- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06578780
Design and Delivery Preferences for Exercise Intervention in People With Spinal Cord Injury
Design and Delivery Preferences for Exercise Intervention in People With Spinal Cord Injury: a Pilot Discrete Choice Experiment
Study Overview
Status
Conditions
Detailed Description
Aim 1. To explore individual preferences and needs that are related to engaging in a physical activity behavior using both qualitative and quantitative approaches.
The identification of attributes will be achieved through (a) qualitative interviews of 30 adults living with SCI, (b) expert opinion of 10 healthcare professionals who have at least 5 years of work experience with SCI patients and in the field of SCI research, and (c) a rapid review of literature reporting on preferred design, equipment, and/or delivery methods for physical activity/exercise programs for people with SCI. For the qualitative approach, we will use semi-structured, one-on-one interviews. Using deductive content analysis, we will generate participant-informed categories that aligned with the "what, when, where, and who" of exercise programs for people with SCI to develop an initial DCE survey.
Participants who take part in this study will engage in two one-on-one interviews that last approximately 1 hour each, depending on how much information is shared with the researcher. The interview will be conducted by the lead researcher via phone or video conference call. The interview will be audio-recorded, which will later be transcribed. The interview will ask questions about your interests, preferences, and wants for a physical activity program that supports initiation and long-term participation. The information shared during the interview will be used to create a preference survey, and the interviewed participants will be contacted again to complete the developed survey and a second interview to see whether the survey fully covered the choices of their needs and wants.
Aim 2. To develop and refine a quantitative DCE survey that contains essential attributes and preference levels for physical activity participation.
The developed initial DCE from Aim 1 will be further refined through the survey responses and feedback from the interviewed participants with SCI as well as iterative discussions with the interviewed healthcare professionals. The evaluation criteria will follow the DCE design guidelines, such as the clarity of the attributes, attribute descriptions, and preference levels; redundancy of attributes and levels defined; and level of burden.
Aim 3. 3-1. To examine which attributes and preference levels are essential and more likely to be accepted for increasing participation in a physical activity intervention.
The developed and refined DCE from Aim 1 and 2 will be pilot tested among 100 people with SCI, who were not involved in the qualitative interview and survey refinement processes. Using conjoint analysis techniques, we will develop prediction models based on the possible combinations of attributes and levels (e.g., 24 combinations = 3 levels of "what" x 2 of "when" x 2 of "where" x 2 of "who").
3-2. To examine whether these preferences vary by participants' personal and clinical characteristics, such as age, functional level, residential area (urban vs. rural), and self-reported physical activity and motivational readiness to physical activity behavior change (pre-intenders, intenders, actors).
Hypothesis:
Adults with SCI who are currently meeting/exceeding physical activity guidelines (actors) will choose a self-guided physical activity program over a supervised, instructor-led program. Adults with SCI who have a high level of self-regulatory skills (goal setting and planning) will choose a self-guided physical activity program over a supervised, instructor-led program.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35209
- Wellness, Health and Research Facility (WHARF)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- adults (≥18 years) with spinal cord injury
- able to converse and read in English
Exclusion Criteria:
- presence of cognitive impairment that prevents adhering to the study protocol
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographics & clinical information
Time Frame: Baseline, during the first interview
|
age, ethnicity, race, date of spinal cord injury onset, injury level, injury type
|
Baseline, during the first interview
|
|
Physical activity
Time Frame: Baseline, during the first interview
|
Complete LTPAQ-SCI online survey (mins of physical activity per week)
|
Baseline, during the first interview
|
|
Physical activity
Time Frame: 3-month follow-up, before the second interview
|
Complete LTPAQ-SCI online survey (mins of physical activity per week)
|
3-month follow-up, before the second interview
|
|
Preference survey
Time Frame: 3-month follow-up, before the second interview
|
Developed preference survey based on the first interview
|
3-month follow-up, before the second interview
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yumi Kim, PhD, University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300012355
- 1143477 (Other Grant/Funding Number: Craig H. Neilsen Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injuries
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingInjury, Spinal Cord
-
Khon Kaen UniversityUnknownInjuries, Spinal Cord
-
Institut GuttmannNot yet recruitingSpinal Cord Injury | Spinal Cord Disease | Spinal Cord Injuries (SCI) | Traumatic Spinal Cord InjuriesSpain
-
Universidade do Vale do ParaíbaCompletedInjuries, Spinal Cord
-
InVivo TherapeuticsTerminated
-
Chang Gung Memorial HospitalNot yet recruitingSpine Injury | Complete Spinal Cord Injury | Incomplete Spinal Cord Injury | Cord Injury, Spinal | Cord Infarction Spinal
-
Kessler FoundationNot yet recruitingSpinal Cord Injury | Spinal Cord Disease | Spinal Cord Injuries (SCI)United States
-
Ekso BionicsBurke Medical Research InstituteCompletedInjuries, Spinal CordUnited States
-
ReWalk Robotics, Inc.Unknown