NCT04244214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
2.9 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 21, 2020

Last Update Submit

January 8, 2025

Conditions

Multiple SclerosisFatigueChronic Conditions, Multiple

Keywords

eHealthmHealthgamification

Outcome Measures

Primary Outcomes (2)

  • App Engagement Patterns

    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

    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 Outcomes (2)

  • Association Between User Categories and Fatigue Severity Scores

    Over the 60-day study period.

  • Association Between User Categories and Health-Related Quality of Life Scores

    Over the 60-day study period.

Study Arms (1)

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

Interventions

More StaminaOTHER

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.

More Stamina users

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Persons with Multiple Sclerosis

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oulu University Hospital

Oulu, Finland

Location

Related Publications (4)

  • 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.

    PMID: 29500159BACKGROUND

  • 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.

    PMID: 29426814BACKGROUND

  • 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.

    PMID: 29792295BACKGROUND

  • 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.

    PMID: 32749995DERIVED

Related Links

MeSH Terms

Conditions

Multiple SclerosisFatigueMultiple Chronic Conditions

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsChronic DiseaseDisease AttributesPathologic Processes

Study Officials

  • Diego H Giunta, PhD

    RelevarEM

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 28, 2020

Study Start

January 1, 2023

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

FI(1)