Multiple Sclerosis, Chronic ProgressivePIANCT03114293
Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS
A study testing Smartphone App in people with Multiple Sclerosis, Chronic Progressive, run by Universitätsklinikum Hamburg-Eppendorf.
Trial summary
Due to their ubiquitary distribution, smartphones might serve as an easy way/ possibility to use feedback mechanism in an app-based intervention program to increase physical activity in Multiple Sclerosis (MS) patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Chronic Progressive
- What is being tested?
- Smartphone App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 30 May 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- progressive MS
Who cannot join
- other major health disorder
- EDSS above 6
About this study
Due to their ubiquitary distribution, smartphones might serve as an easy way/ possibility to use feedback mechanism in an app-based intervention program to increase physical activity in Multiple Sclerosis (MS) patients. Internet based cognitive-behavioral interventions have been explored as effective in the last years. In addition, smartphone-based mobility assessment and intervention might be a promising approach in other MS types and for real-life mobility assessment in observational and interventional trials. The aim is to investigate the impact of a smartphone based information and feedback program on physical activity in a 3 months, randomised waiting-group controlled trial of 40 progressive MS patients.
- Conditions
- Multiple Sclerosis, Chronic Progressive
- Being tested
- Smartphone App
- Keywords
- Physical activity, Mobility
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone AppBehavioural
The app includes an EBPI and physical activity feedback
| Study group | Role | What they receive |
|---|---|---|
| Waiting group | No intervention | Waiting group |
| Smartphone intervention | Experimental | Smartphone bases behavioural intervention Receives: Behavioral: Smartphone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of responders
Rate of responders as defined by a 20% increase of steps or 20% increase in physical activity as measured with the actigraph
Measured: 3 Months
Secondary outcomes (6)
Physical activity: total activity
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
Measured: 3 Months
Physical activity: distance per day
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
Measured: 3 Months
Physical activity: number of steps per day
Physical activity and real-life mobility: 1-week accelerometry (actigraph)
Measured: 3 Months
Questionnaires on quality of life (QoL, HAQUAMS)
Disease specific quality of life questionnaire
Measured: 3 Months
Questionnaires on activities of daily living (ADL)
Frenchay activity index
Measured: 3 Months
Questionnaires on physical activity
Godin Leisure time
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 Apr 2016
- Primary completion30 May 2017 (estimated)
- Study completion30 May 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Chronic ProgressiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Short, randomised waiting-group controlled explorative studies of a behavioural intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan-Patrick Stellmann, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114293
- Sponsor's protocol ID
- inims-pia
- Acronym
- PIA
- Status last verified
- May 2017
- First submitted
- 31 Mar 2017
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS
- ClinicalTrials.gov ID
- NCT03114293
- Acronym / sponsor ID
- PIA / inims-pia
- Conditions
- Multiple Sclerosis, Chronic Progressive
- Keywords
- Physical activity, Mobility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 May 2017 (estimated)
- Study completion
- 30 May 2017 (estimated)
- First posted
- 14 Apr 2017 (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.
Due to their ubiquitary distribution, smartphones might serve as an easy way/ possibility to use feedback mechanism in an app-based intervention program to increase physical activity in Multiple Sclerosis (MS) patients. Internet based cognitive-behavioral interventions have been explored as effective in the last years. In addition, smartphone-based mobility assessment and intervention might be a promising approach in other MS types and for real-life mobility assessment in observational and interventional trials. The aim is to investigate the impact of a smartphone based information and feedback program on physical activity in a 3 months, randomised waiting-group controlled trial of 40 progressive MS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Short, randomised waiting-group controlled explorative studies of a behavioural intervention.
| Arm | Type | Receives |
|---|---|---|
| Waiting group | No intervention | –Waiting group |
| Smartphone intervention | Experimental | Behavioral: Smartphone AppSmartphone bases behavioural intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- progressive MS
Key exclusion criteria (2 listed)
- other major health disorder
- EDSS above 6
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 |
|---|---|---|
| Smartphone AppThe app includes an EBPI and physical activity feedback | Behavioural | Smartphone intervention |
Primary outcome
Rate of responders
Time frame: 3 Months
Rate of responders as defined by a 20% increase of steps or 20% increase in physical activity as measured with the actigraph
6 secondary outcomes
Physical activity: total activity
Time frame: 3 Months
Physical activity: distance per day
Time frame: 3 Months
Physical activity: number of steps per day
Time frame: 3 Months
Questionnaires on quality of life (QoL, HAQUAMS)
Time frame: 3 Months
Questionnaires on activities of daily living (ADL)
Time frame: 3 Months
Questionnaires on physical activity
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone App in people with Multiple Sclerosis, Chronic Progressive, run by Universitätsklinikum Hamburg-Eppendorf.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Rate of responders (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2017.