Clinical trial NCT06578780: Design and Delivery Preferences for Exercise Intervention in People with Spinal Cord Injury
Official title: Design and Delivery Preferences for Exercise Intervention in People with Spinal Cord Injury: a Pilot Discrete Choice Experiment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Cord Injuries
Keywords: Spinal cord injury
Exercise
Adults
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2024-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Any adults with spinal cord injury interested in participating in this study.

Brief summary: This research study aims to explore people's understanding of physical activity behavior and perceptions of what a physical activity program should include for supporting initiation and continuous participation. This study will enroll up to 30 adults (18 or over) with spinal cord injury. The study will use a discrete choice experiment (DCE) design that implements both quantitative (development of preference survey) and qualitative approaches (systematic review; test of preference survey).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographics & clinical information
timeFrame: Baseline, during the first interview
measure: Physical activity
timeFrame: Baseline, during the first interview
measure: Physical activity
timeFrame: 3-month follow-up, before the second interview
measure: Preference survey
timeFrame: 3-month follow-up, before the second interview
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Wellness, Health and Research Facility (WHARF)
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Yumi Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: