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Trial record 2 of 2 for:    RelevarEM

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. Identifier: NCT04244214
Recruitment Status : Not yet recruiting
First Posted : January 28, 2020
Last Update Posted : June 12, 2020
University of Oulu
University of Seville
Klinik Valens
Hospitales Nisa
Information provided by (Responsible Party):
Hospital Italiano de Buenos Aires

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.

Condition or disease Intervention/treatment
Multiple Sclerosis Fatigue Chronic Conditions, Multiple Other: More Stamina

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).

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

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
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.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Persons with Multiple Sclerosis

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT04244214

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Contact: Diego H Giunta, PhD +541149590200
Contact: Marina Alonso, MD +541149590200

Sponsors and Collaborators
Hospital Italiano de Buenos Aires
University of Oulu
University of Seville
Klinik Valens
Hospitales Nisa
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Study Director: Diego H Giunta, PhD RelevarEM
Study Director: Guido Giunti, PhD MoreStamina
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hospital Italiano de Buenos Aires Identifier: NCT04244214    
Other Study ID Numbers: 5497
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Italiano de Buenos Aires:
big data
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Chronic Conditions
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes