MS) is one of the world’s most common neurologic disorders leading to severe disability in young adults. More than 2.3 million people live with MS in the world, with higher incidences in Northern Europe and in temperate climates [1]. MS is a chronic condition with high self-management needs [2] that require significant support [3-5] since the majority of self-management occurs at home [6]. MS symptoms range from simple visual disturbances and altered sensation to severe fatigue and cognitive problems with mobility issues [2]. Persons with MS can also go through stretches of periods in which symptoms worsen, called “attacks” or “relapses” [1,2]. Fatigue is the most common and disabling symptom of MS, affecting up to 80% of patients [7-12]. There seems to be some association between MS fatigue and environmental conditions such as the time of the day and weather [13] but it is still unknown how much of an influence these factors have. MS fatigue has a huge impact on quality of life [8,9] and socioeconomic status for persons with MS and is the major reason for early retirement [14]. As a result of MS, persons with MS are typically less active [15] and have reduced levels of physical activity [16-18].

Mobile health (mHealth) is the delivery of health care or health care–related services through the use of portable devices [19]. The use of mHealth software apps has grown in recent years, to the point where commercial app stores hold thousands of health care–related apps [20]. Several digital and remote communication technology apps have been developed for MS clinical monitoring and management, to complement traditional clinical approaches [21]. Wearable devices, including actigraphy, gyroscopes, and body temperature or heart rate monitors, have been used to obtain a more comprehensive assessment of different body functions and to monitor disability in persons with MS [22]. A recent review [21] showed that the use of apps for MS as complements to traditional in-clinic care can improve outcomes and increase access to care, disease information, and support. The use of mHealth could help persons with MS to be more active in their self-management, for example, by tracking adherence to treatment, changes in bladder and bowel habits, and activity and mood.

However, digital health technologies have low adoption rates by patients with chronic diseases, in part explained by an inappropriate fit of these technologies with patients’ daily lives and the high patient burden associated with digital self-monitoring [23]. Studies regarding the attitudes of persons with MS toward using smartphone apps highlight the benefits of tailoring apps to specific patient needs [24,25]. Further, involving patients and health care professionals in the design of technology is a need that has been often raised [26-32] and could be helpful in increasing adoption rates [33-35].

In previous studies, we explored available mHealth apps for persons with MS and found that only a handful exist [31,36]. This prompted the user-centered design (UCD) process of an mHealth solution specifically tailored for this target population called More Stamina.

UCD is a design philosophy that places the needs and characteristics of end users in the center of software design and development [37-39]. Through the use of UCD, solutions that are specific to the characteristics of the intended users are designed with higher acceptance and fewer user errors [38-40]. The overall process of UCD comprises the specification of the context of use (understand users and their characteristics and environment), specification of the requirements (identify the granular requirements and needs), production of solutions (start an iterative process of design and development), and evaluation (testing to find critical feedback on the product) [37,41].

The evaluation of usability entails a wide array of methodologies that vary in terms of research design, complexity, cost, and duration [42]. Different methods can be used to evaluate a system design on its usability, such as expert-based inspections and user-based testing [43]. Following UCD ensures that mHealth apps are more likely to meet end user needs and expectations [44,45].

More Stamina is a gamified task organization tool designed to help persons with MS manage their energy, to minimize the impact of fatigue on their daily life. The tool acts as a to-do list where users can input the tasks they want to accomplish that day in a simple manner (Figure 1). More Stamina is currently available in English, Spanish, Finnish, and German.

The overall concept is that a person’s energy is represented through a visual metaphor (progress bar) and a symbolic unit that quantifies the amount of estimated effort a given activity might take (Stamina Credits). Users start their day with 100 Stamina Credits and assign them to new activities for that day. As users go through their day and complete the activities, they mark them as done, and the system prompts them to assess whether their effort was underestimated, overestimated, or properly estimated. More Stamina keeps track of these answers as data points and starts analyzing and creating a trend for each activity (eg, “shopping”). Repeated use of More Stamina allows it to learn about the user’s habits, and once sufficient information is gathered on “shopping,” a recommendation feature starts reminding users of their own tendencies.

