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By invitation only Not applicable NCT07473258

DRIV - Health Online for People With Spinal Cord Injury

No applicable phase (e.g. observational)
Conditions: Spinal Cord Injury

Sponsor: Karolinska Institutet

trial.available_in: БГ
Overview
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.
Description
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: A topic-specific lecture (e.g., adapted physical activity, nutrition, stress management). Facilitated discussions based on a study-circle model. Structured goal-setting and behavioral-change strategies. Weekly home assignments and optional adapted exercise sessions. All course participants (regardless of research participation) receive identical program content. Study participants additionally complete standardized assessments at specified timepoints. Control Procedures Control participants receive no intervention during their 10-week control period and continue their usual activities. They complete the same baseline and 10-week assessments as the intervention group, allowing comparison of changes over an equivalent time frame. Once their control period ends, they are offered a place in the next DRIV course but are not included again as new study controls. Measurement Schedule Study participants complete assessments at the following timepoints: * T1 (Baseline): Prior to course start (or at the equivalent time for controls). * T2 (10 weeks): Immediately after the intervention period (or after 10 weeks on the waitlist for controls). * T3 (6-month follow-up): Six months after course completion (intervention group only). All assessments are self-administered digitally via REDCap. Participants in both groups wear an accelerometer for 7 days at T1 and T2; only intervention participants repeat this at T3. Data Collection Procedures * Survey invitations are distributed individually by email with unique coded links. * Participants self-measure height, weight, and waist circumference using standardized written instructions. * Accelerometers are mailed to participants with instructions and returned for data upload. * All questionnaire and accelerometer data are automatically labeled with the participant's study code.
Who can participate
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Interventions
DRIV Program
BEHAVIORAL
Locations 1
Sweden (1)
Rehab Station Stockholm
Stockholm
Technical details
Status
By invitation only
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
01.08.2025
Completion date
30.12.2026
Registry ID
NCT07473258
Source
clinicaltrials.gov
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