Spinal Cord Injuries (SCI)NCT07386522
Health Information for Persons With Spinal Cord Injury
A study testing Secondary Health Conditions (SHC) text message group and Motivational text message group in people with Spinal Cord Injuries (SCI), run by Washington University School of Medicine at 1 site in United States.
Trial summary
The goal of this pilot study is to design and feasibility test a mobile phone text messaging (SMS) self-management intervention for persons with spinal cord injury (PwSCI). The project will focus on providing a 16-week text messaging intervention on the secondary health conditions of bowel/bladder management, pain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- Secondary Health Conditions (SHC) text message group and Motivational text message group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of SCI
- At least 3 months from date of injury or illness
- Identify at least one secondary health condition (pain, pressure injury, bladder/bowel dysfunction, and psychosocial distress) that impacts daily life
- Live in the community
- English as primary language
- Ability and willingness to use their own smartphone to receive and respond to text messages for the 16-week study period
- Ability and willingness to participate in two full assessments and an additional four check ins during the 16-week study period
Who cannot join
- Current admission in a hospital or in-patient rehabilitation facility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63108
About this study
Official title: Reaching Persons With Spinal Cord Injury With Important Health Information Through a Text-messaging Intervention: Adaptation and Pilot Study
The goal of this pilot study is to design and feasibility test a mobile phone text messaging (SMS) self-management intervention for persons with spinal cord injury (PwSCI). The project will focus on providing a 16-week text messaging intervention on the secondary health conditions of bowel/bladder management, pain, pressure injury, and psychosocial health. Our hopes are to reduce the impact of secondary health conditions (SHC) for PwSCI.
The project hopes to test whether the developed self-management program will be feasible and superior to a control group. determine the feasibility and efficacy of the SMS intervention main questions the study aims to answer are:
Read more
Participants will:
Complete an initial assessment Participate in a 16-week text messaging program using their mobile phones Complete 4-week check-ins Complete a post assessment
The main question[s] it aims to answer [is/are]:
[primary hypothesis or outcome measure 1]? [primary hypothesis or outcome measure 2]? If there is a comparison group: Researchers will compare [arm information] to see if [insert effects].
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
Read the detailed description
The goal of this pilot study is to build and test a mobile health (mHealth) short message service (SMS) self-management intervention for persons with spinal cord injury.
- Conditions
- Spinal Cord Injuries (SCI)
- Being tested
- Secondary Health Conditions (SHC) text message group, Motivational text message group
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary Health Conditions (SHC) text message groupBehavioural
The Secondary Health Conditions (SHC) text message group will participate in a 16-week text message intervention in which they will receive and respond to text messages focused on SHC information. Each domain or 4-week period will include text messages on one SHC (psychosocial health, bowel and bladder management, pressure injury/skin management, and pain). Every 4 weeks the domain topic will change until all 4 topics have been covered. On Mondays-Thursdays participants will receive messages that don't require a return response and on Fridays participants will receive a total of 5 messages, three that will require a short response. The overall goal is to provide daily tips to help manage SHC.
Motivational text message groupBehavioural
The motivational text message group will participate in a 16-week text message intervention in which the participants will receive and respond to text messages that are motivational in nature. On Mondays-Thursdays they will receive messages that don't require a return response and on Fridays participants will receive a total of 3 messages, one of those requiring a return response.
| Study group | Role | What they receive |
|---|---|---|
| Secondary Health Conditions (SHC) text message group | Active comparator | A group provided 16-weeks of daily text messaging tips on four secondary health conditions (psychosocial health, bowel/bladder management, pressure injury/skin management, and pain). Receives: Behavioral: Secondary Health Conditions (SHC) text message group |
| Motivational text message group | Placebo comparator | A group provided 16-weeks of daily motivational text messages. Receives: Behavioral: Motivational text message group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Patient Activation Measure (PAM-13)
The Patient Activation Measure (PAM-13) assesses four levels of activation: (1) the patient is disengaged and overwhelmed, (2) the patient is becoming aware but still struggling, (3) the patient takes action, and (4) the patient maintains behaviors. The psychometric properties of the PAM-13 have been assessed in multiple healthcare settings. Raw PAM-13 scores can be transformed into a continuous (0-100) scale, where higher score represent higher levels of patient activation. In order to target self-management strategies, participants will proceed through these levels.
Measured: Baseline, every 4 weeks during 16-week intervention and up to 2 weeks post intervention
Self-Care in Spinal Cord Injuries Inventory (SC-SCII) and Self-Care Self-Efficacy Scale in Spinal Cord Injuries (SCSES-SCI)
The Self-Care in Spinal Cord Injuries Inventory and Self-Care Self-Efficacy Scale in Spinal Cord Injuries are valid and reliable instruments designed to assess self-care behaviors in individuals with spinal cord injuries. There are four self-care dimensions: self-care maintenance, self-care monitoring, self-care management and self-care self-efficacy.
Scoring uses a 5-point rating scale. Higher scores show better self-care.
Measured: Baseline and up to 2 weeks post intervention
Secondary outcomes (2)
Spinal Cord Injury - Quality of Life Independence measurement system (SCI-QOL)
The SCI-QOL is designed as a multifaceted system for measuring patient reported outcomes across a wide variety of functioning. The SCI-QOL consists of a core set of PROMIS/Neuro-QOL items that have been optimized for people with SCI. The Pain Interference (10-item), Positive Affect and Well-being (10-item), Anxiety (9-item), Resilience (8-item), Bladder Management Difficulties (8-item), Bowel Management Difficulties (9-item), and Pressure Ulcers (7-item) item banks will be the components used in this study. Each item bank is calibrated to a mean score of 50 with a standard deviation of 10, indicating normal functioning. Higher scores on the SCI-QOL reflect greater levels of the constructs being measured.
