DRIV - Health Online for People With a Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Physical Activity (measured by wrist-worn accelerometer)
研究概览
简要总结
The goal of this clinical trial is to learn if a 10-week web-based health promotion program ("DRIV") can improve healthy lifestyle habits and overall well-being in adults living with long-term spinal cord injury (SCI). The main questions it aims to answer are:
Does participating in the online course lead to healthier lifestyle behaviors (for example, more physical activity and a better diet) and improved self-reported health for people with SCI? Are any improvements in health habits or well-being maintained six months after completing the program?
Researchers will compare participants who take the 10-week DRIV course to those on a waitlist (no intervention during that period) to see if any changes in lifestyle or health outcomes are due to the program (and not just time or other factors).
Participants will:
Attend a 1-hour group session online (via video) each week for 10 weeks, covering topics like exercise, nutrition, stress management, and goal setting (this is the intervention for the course group; waitlist group has no sessions during this time).
Complete health questionnaires at the start of the study and after 10 weeks (all participants), and again 6 months after the course for those who received the intervention, to report on their lifestyle habits, physical and mental health, and goal achievement.
Wear a wrist activity monitor (accelerometer) for 7 days at the beginning and 7 days at the end of the 10-week period to objectively measure physical activity levels.
详细描述
Overview This study evaluates the DRIV program, a 10-week web-based health-promotion course designed for individuals living long-term with spinal cord injury (SCI). The Detailed Description below outlines the study's operational procedures, design, data-collection flow, and analytic approach. It intentionally avoids content already provided in sections such as background, significance, eligibility criteria, and outcome measures.
Study Design The study uses a prospective intervention design with a waitlist control group. All individuals who register for the DRIV course are placed on a waitlist. For each course cycle, 8-12 individuals are invited to participate in that round and make up the intervention cohort. Individuals remaining on the waitlist are invited to serve as controls, with the guarantee that they will later be offered participation in a future course cycle.
Participants are not blinded to their group assignment, as the intervention consists of an educational course requiring active engagement.
Intervention Procedures
The intervention is the 10-week DRIV online course, delivered via Zoom. Each weekly session includes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
No masking is used. Because the intervention involves an interactive online course, both participants and investigators know whether the participant is receiving the program or waiting.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 years or older) living with a long-term spinal cord injury (acquired or congenital) and "aging with the injury" (i.e., have lived many years with SCI).
- •Have registered interest in participating in the 10-week web-based health promotion program "DRIV - hälsa online för dig med ryggmärgsskada" (health online for people with SCI).
- •Able to provide informed consent and complete self-assessment questionnaires (no severe cognitive impairment that would hinder participation).
- •Sufficient Swedish language skills and internet access to participate in weekly online group sessions via video.
排除标准
- •Individuals with severe psychiatric conditions that would interfere with active participation in a group health program (unmanaged mental illness preventing engagement in the online sessions).
研究组 & 干预措施
Arm 1: Intervention - DRIV Program
Participants assigned to this arm take part in the 10-week DRIV web-based health-promotion program. The course consists of weekly 1-hour group video sessions led by a trained course leader. Each week covers a specific lifestyle-related topic relevant to people living with spinal cord injury (e.g., adapted physical activity, healthy eating, stress management, recovery, motivation, and habit formation). Sessions include presentations, guided discussions, and opportunities for peer support. Participants set a personal health goal at baseline and complete weekly home exercises-such as self-monitoring behaviors or practicing course strategies-to reinforce learning between sessions.
干预措施: DRIV Program (Behavioral)
Arm 2: Waitlist Control
Participants assigned to the waitlist control group do not receive the DRIV program during the initial 10-week study period. They continue their usual routines and complete the same assessments as the intervention group at baseline and after 10 weeks. After finishing their role as controls, they are offered participation in the DRIV program during the next available course cycle (but are not reassigned as study participants).
结局指标
主要结局
Change in Physical Activity (measured by wrist-worn accelerometer)
时间窗: Baseline to 10 weeks
Physical activity intensity and duration measured using a 7-day wrist accelerometer at baseline and after the 10-week intervention. Values will be summarized as average daily minutes of moderate-to-vigorous physical activity.nt is conducted six months after the program to evaluate sustained effects.
Change in Self-Reported Lifestyle Behaviors (using standardized lifestyle questionnaire)
时间窗: Baseline to 10 weeks
Self-reported changes in diet, physical activity, sleep, stress, and tobacco/alcohol use using national public-health lifestyle indicator questions. Scores will be summarized as change from baseline.
Change in Well-Being (using the International SCI Quality of Life Basic Dataset)
时间窗: Baseline to 10 weeks
Self-reported satisfaction with general well-being, physical health, and psychological health on a 0-10 scale. Higher scores indicate better well-being. Reported as the change from baseline.
Maintenance of Lifestyle and Well-Being Improvements at 6 Months
时间窗: 10 weeks to 6 months
Sustained change in lifestyle behaviors and well-being at 6-month follow-up using the same questionnaires as above.
次要结局
未报告次要终点
研究者
Tobias Holmlund
PhD, Assistant professor
Karolinska Institutet