Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:45 AM
Study NCT ID:
NCT07473258
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-03-16
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DRIV - Health Online for People With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Body Weight (kg)', 'timeFrame': 'Baseline to 10 weeks', 'description': 'Self-reported body weight measured at home in kilograms. Reported as change from baseline'}], 'primaryOutcomes': [{'measure': 'Change in Physical Activity (measured by wrist-worn accelerometer)', 'timeFrame': 'Baseline to 10 weeks', 'description': '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.'}, {'measure': 'Change in Self-Reported Lifestyle Behaviors (using standardized lifestyle questionnaire)', 'timeFrame': 'Baseline to 10 weeks', 'description': '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.'}, {'measure': 'Change in Well-Being (using the International SCI Quality of Life Basic Dataset)', 'timeFrame': 'Baseline to 10 weeks', 'description': '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.'}, {'measure': 'Maintenance of Lifestyle and Well-Being Improvements at 6 Months', 'timeFrame': '10 weeks to 6 months', 'description': 'Sustained change in lifestyle behaviors and well-being at 6-month follow-up using the same questionnaires as above.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clinical trial'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://spinalis.se/driv/', 'label': 'the homepage for the project'}]}, 'descriptionModule': {'briefSummary': '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:\n\nDoes 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?\n\nResearchers 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).\n\nParticipants will:\n\nAttend 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).\n\nComplete 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.\n\nWear 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.', 'detailedDescription': "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.\n\nStudy 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.\n\nParticipants are not blinded to their group assignment, as the intervention consists of an educational course requiring active engagement.\n\nIntervention Procedures\n\nThe intervention is the 10-week DRIV online course, delivered via Zoom. Each weekly session includes:\n\nA topic-specific lecture (e.g., adapted physical activity, nutrition, stress management).\n\nFacilitated discussions based on a study-circle model. Structured goal-setting and behavioral-change strategies. Weekly home assignments and optional adapted exercise sessions.\n\nAll course participants (regardless of research participation) receive identical program content. Study participants additionally complete standardized assessments at specified timepoints.\n\nControl 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.\n\nMeasurement Schedule\n\nStudy participants complete assessments at the following timepoints:\n\n* T1 (Baseline): Prior to course start (or at the equivalent time for controls).\n* T2 (10 weeks): Immediately after the intervention period (or after 10 weeks on the waitlist for controls).\n* T3 (6-month follow-up): Six months after course completion (intervention group only).\n\nAll 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.\n\nData Collection Procedures\n\n* Survey invitations are distributed individually by email with unique coded links.\n* Participants self-measure height, weight, and waist circumference using standardized written instructions.\n* Accelerometers are mailed to participants with instructions and returned for data upload.\n* All questionnaire and accelerometer data are automatically labeled with the participant's study code.\n\nNo identifiable data are stored within the analytic dataset. The code key linking identities to study codes is stored separately by the PI in secure, locked storage.\n\nData Management Coded data from REDCap and accelerometers are exported to a secure institutional OneDrive project folder. Only authorized research team members have access. Data integrity is monitored through routine checks for completeness, timestamp accuracy, and device-return compliance. Any discrepancies are documented and resolved prior to analysis.\n\nStatistical Approach\n\nData analysis will follow these steps:\n\n1. Descriptive analyses Summaries of baseline characteristics and distribution checks for all continuous and categorical variables.\n2. Within-group analyses Change over time within the intervention group (T1→T2 and T1→T3) using appropriate paired methods depending on variable type and distribution.\n3. Between-group comparison at 10 weeks Comparison of change from T1→T2 between intervention and control participants to distinguish intervention-related effects from natural variation.\n\nExploratory analyses\n\n1. Associations between baseline characteristics and degree of change. Relationships between changes in different domains (e.g., self-efficacy vs. physical activity).\n\n Sensitivity analyses for missing data or partial adherence.\n2. Analyses are primarily exploratory due to the multifactorial outcome structure and modest sample size.\n\nSample Size Considerations The study aims to recruit approximately 30 intervention participants and 30 controls across multiple course iterations. This sample size is considered feasible and adequate for detecting meaningful changes in key behavioral and psychosocial measures based on effect sizes reported in previous SCI health-behavior studies. Recruitment continues until target numbers are achieved.\n\nParticipant Flow and Adherence Tracking Adherence to program components (session attendance, assignment completion) is recorded through weekly logs maintained by the course leader. Completion of T1-T2-T3 assessments is monitored through REDCap timestamps. Dropout or non-completion is documented with reason if provided.\n\nEthical and Data-Protection Procedures\n\nAll participants provide written informed consent prior to data collection. The intervention is voluntary and declining research participation does not restrict course participation.\n\nAll handling of personal data complies with GDPR and institutional policies. Risks are minimal, limited to potential discomfort reflecting on lifestyle habits or wearing an activity monitor."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n* 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).\n* Able to provide informed consent and complete self-assessment questionnaires (no severe cognitive impairment that would hinder participation).\n* Sufficient Swedish language skills and internet access to participate in weekly online group sessions via video.\n\nExclusion Criteria:\n\n* 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).'}, 'identificationModule': {'nctId': 'NCT07473258', 'acronym': 'DRIV', 'briefTitle': 'DRIV - Health Online for People With Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'DRIV - Health Online for People With a Spinal Cord Injury', 'orgStudyIdInfo': {'id': '2023-01754-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Intervention - DRIV Program', 'description': '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.', 'interventionNames': ['Behavioral: DRIV Program']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 2: Waitlist Control', 'description': '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': [{'name': 'DRIV Program', 'type': 'BEHAVIORAL', 'otherNames': ['Arm 1 Intervention'], 'description': '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.', 'armGroupLabels': ['Arm 1: Intervention - DRIV Program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Rehab Station Stockholm', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual Participant Data (IPD) will not be shared because the study involves a small and specific population-adults living with long-term spinal cord injury-making it difficult to fully anonymize the data. Sharing IPD could risk compromising participant confidentiality, especially given the sensitive nature of health-related information and the group-based format of the intervention. Additionally, the study was not designed with external data sharing in mind, and participants were not asked to consent to such sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Assistant professor', 'investigatorFullName': 'Tobias Holmlund', 'investigatorAffiliation': 'Karolinska Institutet'}}}}