Clinical trial NCT04244214: Pilot Study for the Evaluation of the More Stamina in Persons With Multiple Sclerosis
Official title: Pilot Study for the Evaluation of the More Stamina Mobile Application for Fatigue Management in Persons With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Fatigue
Chronic Conditions, Multiple
Keywords: eHealth
mHealth
gamification
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: University of Oulu, Finland
First posted: 2020-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with Multiple Sclerosis

Brief summary: 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: 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 study was used to assess the feasibility, acceptability, and usability of More Stamina. The study took place between January and March of 2023 in Finland. A longitudinal cohort study took take place, along with think-aloud protocols, open-ended interviews and short answer questionnaires. The study enrolled 20 persons with MS that met the criteria who utilized the More Stamina solution for 60 days.

Eligibility criteria: 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;

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 encounters of the study.

Primary outcomes:
measure: App Engagement Patterns
timeFrame: Over the 60-day study period.
measure: Qualitative Insights into Usability and Barriers
timeFrame: Day 1, Day 15, Day 30, and Day 60.
Secondary outcomes:
measure: Association Between User Categories and Fatigue Severity Scores
timeFrame: Over the 60-day study period.
measure: Association Between User Categories and Health-Related Quality of Life Scores
timeFrame: Over the 60-day study period.
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: RelevarEM
name: Diego H Giunta, PhD
role: STUDY_DIRECTOR
References:
citation: Giunti G, Mylonopoulou V, Rivera Romero O. More Stamina, a Gamified mHealth Solution for Persons with Multiple Sclerosis: Research Through Design. JMIR Mhealth Uhealth. 2018 Mar 2;6(3):e51. doi: 10.2196/mhealth.9437.
citation: Giunti G, Kool J, Rivera Romero O, Dorronzoro Zubiete E. Exploring the Specific Needs of Persons with Multiple Sclerosis for mHealth Solutions for Physical Activity: Mixed-Methods Study. JMIR Mhealth Uhealth. 2018 Feb 9;6(2):e37. doi: 10.2196/mhealth.8996.
citation: Giunti G, Guisado Fernandez E, Dorronzoro Zubiete E, Rivera Romero O. Supply and Demand in mHealth Apps for Persons With Multiple Sclerosis: Systematic Search in App Stores and Scoping Literature Review. JMIR Mhealth Uhealth. 2018 May 23;6(5):e10512. doi: 10.2196/10512.
citation: Giunti G, Rivera-Romero O, Kool J, Bansi J, Sevillano JL, Granja-Dominguez A, Izquierdo-Ayuso G, Giunta D. Evaluation of More Stamina, a Mobile App for Fatigue Management in Persons with Multiple Sclerosis: Protocol for a Feasibility, Acceptability, and Usability Study. JMIR Res Protoc. 2020 Aug 4;9(8):e18196. doi: 10.2196/18196.