Pilot Study for the Evaluation of the More Stamina in Persons With Multiple Sclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04244214|
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis Fatigue Chronic Conditions, Multiple||Other: More Stamina|
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 :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Pilot Study for the Evaluation of the More Stamina Mobile Application for Fatigue Management in Persons With Multiple Sclerosis|
|Estimated Study Start Date :||August 21, 2020|
|Estimated Primary Completion Date :||October 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
More Stamina users
This group of patients will use the app for 60 days and all information about utilization will be recorded
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04244214
|Contact: Diego H Giunta, PhDemail@example.com|
|Contact: Marina Alonso, MDfirstname.lastname@example.org|
|Study Director:||Diego H Giunta, PhD||RelevarEM|
|Study Director:||Guido Giunti, PhD||MoreStamina|