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

January 8, 2025 updated by: Guido Giunti, 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

Completed

Conditions

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 study was used to assess the feasibility, acceptability, and usability of More Stamina. The study took place between January and March of 2023 in Finland. A longitudinal cohort study took take place, along with think-aloud protocols, open-ended interviews and short answer questionnaires. The study enrolled 20 persons with MS that met the criteria who utilized the More Stamina solution for 60 days.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

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

Study Locations

  • Finland
      • Oulu, Finland
        • Oulu University Hospital

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

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;

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 encounters 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
App Engagement Patterns
Time Frame: Over the 60-day study period.
Participants' engagement with the "More Stamina" app, categorized into power, regular, and light users based on daily session averages. Engagement analyzed through session frequency, timing, and activity types.
Over the 60-day study period.
Qualitative Insights into Usability and Barriers
Time Frame: Day 1, Day 15, Day 30, and Day 60.
Insights into usability challenges and facilitators were gathered using think-aloud protocols and semi-structured interviews. Common themes, including cognitive load, technical issues, and emotional responses, were analyzed.
Day 1, Day 15, Day 30, and Day 60.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association Between User Categories and Fatigue Severity Scores
Time Frame: Over the 60-day study period.
User categories (power, regular, and light users) were determined by average daily app sessions. Fatigue severity was measured using the Fatigue Severity Scale (FSS), with scores ranging from 1 (no fatigue) to 7 (severe fatigue). The relationship between user engagement categories and FSS scores was analyzed using Spearman's rank-order correlation and linear regression models.
Over the 60-day study period.
Association Between User Categories and Health-Related Quality of Life Scores
Time Frame: Over the 60-day study period.
User categories defined by app engagement patterns (power, regular, and light users). HRQoL was assessed using the 15D instrument, with scores ranging from 0 (death) to 1 (full health). Scores were inverted (1 - HRQoL score) to align with worse QoL. Correlations and regression models explored associations between user categories and QoL.
Over the 60-day study period.

Collaborators and Investigators

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

Sponsor

Hospital Italiano de Buenos Aires

Collaborators

Oulu University Hospital
University of Oulu, Finland

Investigators

  • Study Director: Diego H Giunta, PhD, RelevarEM

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.

General Publications

Helpful Links

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 (Actual)

January 1, 2023

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

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)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

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)?

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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