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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01AG062754-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This pilot study will test the feasibility of pairing a social network-based approach with a 6-week Occupational Therapist (OT)-led intervention administered remotely (via Zoom) to increase physical function and activity among residents of a HUD subsidized independent-living senior housing community. The intervention is called Tele-Video to Improve Daily Activity (T-VIDA) and will be administered with two cohorts of residents in a single community. The study has two main goals: 1) To determine if an OT-led program administered remotely over the internet using Zoom is useful in helping residents increase their physical activity; and 2) to determine if involving respected members of the community in the program as Advisory Committee members has an impact on how much other residents participate in program activities and engage in behaviors discussed. The OT intervention will be comprised of a combination of adapted components from multiple evidence-based interventions including individual meetings with an OT and OT-led group sessions. To evaluate the intervention pre- and post-program interviews will be conducted with participants over the phone, and activity monitoring will be conducted after both the pre- and post-program interviews for 7-days using an activity monitoring device. The following hypotheses will be tested: 1) at least 75% (3 of 4) of identified residents will accept the invitation to serve on the Advisory Committee; 2) Advisory Committee Members will attend at least 2 of 3 committee meetings; 3) Participants will on average participate in at least 70% (7 of 10) of intervention activities; 4) Residents knowing one or more committee members at baseline will participate in more intervention activities compared to those who do not; and 5) The influence of knowing a committee member on participation will be greater among residents reporting more pain at baseline compared to those reporting less pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| occupational therapy intervention group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-Video to Improve Daily Activity | Behavioral | Participants will be asked to meet individually with an Occupational Therapist (OT) via Zoom to assess activity performance, establish short-term activity goals, and outline an individualized home exercise program. Participants will also be asked to participate in 4 weekly one hour group sessions via Zoom that will include: 1) education; 2) OT facilitated discussion; and 3) activity demonstration, engagement and feedback. The following topics will be covered: mobility, physical activity, pain management, and energy conservation. Participants will be asked to meet individually with the OT via Zoom for 15-20 minutes weekly to answer questions. At the end, participants will be asked to again meet individually with the OT via Zoom to re-assess activity performance and revisit short-term activity goals and the individualized home exercise program. Advisory Committee Members will be asked to make note of intervention activities during their regular interactions with other participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Process Outcome - Advisory Committee Members Accept Invitation | Number of originally identified potential Advisory Commitee Members who accept the invitation to serve on the committee. Possible scores range from 0 to 1. | 1 week pre-intervention |
| Process Outcome - Advisory Committee Member Participation | Number of committee meetings attended by Advisory Committee Members. Possible scores range from 0 to 3. | Week 5 of intervention |
| Process Outcome - Individual Activity Participation | Number of individual (one-on-one) intervention activities attended by participants. Possible scores range from 0 to 6. | Immediately after the intervention, 6 weeks after the intervention started |
| Process Outcome - Group Activity Participation | Number of group intervention activities attended by participants. Possible scores range from 0 to 4. | Immediately after the intervention, 6 weeks after the intervention started |
| Process Outcome - Total Activity Participation | Total number of intervention activities attended by participants (individual and group). Possible scores range from 0 to 10. | Immediately after the intervention, 6 weeks after the intervention started |
| Process Outcome - Number Acitivites Via Zoom | Number of activities attended via zoom as opposed to calling in by telephone. Possible scores range from 0 to 10. | Immediately after the intervention, 6 weeks after the intervention started |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-reported Physical Activity | Modified Community Health Activities Model Program questionnaire. This includes 16 questions/items that measure the number of times and the frequency of each activity engaged in during a typical week in the past month. The response scale for each of the 16 items ranges from 1=less than 1 hour to 6=9 or more hours. On this scale, higher values represent a better outcome. A total self-reported physical activity score is calculated by averaging the score of all 16 items. The range for the total score also ranges from 1 to 6. Change will be measured by creating a difference score between the pre and post intervention total scores. Positive change scores represent a better outcome, i.e., an increase in self-reported physical activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noah J Webster, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48104 | United States |
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Starting 6 months after publication
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: occupational therapy intervention group | Behavioral: Tele-Video to Improve Daily Activity Participants will be asked to meet individually with an Occupational Therapist (OT) via Zoom to assess activity performance, establish short-term activity goals, and outline an individualized home exercise program. Participants will also be asked to participate in 4 weekly one hour group sessions via Zoom that will include: 1) education; 2) OT facilitated discussion; and 3) activity demonstration, engagement and feedback. The following topics will be covered: mobility, physical activity, pain management, and energy conservation. Participants will be asked to meet individually with the OT via Zoom for 15-20 minutes weekly to answer questions. At the end, participants will be asked to again meet individually with the OT via Zoom to re-assess activity performance and revisit short-term activity goals and the individualized home exercise program. Advisory Committee Members will be asked to make note of intervention activities during their regular interactions with other participants. Advisory Committee Members will be selected from the group of enrolled participants, and will not be considered additional participants in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Occupational Therapy Intervention Group | Behavioral: Tele-Video to Improve Daily Activity Participants will be asked to meet individually with an Occupational Therapist (OT) via Zoom to assess activity performance, establish short-term activity goals, and outline an individualized home exercise program. Participants will also be asked to participate in 4 weekly one hour group sessions via Zoom that will include: 1) education; 2) OT facilitated discussion; and 3) activity demonstration, engagement and feedback. The following topics will be covered: mobility, physical activity, pain management, and energy conservation. Participants will be asked to meet individually with the OT via Zoom for 15-20 minutes weekly to answer questions. At the end, participants will be asked to again meet individually with the OT via Zoom to re-assess activity performance and revisit short-term activity goals and the individualized home exercise program. Advisory Committee Members will be asked to make note of intervention activities during their regular interactions with other participants. Advisory Committee Members will be selected from the group of enrolled participants, and will not be considered additional participants in the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Process Outcome - Advisory Committee Members Accept Invitation | Number of originally identified potential Advisory Commitee Members who accept the invitation to serve on the committee. Possible scores range from 0 to 1. | Posted | Number | Participants | 1 week pre-intervention |
|
10 weeks
Systematic collection done by regular investigator assessment; weekly check-in intervention meetings with an occupational therapist, where adverse events were asked about and recorded
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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 | Experimental: occupational therapy intervention group | Behavioral: Tele-Video to Improve Daily Activity Participants will be asked to meet individually with an Occupational Therapist (OT) via Zoom to assess activity performance, establish short-term activity goals, and outline an individualized home exercise program. Participants will also be asked to participate in 4 weekly one hour group sessions via Zoom that will include: 1) education; 2) OT facilitated discussion; and 3) activity demonstration, engagement and feedback. The following topics will be covered: mobility, physical activity, pain management, and energy conservation. Participants will be asked to meet individually with the OT via Zoom for 15-20 minutes weekly to answer questions. At the end, participants will be asked to again meet individually with the OT via Zoom to re-assess activity performance and revisit short-term activity goals and the individualized home exercise program. Advisory Committee Members will be asked to make note of intervention activities during their regular interactions with other participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Noah J. Webster | University of Michigan | 734-936-3075 | njwebs@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 | Sep 19, 2024 | Oct 17, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2023 | Jan 7, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| 1 week pre and 1 week post the 6-week intervention |
| Change in Perceived Barriers to Physical Activity | This includes 17 questions/items that measure the degree to which specific things make it more difficult for participants to engage in 30 minutes of moderate intensity physical activity on 5 or more days a week. The response scale for each of the 17 items ranges from 1=not at all more difficult to 4=much more difficult. On this scale, lower values represent a better outcome. A total perceived barriers to physical activity score is calculated by averaging the score of all 17 items. The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in perceived barriers to physical activity. | 1 week pre and 1 week post the 6-week intervention |
| Change in Pain Interference | This includes 8 questions/items that measure how much pain interferes with daily activities. The response scale for each the 8 items ranges from 1=not at all to 5=very much. On this scale, lower values represent a better outcome. A total pain interference score is calculated by averaging the score of all 8 items. The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in pain interference. | 1 week pre and 1 week post the 6-week intervention |
