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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04244214
• Other study ID #: 5497
• Status: Not yet recruiting
• Start date: August 21, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: June 2020
• Source: Hospital Italiano de Buenos Aires
• Contact: Diego H Giunta, PhD
• Phone: +541149590200
• Email: diego.giunta[@]hiba.org.ar
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Conditions, Multiple
• Fatigue
• Multiple Chronic Conditions
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• More Stamina
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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires	Hospitales Nisa, Klinik Valens, University of Oulu, University of Seville

References & Publications (3)

Giunti G, Guisado Fernández 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   More Stamina digital health solution