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Just-in-time Adaptive Feedback Systems to Assist Individuals With Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Passive feedback and JITAI
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, Physical Activity, Mobile-health, Just-in-time-adaptive intervention, Real-time feedback

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • between 18-65 years of age
  • have been diagnosed with spinal cord injury
  • are at least 6 months post injury
  • use a manual wheelchair as their primary means of mobility (>80% of the time)
  • self-propel their wheelchair
  • are medically stable
  • have experience using a smartphone.

Exclusion Criteria:

  • have active pelvic or thigh wounds (pressure ulcers)
  • have a history of cardiovascular disease
  • are pregnant (self-report).

Sites / Locations

  • Temple University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Passive feedback and JITAI

Arm Description

Passive feedback and JITAI Second Phase - PA Level Feedback Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI)

Outcomes

Primary Outcome Measures

Change in Physical Activity level
Energy expenditure in kilocalorie as measured by the physical activity monitor system for wheelchair users.
Change in Light-Intensity Physical Activity
Minutes of light-intensity physical activity as measured by the physical activity monitor system for wheelchair users.
Change in Moderate and Vigorous-Intensity Physical Activity
Minutes of moderate and vigorous-intensity physical activity as measured by the physical activity monitor system for wheelchair users.

Secondary Outcome Measures

Change in Light-intensity Leisure Time Physical Activity
Minutes of light-intensity leisure time physical activity per week measured by self-report of Leisure Time Physical Activity Questionnaire for people with SCI.
Change in Moderate and Vigorous-intensity Leisure Time Physical Activity
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.
Change in Pain level for wheelchair users
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.
Change in Pain level
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.
Change in Disability score due to Pain
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.
Change in Fatigue
The fatigue is collected using the Fatigue Severity Scale (FSS). Fatigue scores range from a minimum of 0 to a maximum of 63.

Full Information

First Posted
December 9, 2018
Last Updated
December 10, 2018
Sponsor
Temple University
Collaborators
The Craig H. Neilsen Foundation, Northeastern University, Magee Rehabilitation Hospital, Jefferson Health, MossRehab: Einstein Healthcare Network
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1. Study Identification

Unique Protocol Identification Number
NCT03773692
Brief Title
Just-in-time Adaptive Feedback Systems to Assist Individuals With Spinal Cord Injury
Official Title
Just-in-time Adaptive Feedback Systems to Assist Individuals With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
The Craig H. Neilsen Foundation, Northeastern University, Magee Rehabilitation Hospital, Jefferson Health, MossRehab: Einstein Healthcare Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injuries, Physical Activity, Mobile-health, Just-in-time-adaptive intervention, Real-time feedback

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
Participants were aware of the phase of the study they were in.
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive feedback and JITAI
Arm Type
Experimental
Arm 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(s)
Passive feedback and JITAI
Intervention 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.
Primary Outcome Measure Information:
Title
Change in Physical Activity level
Description
Energy expenditure in kilocalorie as measured by the physical activity monitor system for wheelchair users.
Time Frame
3 months
Title
Change in Light-Intensity Physical Activity
Description
Minutes of light-intensity physical activity as measured by the physical activity monitor system for wheelchair users.
Time Frame
3 months
Title
Change in Moderate and Vigorous-Intensity Physical Activity
Description
Minutes of moderate and vigorous-intensity physical activity as measured by the physical activity monitor system for wheelchair users.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in Light-intensity Leisure Time Physical Activity
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.
Time Frame
3 months
Title
Change in Moderate and Vigorous-intensity Leisure Time Physical Activity
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.
Time Frame
3 months
Title
Change in Pain level for wheelchair users
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.
Time Frame
3 months
Title
Change in Pain level
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.
Time Frame
3 months
Title
Change in Disability score due to Pain
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.
Time Frame
3 months
Title
Change in Fatigue
Description
The fatigue is collected using the Fatigue Severity Scale (FSS). Fatigue scores range from a minimum of 0 to a maximum of 63.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: between 18-65 years of age have been diagnosed with spinal cord injury are at least 6 months post injury use a manual wheelchair as their primary means of mobility (>80% of the time) self-propel their wheelchair are medically stable have experience using a smartphone. Exclusion Criteria: have active pelvic or thigh wounds (pressure ulcers) have a history of cardiovascular disease are pregnant (self-report).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivayogi V Hiremath, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The datasets generated during the current study are not publicly available as the authors do not have the permission to share participants' data.
Citations:
PubMed Identifier
22016146
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.
Results Reference
background
PubMed Identifier
25211208
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.
Results Reference
background
PubMed Identifier
18936771
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.
Results Reference
background
PubMed Identifier
26976800
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.
Results Reference
background
PubMed Identifier
25465284
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.
Results Reference
background
PubMed Identifier
32496966
Citation
Canori A, Amiri AM, Thapa-Chhetry B, Finley MA, Schmidt-Read M, Lamboy MR, Intille SS, Hiremath SV. Relationship between pain, fatigue, and physical activity levels during a technology-based physical activity intervention. J Spinal Cord Med. 2021 Jul;44(4):549-556. doi: 10.1080/10790268.2020.1766889. Epub 2020 Jun 4.
Results Reference
derived

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Just-in-time Adaptive Feedback Systems to Assist Individuals With Spinal Cord Injury

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