MS Self - A study on the validity, sensitivity and user experience of new mobile selfmonitoring devices voor people with Relapsing Remitting Multiple Sclerosis

Completed

Conditions: demyelinating diseas
Multiple Sclerosis
10003816
10012303

Registration Number: NL-OMON45289

Lead Sponsor: ationaal MS Fonds

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

1) Willing and able to participate in the proposed research
2) Williing and able to use their smartphone for this research. Smartphones included in this study are: Iphone version 5 (or higher) or Android version 6 (or higher)
3) Age 20 to 50 years old;For participation of people with MS we include the following additional criteria:
4) Diagnosis RRMS more than 1 year
5) EDSS between 1.5 and 6.5

Exclusion Criteria

Group I and II of the control participants will be matched on age, gender and level of education to the people with MS. During recrutement this may lead us to exclude certain participants from enrolling in the study to ensure the matching.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes are whether the results from three tests that were recently<br /><br>developed for the smartphone:<br /><br>(1) the smartphone Symbol Digit Modalities Test (sSDMT),<br /><br>(2) the smartphone Two-Minute Walking Test (s2MWT), and<br /><br>(3) the smartphone Walking Balance Test (sWBT)<br /><br>match the results of the existing tests: the SDMT, the 2MWT and the<br /><br>Timed-get-Up and Go Test (TUG), respectively.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundaire outcomes are whether the Fitbit can be used for differentiating<br /><br>between people with MS and control participants. We study whether:<br /><br>1) thee Fitbit data (a) heartrate, (b) number of steps per day and (c) the<br /><br>number of hours sleep are different between people with MS and control<br /><br>participants;<br /><br>2) whether Fitbit data on getting up during the night match a hand-written<br /><br>bathroom logbook. This provides insight into whether the Fitbit can be used to<br /><br>measure nycturia (getting up during the night for bathroom visits), which many<br /><br>people with MS have to deal with. As a reference we use the Nocturia<br /><br>Quality-of-Life (nQOL) questionnaire.<br /><br><br /><br>Finally, semi-structured interviews with a subset of participants, is used to<br /><br>assess user experience and expectations.</p><br>