Measured: Baseline and up to 2 weeks post intervention
PROMIS Item Bank v.1.0 Emotional Distress and Depression (Short Form 8b)
The PROMIS item bank for emotional distress - depression is a self-report measure designed to assess the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale from "never (1) to "always" (5). It consists of 8 items that evaluate symptoms such as feelings of worthlessness, hopelessness, and loss of interest in activities. PROMIS instruments are scored using item-level calibrations. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline and up to 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start5 Feb 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Kerri Morgan, Washington University School of Medicine
- Investigators
- Kerri A Morgan, PhD, Principal investigator, Washington University School of Medicine - Program in OT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386522
- Sponsor's protocol ID
- 202402196
- Other IDs
- 1142299
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Persons With Spinal Cord Injury With Important Health Information Through a Text-messaging Intervention: Adaptation and Pilot Study
- ClinicalTrials.gov ID
- NCT07386522
- Acronym / sponsor ID
- 202402196
- Conditions
- Spinal Cord Injuries (SCI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to design and feasibility test a mobile phone text messaging (SMS) self-management intervention for persons with spinal cord injury (PwSCI). The project will focus on providing a 16-week text messaging intervention on the secondary health conditions of bowel/bladder management, pain, pressure injury, and psychosocial health. Our hopes are to reduce the impact of secondary health conditions (SHC) for PwSCI.
The project hopes to test whether the developed self-management program will be feasible and superior to a control group. determine the feasibility and efficacy of the SMS intervention main questions the study aims to answer are:
Participants will:
Complete an initial assessment Participate in a 16-week text messaging program using their mobile phones Complete 4-week check-ins Complete a post assessment
The main question[s] it aims to answer [is/are]:
[primary hypothesis or outcome measure 1]? [primary hypothesis or outcome measure 2]? If there is a comparison group: Researchers will compare [arm information] to see if [insert effects].
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].
Detailed description
The goal of this pilot study is to build and test a mobile health (mHealth) short message service (SMS) self-management intervention for persons with spinal cord injury.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Secondary Health Conditions (SHC) text message group | Active comparator | Behavioral: Secondary Health Conditions (SHC) text message groupA group provided 16-weeks of daily text messaging tips on four secondary health conditions (psychosocial health, bowel/bladder management, pressure injury/skin management, and pain). |
| Motivational text message group | Placebo comparator | Behavioral: Motivational text message groupA group provided 16-weeks of daily motivational text messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Diagnosis of SCI
- At least 3 months from date of injury or illness
- Identify at least one secondary health condition (pain, pressure injury, bladder/bowel dysfunction, and psychosocial distress) that impacts daily life
- Live in the community
Key exclusion criteria (1 listed)
- Current admission in a hospital or in-patient rehabilitation facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secondary Health Conditions (SHC) text message groupThe Secondary Health Conditions (SHC) text message group will participate in a 16-week text message intervention in which they will receive and respond to text messages focused on SHC information. Each domain or 4-week period will include text messages on one SHC (psychosocial health, bowel and bladder management, pressure injury/skin management, and pain). Every 4 weeks the domain topic will change until all 4 topics have been covered. On Mondays-Thursdays participants will receive messages that don't require a return response and on Fridays participants will receive a total of 5 messages, three that will require a short response. The overall goal is to provide daily tips to help manage SHC. | Behavioural | Secondary Health Conditions (SHC) text message group |
| Motivational text message groupThe motivational text message group will participate in a 16-week text message intervention in which the participants will receive and respond to text messages that are motivational in nature. On Mondays-Thursdays they will receive messages that don't require a return response and on Fridays participants will receive a total of 3 messages, one of those requiring a return response. | Behavioural | Motivational text message group |
Primary outcome
The Patient Activation Measure (PAM-13)
Time frame: Baseline, every 4 weeks during 16-week intervention and up to 2 weeks post intervention
The Patient Activation Measure (PAM-13) assesses four levels of activation: (1) the patient is disengaged and overwhelmed, (2) the patient is becoming aware but still struggling, (3) the patient takes action, and (4) the patient maintains behaviors. The psychometric properties of the PAM-13 have been assessed in multiple healthcare settings. Raw PAM-13 scores can be transformed into a continuous (0-100) scale, where higher score represent higher levels of patient activation. In order to target self-management strategies, participants will proceed through these levels.
Self-Care in Spinal Cord Injuries Inventory (SC-SCII) and Self-Care Self-Efficacy Scale in Spinal Cord Injuries (SCSES-SCI)
Time frame: Baseline and up to 2 weeks post intervention
The Self-Care in Spinal Cord Injuries Inventory and Self-Care Self-Efficacy Scale in Spinal Cord Injuries are valid and reliable instruments designed to assess self-care behaviors in individuals with spinal cord injuries. There are four self-care dimensions: self-care maintenance, self-care monitoring, self-care management and self-care self-efficacy. Scoring uses a 5-point rating scale. Higher scores show better self-care.
2 secondary outcomes
Spinal Cord Injury - Quality of Life Independence measurement system (SCI-QOL)
Time frame: Baseline and up to 2 weeks post intervention
PROMIS Item Bank v.1.0 Emotional Distress and Depression (Short Form 8b)
Time frame: Baseline and up to 2 weeks post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerri A Morgan, PhD principal investigator
Washington University School of Medicine - Program in OT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secondary Health Conditions (SHC) text message group and Motivational text message group in people with Spinal Cord Injuries (SCI), run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerri A Morgan, PhD (314-286-1659, morgank@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Patient Activation Measure (PAM-13) (time frame: Baseline, every 4 weeks during 16-week intervention and up to 2 weeks post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.