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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45289

Enrollment

130

Registered

2017-04-20

Start date

2017-05-31

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

demyelinating diseas Multiple Sclerosis

Interventions

Multiple Sclerosis

Selfefficacy

Selfmonitoring devices

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)