Multiple SclerosisNCT04244214
Pilot Study for the Evaluation of the More Stamina in Persons With Multiple Sclerosis
An observational study of Multiple Sclerosis and Fatigue, run by Hospital Italiano de Buenos Aires at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis, Fatigue, Chronic Conditions, Multiple
- What is being tested?
- More Stamina
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2023to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with Multiple Sclerosis
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis, Fatigue, Chronic Conditions, Multiple
- Being tested
- More Stamina
- Keywords
- eHealth, mHealth, gamification
- Medical subject headings
- Multiple Sclerosis, Fatigue, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| More Stamina users | This group of patients will use the app for 60 days and all information about utilization will be recorded Receives: Other: More Stamina |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1, Day 15, Day 30, and Day 60.
Secondary outcomes (2)
Association Between User Categories and Fatigue Severity Scores
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.
Measured: Over the 60-day study period.
Association Between User Categories and Health-Related Quality of Life Scores
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.
Measured: Over the 60-day study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Jan 2023
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital, University of Oulu, Finland
- Responsible party
- Principal investigator, Guido Giunti, University of Oulu
- Investigators
- Diego H Giunta, PhD, Study director, RelevarEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244214
- Sponsor's protocol ID
- 5497
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2020
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29500159Giunti 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.
PubMed 29426814Giunti 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.
PubMed 29792295Giunti 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.
PubMed 32749995
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Evaluation of the More Stamina Mobile Application for Fatigue Management in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04244214
- Acronym / sponsor ID
- 5497
- Conditions
- Multiple Sclerosis, Fatigue, Chronic Conditions, Multiple
- Keywords
- eHealth, mHealth, gamification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Oulu University Hospital, University of Oulu, Finland
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| More Stamina users | – | Other: More StaminaThis group of patients will use the app for 60 days and all information about utilization will be recorded |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with Multiple Sclerosis
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| More StaminaMore 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. | Other | More Stamina users |
Primary outcome
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.
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.
2 secondary outcomes
Association Between User Categories and Fatigue Severity Scores
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Background: PubMed 29500159Giunti 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.
- Background: PubMed 29426814Giunti 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.
- Background: PubMed 29792295Giunti 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.
- Derived from this study: PubMed 32749995Giunti 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.
- More Stamina WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego H Giunta, PhD study director
RelevarEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Fatigue, run by Hospital Italiano de Buenos Aires at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
App Engagement Patterns (time frame: Over the 60-day study period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04244214, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.