Clinical trial NCT06227000: Living Longer and Stronger With Spinal Cord Injury (SCI)
Official title: Living Longer and Stronger With Spinal Cord Injury: An Online Program for Promoting Healthy Aging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
aging
health promotion
intervention
randomized controlled trial
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2024-01-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to develop a health promotion group intervention to meet the unique health promotion needs of people aging with SCI, to test the efficacy of the adapted intervention program, Living Longer and Stronger with SCI, in a randomized controlled trial and to assess the mechanisms through which the intervention may enhance physical, psychological, and social health.


Eligibility criteria: Inclusion Criteria:

* traumatic spinal cord injury (SCI)
* have traumatic SCI for at least 15 years OR be over the age of 45
* use a manual or power wheelchair for mobility at least some of the time
* reside in the U.S.
* speak and read English
* access to a smart phone, tablet, or a computer with Internet access
* have or be willing to obtain email for study correspondence

Exclusion Criteria:

* cognitive impairment that significantly limits their ability to give informed consent, participate in the intervention, or complete study assessments as determined by an inability to correctly answer questions demonstrating study comprehension
* have a significant visual or hearing impairment that would prohibit their ability to participate in the interactive online intervention with accommodations
* report active suicidality or significant problems with alcohol or other drug use
* live in an institution

Primary outcomes:
measure: Change in physical health as assessed by the SF-36 General Health Subscale
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in physical health as assessed by the Pain Intensity scale
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in physical health as assessed by the Interference scale
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in physical health as assessed by the SCI Secondary Conditions Scale (SCI-SCS)
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in psychological health and wellbeing as assessed by the Patient Health Questionaire-8 (PHQ-8)
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in psychological health and wellbeing as assessed by the Generalized Anxiety Disorder (GAD-2) scale
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in psychological health and wellbeing as assessed by the 4-itemPerceived Stress Scale (PSS)
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in psychological health and wellbeing as assessed by the SCI-Qol Positive Affect and Well-being Scale
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in psychological health and wellbeing as assessed by the Diener Satisfaction with Life Scale (SWLS)
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in social health as assessed by the UCLA Loneliness scale
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in social health as assessed by the Spinal Cord Injury - Quality of Life Scale (SCI-QOL) Satisfaction with Participation Scale
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
Secondary outcomes:
measure: Change in self efficacy as assessed by the Generalized Self-Efficacy Scale (GSES)
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in self efficacy as assessed by the University of Washington Self-efficacy Scale(UW-SES)
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in health behaviors/behavioral symptoms as assessed by the Health Promoting Lifestyle Profile-II (HPLP-II)
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
measure: Change in health behaviors/behavioral symptoms as assessed by the SCI-specific Health Behavior Questionnaire (HBQ)
timeFrame: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )
Other outcomes:
Locations:
city: Houston
country: United States
facility: TIRR Memorial Hermann Spinal Cord Injury and Disability Research Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Susan Robinson-Whelen, PhD
role: PRINCIPAL_INVESTIGATOR
References: