<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03773692</url>
  </required_header>
  <id_info>
    <org_study_id>23822</org_study_id>
    <nct_id>NCT03773692</nct_id>
  </id_info>
  <brief_title>Just-in-time Adaptive Feedback Systems to Assist Individuals With Spinal Cord Injury</brief_title>
  <official_title>Just-in-time Adaptive Feedback Systems to Assist Individuals With Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Craig H. Neilsen Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northeastern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Magee Rehabilitation Hospital, Jefferson Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MossRehab: Einstein Healthcare Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to develop algorithms that incorporate each individual's&#xD;
      automatically detected physical activity (PA) level and a clinician's PA level recommendation&#xD;
      to provide a smartphone application that helps a person set safe and highly personalized PA&#xD;
      goals. By adapting the goals in real-time based on the person's actual behavior, the system&#xD;
      aims to keep the individual feeling positive and motivated towards a change in the PA&#xD;
      behavior.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lack of regular physical activity (PA) in the general population is a top public health&#xD;
      concern, and this problem is even more acute among individuals with spinal cord injury (SCI).&#xD;
      Research has shown that only a small percentage (&lt;20%) of persons with SCI reported&#xD;
      consistent PA. Individuals with SCI also experience secondary conditions such as pain,&#xD;
      fatigue, weight gain, and deconditioning, conditions that are considered preventable through&#xD;
      PA and exercise interventions.&#xD;
&#xD;
      The objective of this proposed study is to develop algorithms that incorporate each&#xD;
      individual's PA level and a clinician's PA level recommendation to provide a mobile phone&#xD;
      application that helps a person set PA goals that are safe, but also highly personalized. By&#xD;
      adapting the goals in real-time based on the person's actual behavior, the system aims to&#xD;
      keep the individual feeling positive and motivated.&#xD;
&#xD;
      Aim 1: Extend and utilize Physical Activity Monitor System (PAMS) to track PA levels,&#xD;
      sedentary behavior, and secondary conditions such as pain, fatigue, and deconditioning in&#xD;
      community settings.&#xD;
&#xD;
      Aim 2: Extend and utilize PAMS to passively monitor PA and provide continuous, but passive&#xD;
      feedback about PA levels to individuals with SCI in community settings.&#xD;
&#xD;
      Aim 3: Extend and utilize PAMS to passively monitor PA and provide just-in-time persuasive&#xD;
      and adaptive feedback to motivate individuals with SCI in community settings.&#xD;
&#xD;
      Sample size: A total of 20 individuals with SCI will take part in the study. The sample size&#xD;
      for this pilot study is based on budget constraints and other pilot studies. This study will&#xD;
      provide the pilot data required to compute the power for future studies.&#xD;
&#xD;
      Statistical Analysis: Univariate analysis will be performed to obtain a range of values and&#xD;
      the central tendency for variables such as PA levels and sedentary behaviors. Sedentary&#xD;
      behavior will be assessed by the time duration of non-movement of individuals with SCI and&#xD;
      not just the total duration of being seated in their wheelchairs.&#xD;
&#xD;
      The investigators hypothesize that the PA level of individuals with SCI in community will be&#xD;
      low compared to the PA level recommendations for individuals with disabilities in general.&#xD;
      Furthermore, the sedentary behavior of individuals with SCI will be high compared to the&#xD;
      general population.&#xD;
&#xD;
      Multiple regression analysis will be performed to assess a relationship between secondary&#xD;
      conditions such as pain (scores), fatigue (scores), and deconditioning (reduced capacity&#xD;
      scores) and PA levels. The investigators postulate that secondary conditions will be&#xD;
      negatively correlated with the PA levels.&#xD;
&#xD;
      Repeated measures general linear model (GLM) analysis will be performed to assess the change&#xD;
      in PA levels, sedentary behaviors and secondary conditions. In addition, linear mixed model&#xD;
      analysis will be performed to develop a personal intercept (and maybe slope) for each&#xD;
      participant compared to the mean intercept for each group. Mixed effects model analysis will&#xD;
      provide correct estimates of intervention (passive feedback and just-in-time adaptive&#xD;
      feedback) and other fixed effects (within-subjects factor) in the presence of correlated data&#xD;
      (each participant at different time points) that arise from a data hierarchy (group).&#xD;
      Non-parametric tests will be performed if the assumptions for parametric tests are not met.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">November 21, 2018</completion_date>
  <primary_completion_date type="Actual">November 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Each individual will take part in the study for three phases, each with a duration of one month. The first month will involve collecting baseline PA levels. The second and third months of the study will provide the participants with passive PA level feedback and just-in-time persuasive feedback about their PA levels, respectively.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Participants were aware of the phase of the study they were in.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Physical Activity level</measure>
    <time_frame>3 months</time_frame>
    <description>Energy expenditure in kilocalorie as measured by the physical activity monitor system for wheelchair users.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Light-Intensity Physical Activity</measure>
    <time_frame>3 months</time_frame>
    <description>Minutes of light-intensity physical activity as measured by the physical activity monitor system for wheelchair users.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Moderate and Vigorous-Intensity Physical Activity</measure>
    <time_frame>3 months</time_frame>
    <description>Minutes of moderate and vigorous-intensity physical activity as measured by the physical activity monitor system for wheelchair users.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Light-intensity Leisure Time Physical Activity</measure>
    <time_frame>3 months</time_frame>
    <description>Minutes of light-intensity leisure time physical activity per week measured by self-report of Leisure Time Physical Activity Questionnaire for people with SCI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Moderate and Vigorous-intensity Leisure Time Physical Activity</measure>
    <time_frame>3 months</time_frame>
    <description>Minutes of moderate and vigorous-intensity leisure time physical activity per week measured by self-report of Leisure Time Physical Activity Questionnaire for people with SCI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain level for wheelchair users</measure>
    <time_frame>3 months</time_frame>
    <description>The pain level for wheelchair users is collected using the Wheelchair Users Shoulder Pain Index. The score ranges from a minimum pain level of 0 to a maximum pain level of 150.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain level</measure>
    <time_frame>3 months</time_frame>
    <description>The general pain level was collected using the Chronic Pain Grade scale. The pain intensity score ranges from a minimum pain level of 0 to a maximum pain level of 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Disability score due to Pain</measure>
    <time_frame>3 months</time_frame>
    <description>The general pain level was collected using the Chronic Pain Grade scale. Disability scores range from a minimum of 0 to a maximum of 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fatigue</measure>
    <time_frame>3 months</time_frame>
    <description>The fatigue is collected using the Fatigue Severity Scale (FSS). Fatigue scores range from a minimum of 0 to a maximum of 63.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Passive feedback and JITAI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Passive feedback and JITAI&#xD;
Second Phase - PA Level Feedback Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Passive feedback and JITAI</intervention_name>
    <description>Second Phase - PA Level Feedback&#xD;
A PA recommendation handout based on PA guidelines for individuals with SCI will be provided. Participants continue to use the same sensing equipment as in phase one (baseline). The equipment consists of a smartwatch, a smartphone, and a wheel rotation monitor. Participants can view their feedback whenever they want, but will not be prompted with the information.&#xD;
Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI)&#xD;
The third phase of the study will be similar to the second phase of the study, but with an additional JITAI component. The JITAI component of the study will include providing proactively-prompted, real-time feedback through the smartphone and smartwatch when the participant performs a bout of moderate PA.</description>
    <arm_group_label>Passive feedback and JITAI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between 18-65 years of age&#xD;
&#xD;
          -  have been diagnosed with spinal cord injury&#xD;
&#xD;
          -  are at least 6 months post injury&#xD;
&#xD;
          -  use a manual wheelchair as their primary means of mobility (&gt;80% of the time)&#xD;
&#xD;
          -  self-propel their wheelchair&#xD;
&#xD;
          -  are medically stable&#xD;
&#xD;
          -  have experience using a smartphone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have active pelvic or thigh wounds (pressure ulcers)&#xD;
&#xD;
          -  have a history of cardiovascular disease&#xD;
&#xD;
          -  are pregnant (self-report).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shivayogi V Hiremath, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rimmer JH, Schiller W, Chen MD. Effects of disability-associated low energy expenditure deconditioning syndrome. Exerc Sport Sci Rev. 2012 Jan;40(1):22-9. doi: 10.1097/JES.0b013e31823b8b82.</citation>
    <PMID>22016146</PMID>
  </reference>
  <reference>
    <citation>Williams TL, Smith B, Papathomas A. The barriers, benefits and facilitators of leisure time physical activity among people with spinal cord injury: a meta-synthesis of qualitative findings. Health Psychol Rev. 2014;8(4):404-25. doi: 10.1080/17437199.2014.898406. Epub 2014 Mar 26.</citation>
    <PMID>25211208</PMID>
  </reference>
  <reference>
    <citation>Tawashy AE, Eng JJ, Lin KH, Tang PF, Hung C. Physical activity is related to lower levels of pain, fatigue and depression in individuals with spinal-cord injury: a correlational study. Spinal Cord. 2009 Apr;47(4):301-6. doi: 10.1038/sc.2008.120. Epub 2008 Oct 21.</citation>
    <PMID>18936771</PMID>
  </reference>
  <reference>
    <citation>Hiremath SV, Intille SS, Kelleher A, Cooper RA, Ding D. Estimation of Energy Expenditure for Wheelchair Users Using a Physical Activity Monitoring System. Arch Phys Med Rehabil. 2016 Jul;97(7):1146-1153.e1. doi: 10.1016/j.apmr.2016.02.016. Epub 2016 Mar 11.</citation>
    <PMID>26976800</PMID>
  </reference>
  <reference>
    <citation>Hiremath SV, Intille SS, Kelleher A, Cooper RA, Ding D. Detection of physical activities using a physical activity monitor system for wheelchair users. Med Eng Phys. 2015 Jan;37(1):68-76. doi: 10.1016/j.medengphy.2014.10.009. Epub 2014 Nov 10.</citation>
    <PMID>25465284</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal Cord Injuries</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Mobile-health</keyword>
  <keyword>Just-in-time-adaptive intervention</keyword>
  <keyword>Real-time feedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The datasets generated during the current study are not publicly available as the authors do not have the permission to share participants' data.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03773692
org study id: 23822
nct id: NCT03773692
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to develop algorithms that incorporate each individual's
      automatically detected physical activity (PA) level and a clinician's PA level recommendation
      to provide a smartphone application that helps a person set safe and highly personalized PA
      goals. By adapting the goals in real-time based on the person's actual behavior, the system
      aims to keep the individual feeling positive and motivated towards a change in the PA
      behavior.
Lack of regular physical activity (PA) in the general population is a top public health
      concern, and this problem is even more acute among individuals with spinal cord injury (SCI).
      Research has shown that only a small percentage (<20%) of persons with SCI reported
      consistent PA. Individuals with SCI also experience secondary conditions such as pain,
      fatigue, weight gain, and deconditioning, conditions that are considered preventable through
      PA and exercise interventions.