| Change in Pain Intensity | This includes one question about how participants rate their pain on average using a scale ranging from 0=no pain to 10=the worst imaginable pain. Change will be measured by creating a difference score between the pre and post intervention scores. | 1 week pre and 1 week post the 6-week intervention |
| Change in Physical Function Difficulty | This includes a modified version of the National Health and Aging Trends Study disability and functioning measure. The measure includes 11 questions/items assessing difficulty performing self-care, mobility, and household activities. The response scale for each of the 11 items asking about difficulty doing these activities ranges from 1=none to 4=a lot. On this scale, lower values represent a better outcome. A total physical function difficulty score is calculated by averaging the score of all 11 items. The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in physical function difficulty. | 1 week pre and 1 week post the 6-week intervention |
| Change in Self-efficacy in Activity | This includes 10 questions/items that measure participants' confidence in doing a number of activities that will be discussed during the intervention. The response scale for each of the 10 items ranges from 1=not confident at all to 5=completely confident. On this scale, higher values represent a better outcome. A total self-efficacy in activity score is calculated by averaging the score of all 10 items. The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores. Positive change scores represent a better outcome, i.e., an increase in self-efficacy in activity. | 1 week pre and 1 week post the 6-week intervention |
| Change in Percentage of Other Participants Known | This will include a measure of the percentage of other participants each participant reports knowing. Possible scores range from 0 to 100. Change will be measured by creating a difference score between the pre and post intervention scores. | 1 week pre and 1 week post the 6-week intervention |
| Change in Respect Level of Other Participants | This will include a measure of how much respect on average participants have for the other participants that they report knowing. This question will be asked on a scale ranging from 1=respect them very much to 5=don't respect them at all. Change will be measured by creating a difference score between the pre and post intervention scores. | 1 week pre and 1 week post the 6-week intervention |
| Change in Sedentary Behavior | Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average amount of time that participants were sedentary per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores. | 1 week pre and 1 week post the 6-week intervention |
| Change in Number of Steps | Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average number of steps taken per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores. | 1 week pre and 1 week post the 6-week intervention |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Primary | Process Outcome - Advisory Committee Member Participation | Number of committee meetings attended by Advisory Committee Members. Possible scores range from 0 to 3. | Posted | Number | Number of meetings attended | Week 5 of intervention |
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| Primary | Process Outcome - Individual Activity Participation | Number of individual (one-on-one) intervention activities attended by participants. Possible scores range from 0 to 6. | Posted | Mean | Standard Deviation | Number of one-on-one activities attended | Immediately after the intervention, 6 weeks after the intervention started |
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| Primary | Process Outcome - Group Activity Participation | Number of group intervention activities attended by participants. Possible scores range from 0 to 4. | Posted | Mean | Standard Deviation | Number of group activities attended | Immediately after the intervention, 6 weeks after the intervention started |
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| Primary | Process Outcome - Total Activity Participation | Total number of intervention activities attended by participants (individual and group). Possible scores range from 0 to 10. | Posted | Mean | Standard Deviation | # of intervention activities attended | Immediately after the intervention, 6 weeks after the intervention started |
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| Primary | Process Outcome - Number Acitivites Via Zoom | Number of activities attended via zoom as opposed to calling in by telephone. Possible scores range from 0 to 10. | Posted | Mean | Standard Deviation | Number of activities attended on Zoom | Immediately after the intervention, 6 weeks after the intervention started |
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| Secondary | Change in Self-reported Physical Activity | Modified Community Health Activities Model Program questionnaire. This includes 16 questions/items that measure the number of times and the frequency of each activity engaged in during a typical week in the past month. The response scale for each of the 16 items ranges from 1=less than 1 hour to 6=9 or more hours. On this scale, higher values represent a better outcome. A total self-reported physical activity score is calculated by averaging the score of all 16 items. The range for the total score also ranges from 1 to 6. Change will be measured by creating a difference score between the pre and post intervention total scores. Positive change scores represent a better outcome, i.e., an increase in self-reported physical activity. | Posted | Mean | Standard Deviation | Units on scale | 1 week pre and 1 week post the 6-week intervention |
