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| Name | Class |
|---|---|
| National MS Foundation, The Netherlands | UNKNOWN |
| Voeding Leeft | UNKNOWN |
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The LIMS study is an observational study that investigates the effectiveness of an online lifestyle program for patients with multiple sclerosis (MS). The patients will be monitored during 27 months, starting 3 months prior to the start of the lifestyle program.
This study aims to investigate the effect of an online lifestyle program on the impact of multiple sclerosis (MS) on daily functioning. MS patients will participate in the online lifestyle intervention of Voeding Leeft and will complete online questionnaires at 7 time-points: 3 months before the start of the intervention (run-in), before the start of the intervention (baseline), and 3, 6, 12, 18 and 24 months after the start of the intervention. A subsample (n=200) will also take part in measurements through mobile applications. The investigators hypothesize that the lifestyle program will reduce the impact of MS on the patients' daily functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with multiple sclerosis (MS) | Patients will participate in an online lifestyle program organized by Voeding Leeft, which consists of four main topics: diet, physical activity, relaxation and sleep. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention program "Leef! met MS" | Behavioral | The lifestyle program consists of a three-months intensive program, followed by a 21-months 'inspiration' program with occasional meetings. |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Sclerosis Impact Scale (MSIS-29) | Questionnaire that measures the impact of MS on their daily functioning | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| 12-item Short Form Health Survey (SF-12) | Questionnaire that measures quality of life | Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| EuroQol 5 Dimensions Questionnaire (EQ-5D) |
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Eligibility criteria to participate in the online lifestyle intervention:
Inclusion Criteria:
Exclusion Criteria:
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Patients with multiple sclerosis (MS) who signed up for the online lifestyle intervention of Voeding Leeft will be asked to participate in this observational study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brigit de Jong, Dr. | Contact | +31204442834 | b.dejong@amsterdamumc.nl | |
| Ilse Nauta, Drs. | Contact | i.nauta1@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Brigit de Jong | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, location VUmc | Recruiting | Amsterdam | North Holland | 1081 HV | Netherlands |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Questionnaire that measures quality of life |
| Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| BMI | BMI in kg/m^2 | Assessed at 7 time-points during 27 months Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| Waist circumference | Waist circumference in centimeters | Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| Bristol stool chart | Tool used to indicate stool type | Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| Medical Consumption Questionnaire (iMCQ) | Questionnaire that measures health-care consumption | Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| Hospital Anxiety and Depression Scale (HADS) | Questionnaire that measures symptoms of depression and anxiety | Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| Checklist Individual Strength-20-r (CIS-20) | Questionnaire that measures the level of fatigue | Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| Multiple Sclerosis Neuropyschological Screening Questionnaire - patient version (MSNQ-P) | Questionnaire that measures the level of subjective cognitive complaints | Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| Medical Outcomes Study Sleep Scale (MOS-ss) | Questionnaire that measures sleep quality | Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| Dutch Norm for Healthy Physical Activity (In Dutch: Nederlandse Norm voor Gezond Bewegen (NNGB)) | Questionnaire that measures the level of physical activity | Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| Perceived stress scale (PSS) | Questionnaire that measures the level of perceived stress | Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| iMTA Productivity Cost Questionnaire (iPCQ) | Questionnaire that measures work productivity and the frequency of sick leave | Assessed at 7 time-points during 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| Neurokeys keyboard app | Only in a subsample (n=200); Real-world keystroke dynamics collected by smartphone technology. | Continuous measures during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| MS sherpa app - Smartphone-adapted Symbol Digit Modalities Test (sSDMT) | Only in a subsample (n=200); Patients will use the MS sherpa app to perform a smartphone-adapted Symbol Digit Modalities Test (sSDMT) on their mobile phone. | Weekly tests during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| MS sherpa app - Smartphone-adapted two-minute walking test | Only in a subsample (n=200); Patients will use the MS sherpa app to perform a two-minute walking test outside. | Weekly tests during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| MS sherpa app - questionnaire | Only in a subsample (n=200); Patients will use the MS sherpa app to answer seven questions on a likert-scale (e.g. about pain, stress, energy, memory) within the mobile application. | Weekly questionnaire during a period of 27 months | Change over time between baseline and follow-up time-points will be compared to change over time between the run-in period and baseline. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |