Study to Evaluate the Usability of Introducing Integrated Digital Solutions Into Clinical Practice and the Value of Their Use in the Medical Care of Patients With Multiple Sclerosis (MS)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 500
- 试验地点
- 11
- 主要终点
- HCPs: Median of the System Usability Scale (SUS) Score Reported by Radiologists and Neurologists at Month 6
研究概览
简要总结
The main purpose of this study is to assess the usability and value of the multiple sclerosis (MS) care management platform in terms of improved monitoring of people with MS (pwMS) in clinical practice.
This is a two-year prospective data collection study with additional data collection at baseline evaluating medical practice over a period of at least one year before the introduction of the MS care management platform.
详细描述
The MS care management platform consists of:
A) icobrain ms, a cloud-based artificial intelligence (AI) solution to quantify brain volume and brain abnormalities and changes thereof on magnetic resonance imaging (MRI) scans and thereby providing insights into subclinical changes during disease progression in MS.
B) icompanion ms, which consists of i) A free participant mobile application (app) and website to keep track of participant reported health and medications and prepare participants for the next consultation.
ii) A web portal for healthcare professionals (HCPs), which is accessible via web browser. The MS care team will be able to access the participants' data entered via the participant app (active linking of systems by the participant required), as well as their participants' MRI images and icobrain ms volumetric brain reports automatically imported by the hospital picture archiving and communications system (PACS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comply with the study protocol, including having a smartphone and being able and willing to access the icompanion ms patient app on a regular basis. To use all functionalities of the icompanion ms patient app, the user's smartphone must comply with the minimum system requirements (Android version 5.0 or above, iOS version 11 or above)
- •Have a valid email address (for registration of icompanion ms)
- •Have a definite diagnosis of RRMS
- •Time since MS diagnosis ≥1 year
- •Medical history recorded for at least 1 year before enrollment
- •Expanded Disability Status Scale (EDSS) <5.5
排除标准
- •Any contra-indications to using icompanion ms patient app or website, as per the investigator's discretion
- •Inability to complete an MRI
- •Currently involved in an interventional trial
- •Diagnosis of progressive MS (primary progressive multiple sclerosis [PPMS] or secondary progressive multiple sclerosis [SPMS])
研究组 & 干预措施
People with RRMS
Participants with relapsing-remitting multiple sclerosis (RRMS) will have to complete various questionnaire from which data will be collected for patient-reported outcomes (PROs) using the icompanion patient app and the HCPs will complete various questionnaires using the icompanion HCP portal.
干预措施: MS Care Platform (icobrain ms and icompanion ms) (Device)
结局指标
主要结局
HCPs: Median of the System Usability Scale (SUS) Score Reported by Radiologists and Neurologists at Month 6
时间窗: Month 6
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: \<51=awful; 51-68=poor; 68=okay; 68-80.3=good; \> 80.3=excellent; 100=best imaginable score.
HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 12
时间窗: Month 12
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: \<51=awful; 51-68=poor; 68=okay; 68-80.3=good; \> 80.3=excellent; 100=best imaginable score.
Participants: Median Score of the mHealth App Usability Questionnaire (MAUQ) [MAUQ_E (Ease of Use) MAUQ_I (Interface and Satisfaction)] at Baseline
时间窗: Baseline
MAUQ\_E and MAUQ\_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ\_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ\_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 24
时间窗: Month 24
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: \<51=awful; 51-68=poor; 68=okay; 68-80.3=good; \> 80.3=excellent; 100=best imaginable score.
Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 12
时间窗: Month 12
MAUQ\_E and MAUQ\_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ\_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ\_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 24
时间窗: Month 24
MAUQ\_E and MAUQ\_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ\_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ\_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by SSIs at Month 24
时间窗: Baseline to Month 24
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by Semi-structured Interviews (SSIs) at Month 6
时间窗: Baseline to Month 6
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by SSIs at Month 12
时间窗: Baseline to Month 12
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
HCPs: Median of the System Usability Scale (SUS) Score Reported by Radiologists and Neurologists at Month 6
时间窗: Month 6
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: \<51=awful; 51-68=poor; 68=okay; 68-80.3=good; \> 80.3=excellent; 100=best imaginable score.
HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 12
时间窗: Month 12
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: \<51=awful; 51-68=poor; 68=okay; 68-80.3=good; \> 80.3=excellent; 100=best imaginable score.
