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

NCT ID: NCT04244214

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis Fatigue Chronic Conditions, Multiple

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

More Stamina users

This group of patients will use the app for 60 days and all information about utilization will be recorded

More Stamina

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Oulu, Finland

UNKNOWN

Sponsor Role collaborator

Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Guido Giunti

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Diego H Giunta, PhD

Role: STUDY_DIRECTOR

RelevarEM

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oulu University Hospital

Oulu, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

References

Explore related publications, articles, or registry entries linked to this study.

Giunti G, Mylonopoulou V, Rivera Romero O. More Stamina, a Gamified mHealth Solution for Persons with Multiple Sclerosis: Research Through Design. JMIR Mhealth Uhealth. 2018 Mar 2;6(3):e51. doi: 10.2196/mhealth.9437.

Reference Type BACKGROUND
PMID: 29500159 (View on PubMed)

Giunti G, Kool J, Rivera Romero O, Dorronzoro Zubiete E. Exploring the Specific Needs of Persons with Multiple Sclerosis for mHealth Solutions for Physical Activity: Mixed-Methods Study. JMIR Mhealth Uhealth. 2018 Feb 9;6(2):e37. doi: 10.2196/mhealth.8996.

Reference Type BACKGROUND
PMID: 29426814 (View on PubMed)

Giunti G, Guisado Fernandez E, Dorronzoro Zubiete E, Rivera Romero O. Supply and Demand in mHealth Apps for Persons With Multiple Sclerosis: Systematic Search in App Stores and Scoping Literature Review. JMIR Mhealth Uhealth. 2018 May 23;6(5):e10512. doi: 10.2196/10512.

Reference Type BACKGROUND
PMID: 29792295 (View on PubMed)

Giunti G, Rivera-Romero O, Kool J, Bansi J, Sevillano JL, Granja-Dominguez A, Izquierdo-Ayuso G, Giunta D. Evaluation of More Stamina, a Mobile App for Fatigue Management in Persons with Multiple Sclerosis: Protocol for a Feasibility, Acceptability, and Usability Study. JMIR Res Protoc. 2020 Aug 4;9(8):e18196. doi: 10.2196/18196.

Reference Type DERIVED
PMID: 32749995 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5497

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.