Pilot Study for the Evaluation of the More Stamina in Persons With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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Multiple sclerosis (MS) is one of the world's most common neurologic disorders of the young adults leading to severe disability. Fatigue is one of most common symptoms that persons with MS experience, having significant impact on their quality of life and limiting their activity levels. Self-management strategies are used to support them in the care of their health. Mobile health (mHealth) solutions are a way to offer persons with chronic conditions tools to successfully manage their symptoms and problems. User-centered design (UCD) is a design philosophy that proposes placing end-users' needs and characteristics in the center of software design and development and involving users early in the different phases of the software life cycle. More Stamina is an mHealth solution created following UCD principles to help persons with MS manage their fatigue. 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 first and second quarters of 2020 (Q3-Q4 2020) in three locations: Argentina, Spain and Switzerland. A longitudinal cohort study will take place, along with think-aloud protocols, open-ended interviews and short answer questionnaires will be used. Persons with MS will be recruited from the different locations. This study seeks to enroll at least 20 patients that meet the criteria from each site for the longitudinal cohort study (total N=60).

Official Title
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Pilot Study for the Evaluation of the More Stamina Mobile Application for Fatigue Management in Persons With Multiple Sclerosis

Conditions
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Multiple Sclerosis, Fatigue, Chronic Conditions, Multiple

Intervention / Treatment
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* Other: More Stamina


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be over 18 years old; have a confirmed MS diagnosis (including secondary, relapsing and progressive MS) for at least 1 year, have none to moderate physical disability (EDSS < 6.5) at the time of recruiting; no major cognitive or haptile impairment influencing the ability to use the app; own a compatible smartphone device; Spanish language reading comprehension. Exclusion Criteria: Refusal to participate or the informed consent process; Objective cognitive impairment that hinders the use of mobile applications; Physical or cognitive impossibility to use the visual interface of mobile applications; difficulties in access or availability for full attendance at the 3 workshops of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| More Stamina users<br>This group of patients will use the app for 60 days and all information about utilization will be recorded | Other: More Stamina<br>* More Stamina is a gamified task organization tool designed to help persons with MS manage their energy, to minimize the impact of fatigue in their day to day life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobile app adherence | Adherence to app use calculated as the porcentage of days that each user used the MoreStamina app divided by the total 60 days of follow up | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eHealth, mHealth, gamification, big data