Health Information for Persons With Spinal Cord Injury

NCT07386522 | Recruiting

• 2 other identifiers: 2024021961142299
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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, 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 \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Conditions

Spinal Cord Injuries (SCI)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and up to 2 weeks post intervention

Secondary Outcomes (2)

• Spinal Cord Injury - Quality of Life Independence measurement system (SCI-QOL)

  Baseline and up to 2 weeks post intervention

• PROMIS Item Bank v.1.0 Emotional Distress and Depression (Short Form 8b)

  Baseline and up to 2 weeks post intervention

Study Arms (2)

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).

Behavioral: Secondary Health Conditions (SHC) text message group

Motivational text message group

PLACEBO COMPARATOR

A group provided 16-weeks of daily motivational text messages.

Behavioral: Motivational text message group

Interventions

Secondary Health Conditions (SHC) text message group BEHAVIORAL

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.

Secondary Health Conditions (SHC) text message group

Motivational text message group BEHAVIORAL

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.

Motivational text message group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \- Current admission in a hospital or in-patient rehabilitation facility

Sponsors & Collaborators

• Washington University School of Medicine: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

RECRUITING

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 Officials

• Kerri A Morgan, PhD

  Washington University School of Medicine - Program in OT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerri A Morgan, PhD

CONTACT

314-286-1659; morgank@wustl.edu

Kim A Walker, OTD

CONTACT

314-273-7010; walker.k@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Occupational Therapy and Neurology, Director, Research Division of Occupational Therapy

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)