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

June 10, 2020 updated by: Hospital Italiano de Buenos Aires

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

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.

Study Overview

Status

Unknown

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

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Persons with Multiple Sclerosis

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Diego H Giunta, PhD, RelevarEM
  • Study Director: Guido Giunti, PhD, MoreStamina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 21, 2020

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

January 21, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

June 12, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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