The app logs user activity through the in-built sensors of the device and is able to monitor the number of steps, walking pace, distances, and GPS positioning. Patient-reported outcomes are available and optional in More Stamina. Standardized tools such as the Fatigue Severity Scale [46] and Chalder Fatigue Scale [47] are loaded into the system. Usage statistics are gathered locally for each added activity to keep track and collect assessments; the user can choose to share these statistics to a secure server for analysis. Users have control as to which information to disclose and with whom, whether it’s personal, clinical, or treatment-related. Additionally, they can opt-in to send de-identified information for research purposes.

The More Stamina app was created following the UCD approach through iterative development, allowing continuous improvement of the app. The progress of the solution through the different phases of the UCD process is reported in our previous studies. The state of the practice of health apps for MS was studied through a systematic app review [31,36]. The needs, barriers, and facilitators of mHealth apps for persons with MS were explored using focus groups and interviews [25]. User profiles, or “personas,” were created to aid the design process [25,48], and the design process, prototyping, and initial usability testing have been described [49].

The work intended in this phase will assess the feasibility, acceptability, and usability of the mHealth solution with persons with MS (see Figure 2).

The overall study aims are to explore the feasibility, acceptability, and usability of More Stamina, a mobile app for fatigue self-management for persons with MS.

The specific objectives are to estimate adherence to the use of More Stamina; estimate the effect of More Stamina adherence on behavior change, measured through changes in the amount of activities and amount of estimated energy per activity; estimate the effect of adherence to the use of More Stamina on the perception of fatigue management; validate the value proposition of More Stamina; identify More Stamina user activity patterns of persons with MS; and identify factors associated with the use of More Stamina.

A mixed-methods, multicenter study will be used to assess the feasibility, acceptability, and usability of More Stamina. The study will take place during the third and fourth quarters of 2020 (Q3-Q4 2020) in 3 locations: Argentina, Spain, and Switzerland.

A longitudinal cohort pilot study will be conducted using a series of well-established standardized tools for user-based evaluations and surveys (see Standardized Tools). Participants’ background information regarding health information, quality of life, and familiarity with mobile technologies will be collected. Potential cultural differences will also be explored through qualitative approaches. System usage logs will quantify patient engagement with the system [50].

This study is part of a collaborative project between researchers and different institutions across the globe. The work will take place in 3 locations with local teams. Sessions will be conducted by a native language facilitator. Overall study coordination will be carried out by Dr. Guido Giunti from the University of Oulu as part of the More Stamina research project.

Persons with MS will be recruited from patient databases at HIBA, VNH, and Kliniken Valens and invited to participate in the study. Inclusion criteria will require each participant to be >18 years old, have received a confirmed MS diagnosis according to McDonalds criteria [51] at least 1 year prior to the study, have none to moderate physical disability (Expanded Disability Status Scale [EDSS] <6.5) at the time of recruitment, have no major cognitive or haptile impairment influencing the ability to use the app, be fluent in one of the languages in which More Stamina is available, and be the owner or user of a compatible smartphone device with internet access.

Exclusion criteria include refusal to participate, cognitive or physical impairment that prevents the use of mobile phones, and inability to attend the follow-up encounters.

This study seeks to enroll at least 20 patients that meet the criteria from each site for the longitudinal cohort study (total n=60). The sample size is an adequate number because of the methods used that provide extensive, detailed data [52].

The following is a description of the standardized tools that are used in this study. Language-appropriate and culturally validated versions will be used accordingly.

Persons with MS from each location will be invited to be part of the study and go through the process of informed consent where they will be briefed about the overall study and their rights as participants (see Ethical Considerations). After providing informed consent, participants will be part of a series of 4 workshops. Prospective monitoring will be carried out for 2 months for all participants at all sites, and daily measurements of More Stamina during that period will be considered.

Encounter 1 will be used to set up user accounts for participants, introduce the More Stamina solution, and install it on their smartphones. Monitoring will begin after the installation of More Stamina. All participants will complete the following standardized tools: EDSS, NeuroQoL, Chalder Fatigue Scale, eHeals, and System Usability Scale.

A subgroup of up to 5 participants per site (total n=15) will be selected for convenience to represent the main themes of this study: time since diagnosis (prolonged or recent), digital health literacy (expert user or beginner user), and disease burden (high or low). This subgroup will go through the think-aloud protocol by performing the specific scenarios and be interviewed about ease, utility, and perceived benefit. The sessions will be digitally audio recorded and video recorded, capturing on-screen navigation on screens.

There will be 3 face-to-face follow up meetings: day 15 (Encounter 2), day 30 (Encounter 3), and at the end of the follow-up at day 60 (Encounter 4). In these meetings, feedback will be obtained on the use of the More Stamina app regarding its functionality, usability problems, daily use, and information concerning disability, quality of life, and adherence. The overall study flow that will be replicated in each site is shown in Figure 3.

Access to personal information will be restricted to the investigators of the study, health authorities, the Research Ethics Committee, and the monitors and auditors of the study. They will be subject to the duty of secrecy inherent to their profession, when necessary, to verify the data and procedures of the study, but always maintaining the confidentiality of the same according to the current legislation. Participants may exercise their rights of access, rectification, cancellation, and opposition of data according to the European Union General Data Protection Regulations [68].

The information and personal data of the participants will be kept in a completely confidential form with all the rigor of the law. Participants will be asked to not use any names during group discussions. Reports of study results will not include any identifying information. The paper questionnaires used will be digitized. The audio recordings of the group discussions will be typed and kept in secure servers at the University of Oulu. After the transcriptions are finished, the audio recordings will be destroyed. The typed transcripts will remain on password-protected computers, and any hard copy will be kept in a closed filing cabinet. Only members of the research team will be able to listen to the recordings or read the typed versions.

The ethical research guidelines of the University of Oulu [69] and University of Seville [70] will be followed. Ethical approval will be obtained to ensure that the research is done in accordance with the Declaration of Helsinki and in line with the current local legislations from the respective authorities: HIBA’s Institutional Review Board (Argentina), the Ethics Committee of the Regional Ministry of Health of the Government of Andalusia (Spain), and the Swiss Ethics Committee on Research Involving Humans (Switzerland). The study has been registered in ClinicalTrials.gov with the identifier NCT04244214.

The participants will be informed about the nature of the research project; the reasons for their participation; risks, benefits, and alternatives associated with the research; and their rights as research subjects before agreeing to participate. Steps will be taken to ensure that data gathered from participants will be kept under strict security, anonymity, and privacy.

This protocol presents the work intended to take place to assess the feasibility, acceptability, and usability of a fatigue management mHealth solution for persons with MS.

Persons with MS have a different attitude than other people towards physical activity [18] and are typically less active than healthy persons [15]. The proposed approach of More Stamina for fatigue management is in line with common approaches in energy conservation education programs and fatigue management for MS [71,72]. The goal is to help the patient save energy through the implementation of different strategies such as work simplification or the use of task prioritization.

By tracking and collecting use and contextual information, the present study will also help to understand underlying factors and causes for MS fatigue.

The goal of this pilot study is to further our understanding of the potential issues and challenges that will be used as the foundations for a larger randomized control study.

It is possible that the differences between the patient group who participated in the UCD and the target groups of this study are significant enough that there is a preference mismatch. For example, the importance of fatigue management could vary depending on cultural factors or adherence, or interest could even be radically different depending on economic factors. This is expected, and understanding potential differences is part of the aims of the study. Finally, the nature of the study does not allow the assessment of health outcomes due to the lack of randomized exposure and monitoring period. Such explorations will be the subject of future studies.