DRIV - Health Online for People With Spinal Cord Injury

NCT07473258 | Enrolling By Invitation

• 1 other identifier: 2023-01754-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injury

Keywords

clinical trial

Outcome Measures

Primary Outcomes (4)

• Change in Physical Activity (measured by wrist-worn accelerometer)

  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.

  Baseline to 10 weeks

• Change in Self-Reported Lifestyle Behaviors (using standardized lifestyle questionnaire)

  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.

  Baseline to 10 weeks

• Change in Well-Being (using the International SCI Quality of Life Basic Dataset)

  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.

  Baseline to 10 weeks

• Maintenance of Lifestyle and Well-Being Improvements at 6 Months

  Sustained change in lifestyle behaviors and well-being at 6-month follow-up using the same questionnaires as above.

  10 weeks to 6 months

Other Outcomes (1)

• Change in Body Weight (kg)

  Baseline to 10 weeks

Study Arms (2)

Arm 1: Intervention - DRIV Program

EXPERIMENTAL

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.

Behavioral: DRIV Program

Arm 2: Waitlist Control

NO INTERVENTION

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).

Interventions

DRIV Program BEHAVIORAL

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.

Also known as: Arm 1 Intervention

Arm 1: Intervention - DRIV Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Rehab Station Stockholm

Stockholm, Sweden

Location

Related Links

• the homepage for the project

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Assistant professor

Model Details: Participants are allocated to one of two non-randomized parallel groups. Individuals invited to participate in the immediate 10-week DRIV online health-promotion program form the intervention group. Individuals who remain on the waitlist and do not receive any intervention during the same 10-week period form the waitlist control group. After completing the control period and follow-up assessments, waitlist participants are offered the DRIV program. This design allows comparison between the intervention and control groups over an equivalent 10-week timeframe.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: March 16, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)