跳至主要内容
临床试验/NCT06227000
NCT06227000进行中(未招募)不适用

Living Longer and Stronger With Spinal Cord Injury: An Online Program for Promoting Healthy Aging

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
180
试验地点
2
主要终点
Change in psychological health and wellbeing as assessed by the Generalized Anxiety Disorder (GAD-2) scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Control Group

Active Comparator

干预措施: Control (Behavioral)

Living Longer and Stronger (LLS) intervention

Experimental

干预措施: Living Longer and Stronger with SCI (Behavioral)

结局指标

主要结局

Change in psychological health and wellbeing as assessed by the Generalized Anxiety Disorder (GAD-2) scale

时间窗: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

This is a 2 item questionnaire and each is scored from 0(not at all) to 3(nearly every day), for a maximum score of 6 higher score indicating worse outcome

Change in psychological health and wellbeing as assessed by the SCI-Qol Positive Affect and Well-being Scale

时间窗: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

This is a 10 item questionnaire, and each is scored from from 1 (never) to 5 (always). Items are summed to create a raw score. Raw scores are then converted to an IRT-based T-score using provided look-up tables. T-scores range from 26.7 to 68.6 with higher scores representing more positive affect and well-being.

Change in physical health as assessed by the SF-36 General Health Subscale

时间窗: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

a 5-item scale of self-perceived health. The subscale consists of a single-item rating of health and four additional items reflecting perceived current health, resistance to illness and health outlook. Individual item responses range from 1-5. To score, select items (1, 3, and 5) are recoded so that higher scores indicate better health. The 5 items are then summed and transformed to a 0-100 scale with higher scores reflecting better health.

Change in physical health as assessed by the Pain Intensity scale

时间窗: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

This consists of one item assessing pain intensity/severity rated on a 11-point scale ranging from 0 (no pain) to 10 (pain so severe you couldn't stand it), higher score indicting worse pain

Change in physical health as assessed by the SCI Secondary Conditions Scale (SCI-SCS)

时间窗: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

This is a 16 item questionnaire and each item scores range from 0 (not experienced or insignificant problem) to 3 (significant or chronic problem). Items are summed with a potential score range of 0-48 with higher scores reflecting more severe secondary health conditions.

Change in psychological health and wellbeing as assessed by the Patient Health Questionaire-8 (PHQ-8)

时间窗: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

This is an 8 item questionnaire and each is scored from 0(not at all) to 3(nearly every day), for a maximum score of 24 higher score indicating worse outcome

Change in physical health as assessed by the Interference scale

时间窗: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

This is a 1 item questionnaire that is scored on a linear scale from 0 (no interference)-10 (extreme interference), higher score indicting worse outcome

Change in psychological health and wellbeing as assessed by the Diener Satisfaction with Life Scale (SWLS)

时间窗: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

This is a 4 item questionnaire and each is scored on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). Scores are summed resulting in a scale score ranging from 4 to 28 with higher scores representing greater life satisfaction.

Change in psychological health and wellbeing as assessed by the 4-itemPerceived Stress Scale (PSS)

时间窗: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

This is a 4 item questionnaire and questions 1 and 4 are scored from 0(never) to 4(very often) , and questions 2 and 3 are scored from 0(very often) to 4 (never) for a maximum score of 16 higher score indicating worse outcome

Change in social health as assessed by the UCLA Loneliness scale

时间窗: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

This is a 3 item questionnaire and each is scored from 1(hardly ever) to 3(often) for a maximum score of 9 higher score indicating worse outcome

Change in social health as assessed by the Spinal Cord Injury - Quality of Life Scale (SCI-QOL) Satisfaction with Participation Scale

时间窗: Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention )

This is a 10 item questionnaire and each is scored from 1(not at all) to 5(very much ) with the scale direction depending on whether the item is positively or negatively worded. Item scores are summed to create a raw score which is then converted to an IRT-based T-score using look-up tables. T-scores range from 28.3 to 60.5 with higher scores representing more satisfaction with social roles and activities.

次要结局

  • Change in self efficacy as assessed by the University of Washington Self-efficacy Scale(UW-SES)(Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention ))
  • Change in self efficacy as assessed by the Generalized Self-Efficacy Scale (GSES)(Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention ))
  • Change in health behaviors/behavioral symptoms as assessed by the Health Promoting Lifestyle Profile-II (HPLP-II)(Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention ))
  • Change in health behaviors/behavioral symptoms as assessed by the SCI-specific Health Behavior Questionnaire (HBQ)(Baseline, end of intervention (8 weeks after baseline), follow up (4 months after end of intervention ))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Robinson-Whelen

Adjunct Associate Professor

The University of Texas Health Science Center, Houston

研究点 (2)

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