      The objective of this proposed study is to develop algorithms that incorporate each
      individual's PA level and a clinician's PA level recommendation to provide a mobile phone
      application that helps a person set PA goals that are safe, but also highly personalized. By
      adapting the goals in real-time based on the person's actual behavior, the system aims to
      keep the individual feeling positive and motivated.

      Aim 1: Extend and utilize Physical Activity Monitor System (PAMS) to track PA levels,
      sedentary behavior, and secondary conditions such as pain, fatigue, and deconditioning in
      community settings.

      Aim 2: Extend and utilize PAMS to passively monitor PA and provide continuous, but passive
      feedback about PA levels to individuals with SCI in community settings.

      Aim 3: Extend and utilize PAMS to passively monitor PA and provide just-in-time persuasive
      and adaptive feedback to motivate individuals with SCI in community settings.

      Sample size: A total of 20 individuals with SCI will take part in the study. The sample size
      for this pilot study is based on budget constraints and other pilot studies. This study will
      provide the pilot data required to compute the power for future studies.

      Statistical Analysis: Univariate analysis will be performed to obtain a range of values and
      the central tendency for variables such as PA levels and sedentary behaviors. Sedentary
      behavior will be assessed by the time duration of non-movement of individuals with SCI and
      not just the total duration of being seated in their wheelchairs.

      The investigators hypothesize that the PA level of individuals with SCI in community will be
      low compared to the PA level recommendations for individuals with disabilities in general.
      Furthermore, the sedentary behavior of individuals with SCI will be high compared to the
      general population.

      Multiple regression analysis will be performed to assess a relationship between secondary
      conditions such as pain (scores), fatigue (scores), and deconditioning (reduced capacity
      scores) and PA levels. The investigators postulate that secondary conditions will be
      negatively correlated with the PA levels.