HCPs: Median of the SUS Score Reported by Radiologists and Neurologists at Month 24
时间窗: Month 24
SUS is a validated scale that assesses subjective usability of a system, or, in this case, the MS care management platform. The SUS consists of a 10-item questionnaire with five response options ranging from Strongly agree (5) to Strongly disagree (1). The items scores are converted into a score from 0 (negative) to 100 (positive). A score of ≥50 indicates that the MS care management platform is acceptable, and a score above 68 is considered above average. The final SUS score is not a percentile or a percentage and the SUS acceptability guidelines on how to interpret the score are: \<51=awful; 51-68=poor; 68=okay; 68-80.3=good; \> 80.3=excellent; 100=best imaginable score.
Participants: Median Score of the mHealth App Usability Questionnaire (MAUQ) [MAUQ_E (Ease of Use) MAUQ_I (Interface and Satisfaction)] at Baseline
时间窗: Baseline
MAUQ\_E and MAUQ\_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ\_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ\_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 12
时间窗: Month 12
MAUQ\_E and MAUQ\_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ\_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ\_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
Participants: Median Score of the MAUQ (MAUQ_E and MAUQ_I) at Month 24
时间窗: Month 24
MAUQ\_E and MAUQ\_I are subscales of a validated self-report survey (MAUQ) in which participants report how easy the app (icompanion MS patient app) was to use and rate their satisfaction with the user interface of the app. MAUQ\_E consists of a 5-item questionnaire with seven response options ranging from Strongly agree to Strongly disagree. Ease of use scores range from 5 to 35 with higher scores indicating greater ease of use. MAUQ\_I consists of a 7-item questionnaire with seven response options; from Strongly agree to Strongly disagree. Interface and satisfaction scores range from 7 to 49 with higher scores indicating greater satisfaction.
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by Semi-structured Interviews (SSIs) at Month 6
时间窗: Baseline to Month 6
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by SSIs at Month 12
时间窗: Baseline to Month 12
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
Change From Baseline in Perception of Disease Worsening by HCPs, Assessed by SSIs at Month 24
时间窗: Baseline to Month 24
To assess the change in perception of disease worsening by the HCPs, two versions of the SSIs are available, one version is for radiology and the other for neurology. The HCPs are required to answer a set of 3 questions with 6 response options ranging from strongly disagree to strongly agree and also select the reasons for agreeing/disagreeing from the options listed. If HCPs agree, they can select between aspects of the disease activity/progression for which the system provides an increased ability to detect changes. The questionnaire also includes an item with a yes/no response. A scale ranging from 1 to 6 will be attributed to these responses (with 1 being strongly disagree and 6 being strongly agree). The higher the score, the higher the impact of the tools in the perception of disease worsening.
次要结局
- Time in Days Needed for the Successful Installation and Integration of all Components in the MS Care Management Platform(Baseline)
- Change From Baseline in Time Needed for MRI Review, Assessed by SSIs of Radiologists(Baseline, 6, 12 and 24 months)
- Change From Baseline in Time Needed for Visit Preparation, Assessed by SSIs of Neurologists(Baseline, 6, 12 and 24 months)
- Number of Participants at Each Study Center That Register for the icompanion ms Patient app(Up to 24 months)
- Number of HCPs at Each Study Center Registered on the MS Care Management Platform(Up to 24 months)
- Factors Influencing HCPs Adherence Measured by SSIs(Baseline, 6, 12 and 24 months)
- Average Number of Activities in the icompanion ms Patient app per Patient per Month(Up to 24 months)
- Change From Baseline in Health Literacy Assessed by the Health Literacy Questionnaire (HLQ)(Baseline, 12 and 24 months)
- Factors Influencing HCPs Adoption to MS Care Management Platform Measured by SSIs(Baseline, 6, 12 and 24 months)
- Number of MRI Scans per Study Center Analyzed With icobrain ms(Baseline, 6, 12, 18 and 24 months)
- Reasons for not Registering for icompanion ms Patient app as Described by the HCP Through the icompanion ms HCP Portal(Up to 24 months)
- Change From Baseline in Participant Autonomy Assessed by the Patient Activation Measure® 13 (PAM13)(Baseline, 12 and 24 months)
- Change From Baseline in Medication Adherence, Assessed by the Morisky Medication Adherence Scale (MMAS)(Baseline, 12 and 24 months)
- Level of Engagement on Platform Assessed Monthly by the Number of Logins and Time Spent on Individual Portal Pages in the HCP Portal(Up to 24 months)
- Number of Participants Using the icompanion ms Patient app With at Least 2 Activities Within 2 Months, Assessed per Month(Baseline up to 2 months of enrollement (Up to approximately 12 months))
- Number of Participants That Stop Using the icompanion ms Patient app (no Activity for More Than 4 Months), Assessed per Month(Up to 24 months)
- Reasons for not Using the icompanion ms Patient app Regularly as Described by HCP Through the icompanion ms HCP Portal(Up to 24 months)