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| Secondary | Change in Perceived Barriers to Physical Activity | This includes 17 questions/items that measure the degree to which specific things make it more difficult for participants to engage in 30 minutes of moderate intensity physical activity on 5 or more days a week. The response scale for each of the 17 items ranges from 1=not at all more difficult to 4=much more difficult. On this scale, lower values represent a better outcome. A total perceived barriers to physical activity score is calculated by averaging the score of all 17 items. The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in perceived barriers to physical activity. | Posted | Mean | Standard Deviation | Units on a scale | 1 week pre and 1 week post the 6-week intervention |
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| Secondary | Change in Pain Interference | This includes 8 questions/items that measure how much pain interferes with daily activities. The response scale for each the 8 items ranges from 1=not at all to 5=very much. On this scale, lower values represent a better outcome. A total pain interference score is calculated by averaging the score of all 8 items. The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in pain interference. | Posted | Mean | Standard Deviation | Units on a scale | 1 week pre and 1 week post the 6-week intervention |
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| Secondary | Change in Pain Intensity | This includes one question about how participants rate their pain on average using a scale ranging from 0=no pain to 10=the worst imaginable pain. Change will be measured by creating a difference score between the pre and post intervention scores. | Posted | Mean | Standard Deviation | Units on a scale | 1 week pre and 1 week post the 6-week intervention |
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| Secondary | Change in Physical Function Difficulty | This includes a modified version of the National Health and Aging Trends Study disability and functioning measure. The measure includes 11 questions/items assessing difficulty performing self-care, mobility, and household activities. The response scale for each of the 11 items asking about difficulty doing these activities ranges from 1=none to 4=a lot. On this scale, lower values represent a better outcome. A total physical function difficulty score is calculated by averaging the score of all 11 items. The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in physical function difficulty. | Posted | Mean | Standard Deviation | Units on a scale | 1 week pre and 1 week post the 6-week intervention |
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| Secondary | Change in Self-efficacy in Activity | This includes 10 questions/items that measure participants' confidence in doing a number of activities that will be discussed during the intervention. The response scale for each of the 10 items ranges from 1=not confident at all to 5=completely confident. On this scale, higher values represent a better outcome. A total self-efficacy in activity score is calculated by averaging the score of all 10 items. The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores. Positive change scores represent a better outcome, i.e., an increase in self-efficacy in activity. | Posted | Mean | Standard Deviation | Units on a scale | 1 week pre and 1 week post the 6-week intervention |
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| Secondary | Change in Percentage of Other Participants Known | This will include a measure of the percentage of other participants each participant reports knowing. Possible scores range from 0 to 100. Change will be measured by creating a difference score between the pre and post intervention scores. | Posted | Mean | Standard Deviation | Percentage of other participants known | 1 week pre and 1 week post the 6-week intervention |
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| Secondary | Change in Respect Level of Other Participants | This will include a measure of how much respect on average participants have for the other participants that they report knowing. This question will be asked on a scale ranging from 1=respect them very much to 5=don't respect them at all. Change will be measured by creating a difference score between the pre and post intervention scores. | Posted | Mean | Standard Deviation | Units on a scale | 1 week pre and 1 week post the 6-week intervention |
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| Secondary | Change in Sedentary Behavior | Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average amount of time that participants were sedentary per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores. | Posted | Mean | Standard Deviation | Minutes per day | 1 week pre and 1 week post the 6-week intervention |
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| Secondary | Change in Number of Steps | Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average number of steps taken per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores. | Posted | Mean | Standard Deviation | Accelerometer step count per day | 1 week pre and 1 week post the 6-week intervention |
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| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
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| Dizziness | Vascular disorders | Systematic Assessment | Related |
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| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated |
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| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Related, from Tegaderm |
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| Emotional distress | Psychiatric disorders | Systematic Assessment | Unrelated |
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| Car accident | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated |
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