      Repeated measures general linear model (GLM) analysis will be performed to assess the change
      in PA levels, sedentary behaviors and secondary conditions. In addition, linear mixed model
      analysis will be performed to develop a personal intercept (and maybe slope) for each
      participant compared to the mean intercept for each group. Mixed effects model analysis will
      provide correct estimates of intervention (passive feedback and just-in-time adaptive
      feedback) and other fixed effects (within-subjects factor) in the presence of correlated data
      (each participant at different time points) that arise from a data hierarchy (group).
      Non-parametric tests will be performed if the assumptions for parametric tests are not met.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Each individual will take part in the study for three phases, each with a duration of one month. The first month will involve collecting baseline PA levels. The second and third months of the study will provide the participants with passive PA level feedback and just-in-time persuasive feedback about their PA levels, respectively.
primary purpose: Prevention
masking: None (Open Label)
masking description: Participants were aware of the phase of the study they were in.
measure: Change in Physical Activity level
time frame: 3 months
description: Energy expenditure in kilocalorie as measured by the physical activity monitor system for wheelchair users.
measure: Change in Light-Intensity Physical Activity
time frame: 3 months
description: Minutes of light-intensity physical activity as measured by the physical activity monitor system for wheelchair users.
measure: Change in Moderate and Vigorous-Intensity Physical Activity
time frame: 3 months
description: Minutes of moderate and vigorous-intensity physical activity as measured by the physical activity monitor system for wheelchair users.
measure: Change in Light-intensity Leisure Time Physical Activity
time frame: 3 months
description: Minutes of light-intensity leisure time physical activity per week measured by self-report of Leisure Time Physical Activity Questionnaire for people with SCI.
measure: Change in Moderate and Vigorous-intensity Leisure Time Physical Activity
time frame: 3 months
description: Minutes of moderate and vigorous-intensity leisure time physical activity per week measured by self-report of Leisure Time Physical Activity Questionnaire for people with SCI.
measure: Change in Pain level for wheelchair users
time frame: 3 months
description: The pain level for wheelchair users is collected using the Wheelchair Users Shoulder Pain Index. The score ranges from a minimum pain level of 0 to a maximum pain level of 150.
measure: Change in Pain level
time frame: 3 months
description: The general pain level was collected using the Chronic Pain Grade scale. The pain intensity score ranges from a minimum pain level of 0 to a maximum pain level of 100.
measure: Change in Disability score due to Pain
time frame: 3 months
description: The general pain level was collected using the Chronic Pain Grade scale. Disability scores range from a minimum of 0 to a maximum of 100.
measure: Change in Fatigue
time frame: 3 months
description: The fatigue is collected using the Fatigue Severity Scale (FSS). Fatigue scores range from a minimum of 0 to a maximum of 63.
arm group label: Passive feedback and JITAI
arm group type: Experimental
description: Passive feedback and JITAI
Second Phase - PA Level Feedback Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI)
intervention type: Behavioral
intervention name: Passive feedback and JITAI
description: Second Phase - PA Level Feedback
A PA recommendation handout based on PA guidelines for individuals with SCI will be provided. Participants continue to use the same sensing equipment as in phase one (baseline). The equipment consists of a smartwatch, a smartphone, and a wheel rotation monitor. Participants can view their feedback whenever they want, but will not be prompted with the information.
Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI)
The third phase of the study will be similar to the second phase of the study, but with an additional JITAI component. The JITAI component of the study will include providing proactively-prompted, real-time feedback through the smartphone and smartwatch when the participant performs a bout of moderate PA.
arm group label: Passive feedback and JITAI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shivayogi V Hiremath, PhD
role: Principal Investigator
affiliation: Temple University
facility: 
country: United States
citation: Rimmer JH, Schiller W, Chen MD. Effects of disability-associated low energy expenditure deconditioning syndrome. Exerc Sport Sci Rev. 2012 Jan;40(1):22-9. doi: 10.1097/JES.0b013e31823b8b82.
PMID: 22016146
citation: Williams TL, Smith B, Papathomas A. The barriers, benefits and facilitators of leisure time physical activity among people with spinal cord injury: a meta-synthesis of qualitative findings. Health Psychol Rev. 2014;8(4):404-25. doi: 10.1080/17437199.2014.898406. Epub 2014 Mar 26.
PMID: 25211208
citation: Tawashy AE, Eng JJ, Lin KH, Tang PF, Hung C. Physical activity is related to lower levels of pain, fatigue and depression in individuals with spinal-cord injury: a correlational study. Spinal Cord. 2009 Apr;47(4):301-6. doi: 10.1038/sc.2008.120. Epub 2008 Oct 21.
PMID: 18936771
citation: Hiremath SV, Intille SS, Kelleher A, Cooper RA, Ding D. Estimation of Energy Expenditure for Wheelchair Users Using a Physical Activity Monitoring System. Arch Phys Med Rehabil. 2016 Jul;97(7):1146-1153.e1. doi: 10.1016/j.apmr.2016.02.016. Epub 2016 Mar 11.
PMID: 26976800
citation: Hiremath SV, Intille SS, Kelleher A, Cooper RA, Ding D. Detection of physical activities using a physical activity monitor system for wheelchair users. Med Eng Phys. 2015 Jan;37(1):68-76. doi: 10.1016/j.medengphy.2014.10.009. Epub 2014 Nov 10.
PMID: 25465284
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: No
ipd description: The datasets generated during the current study are not publicly available as the authors do not have the permission to share participants' data.