- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04244214
Pilot Study for the Evaluation of the More Stamina in Persons With Multiple Sclerosis
Pilot Study for the Evaluation of the More Stamina Mobile Application for Fatigue Management in Persons With Multiple Sclerosis
Study Overview
Status
Intervention / Treatment
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 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).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Diego H Giunta, PhD
- Phone Number: +541149590200
- Email: diego.giunta@hiba.org.ar
Study Contact Backup
- Name: Marina Alonso, MD
- Phone Number: +541149590200
- Email: marina.alonso@hiba.org.ar
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
More Stamina users
This group of patients will use the app for 60 days and all information about utilization will be recorded
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobile app adherence
Time Frame: 60 days
|
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
|
Collaborators and Investigators
Investigators
- Study Director: Diego H Giunta, PhD, RelevarEM
- Study Director: Guido Giunti, PhD, MoreStamina
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5497
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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