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| ID | Type | Description | Link |
|---|---|---|---|
| K24AT012644 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The Me Time MS Application was designed to enable self-administration of acupressure. Two forms of acupressure - either "relaxing" or "stimulating" protocols - are administered through the Me Time MS app.
The goal of this study is to assess the usability of the Me Time MS app in a sample of 10 adults with multiple sclerosis (MS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relaxing Self-Acupressure | Experimental | Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks. |
|
| Stimulating Self-Acupressure | Experimental | Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-guided smartphone application for relaxing acupressure | Behavioral | Relaxing Acupressure entails applying pressure with either a finger, pencil, or similar object to acupressure points. For the relaxing protocol, there is a total of 9 acupoints (1 unilateral and 4 bilateral). Each point will be stimulated for 3 minutes, yielding a total treatment time of 27 minutes each day. The acupoints are:
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Perception of Me Time MS App Usability | Qualitative descriptions of positive, negative, and neutral aspects of usability of the Me Time MS app, gathered through one-on-one, open-ended interviews after 6 weeks of access to the app. Results reflect the total number of comments across all participants that were provided for each category. Participants could submit multiple types of comments. | Up to 2 weeks after the 6-week app usage period ended |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Scale (SUS) Adapted for the MeTime MS App | SUS is a custom, 10-item survey to assess the participant's perception of the usability of the MeTime MS app. Possible total score ranges from 0 (lowest usability) to 40 (highest usability). | Up to 2 weeks after the 6-week app usage period ended |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Kratz, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
This study's limited qualitative data focused on digital health tool usability is not relevant outside of our efforts to optimize the digital health tool (Me Time MS); therefore release of qualitative data is not planned.
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| ID | Title | Description |
|---|---|---|
| FG000 | Relaxing Self-Acupressure | Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks. Self-guided smartphone application for relaxing acupressure: Relaxing Acupressure entails applying pressure with either a finger, pencil, or similar object to acupressure points. For the relaxing protocol, there is a total of 9 acupoints (1 unilateral and 4 bilateral). Each point will be stimulated for 3 minutes, yielding a total treatment time of 27 minutes each day. The acupoints are:
|
| FG001 | Stimulating Self-Acupressure | Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks. Self-guided smartphone application for relaxing acupressure: There is a total of 10 acupoints (2 unilateral and 4 bilateral). Each point is stimulated for 3 minutes, yielding a total treatment time of 30 minutes each day. The acupoints are:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Relaxing Self-Acupressure | Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks. Self-guided smartphone application for relaxing acupressure: Relaxing Acupressure entails applying pressure with either a finger, pencil, or similar object to acupressure points. For the relaxing protocol, there is a total of 9 acupoints (1 unilateral and 4 bilateral). Each point will be stimulated for 3 minutes, yielding a total treatment time of 27 minutes each day. The acupoints are:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participant Perception of Me Time MS App Usability | Qualitative descriptions of positive, negative, and neutral aspects of usability of the Me Time MS app, gathered through one-on-one, open-ended interviews after 6 weeks of access to the app. Results reflect the total number of comments across all participants that were provided for each category. Participants could submit multiple types of comments. | 3 participants in the Stimulating arm did not attend an interview. | Posted | Number | Comments | Up to 2 weeks after the 6-week app usage period ended | Comments | Comments |
|
Up to 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Relaxing Self-Acupressure | Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks. Self-guided smartphone application for relaxing acupressure: Relaxing Acupressure entails applying pressure with either a finger, pencil, or similar object to acupressure points. For the relaxing protocol, there is a total of 9 acupoints (1 unilateral and 4 bilateral). Each point will be stimulated for 3 minutes, yielding a total treatment time of 27 minutes each day. The acupoints are:
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Kratz | University of Michigan | 734-647-5982 | alkratz@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2025 | Nov 6, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2025 | Sep 5, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D010146 | Pain |
| D005221 | Fatigue |
| D059350 | Chronic Pain |
| 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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|
|
| Self-guided smartphone application for stimulating acupressure | Behavioral | There is a total of 10 acupoints (2 unilateral and 4 bilateral). Each point is stimulated for 3 minutes, yielding a total treatment time of 30 minutes each day. The acupoints are:
|
|
|
| BG001 | Stimulating Self-Acupressure | Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks. Self-guided smartphone application for relaxing acupressure: There is a total of 10 acupoints (2 unilateral and 4 bilateral). Each point is stimulated for 3 minutes, yielding a total treatment time of 30 minutes each day. The acupoints are:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Multiple sclerosis (MS) Subtype | Count of Participants | Participants |
|
| Mobility aid | Count of Participants | Participants |
|
| Patient-determined Disease Steps (PDDS) | Count of Participants | Participants |
|
| OG001 | Stimulating Self-Acupressure | Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks. Self-guided smartphone application for relaxing acupressure: There is a total of 10 acupoints (2 unilateral and 4 bilateral). Each point is stimulated for 3 minutes, yielding a total treatment time of 30 minutes each day. The acupoints are:
|
|
|
| Secondary | System Usability Scale (SUS) Adapted for the MeTime MS App | SUS is a custom, 10-item survey to assess the participant's perception of the usability of the MeTime MS app. Possible total score ranges from 0 (lowest usability) to 40 (highest usability). | 3 participants in the Stimulating Arm did not complete the SUS survey. | Posted | Mean | Standard Deviation | score on a scale | Up to 2 weeks after the 6-week app usage period ended |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 4 |
| 5 |
| EG001 | Stimulating Self-Acupressure | Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks. Self-guided smartphone application for relaxing acupressure: There is a total of 10 acupoints (2 unilateral and 4 bilateral). Each point is stimulated for 3 minutes, yielding a total treatment time of 30 minutes each day. The acupoints are:
| 0 | 5 | 0 | 5 | 1 | 5 |
| Cramping | Nervous system disorders | Systematic Assessment |
|
| Soreness | General disorders | Systematic Assessment |
|
| Difficulty with certain acupoints due to limited mobility | Nervous system disorders | Systematic Assessment |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |