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Completed

NCT Number: NCT04244214

Pilot Study for the Evaluation of the More Stamina 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Conditions, Multiple Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Fatigue Immune System Diseases Multiple Chronic Conditions Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oulu University Hospital

Oulu, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

More Stamina

Other

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hospital Italiano de Buenos Aires

Other

Collaborators

  • Oulu University Hospital
  • University of Oulu, Finland

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2020
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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