Health Information for Persons With Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Secondary Health Conditions (SHC) text message group, Motivational text message group.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries (SCI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reaching Persons With Spinal Cord Injury With Important Health Information Through a Text-messaging Intervention: Adaptation and Pilot Study
Overview
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.
Interventions
- Behavioral Secondary Health Conditions (SHC) text message group
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 tha - Behavioral Motivational text message group
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.
Primary outcome measures
- The Patient Activation Measure (PAM-13) [Time frame: 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) [Time frame: Baseline and up to 2 weeks post intervention]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
\- Current admission in a hospital or in-patient rehabilitation facility
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT07386522 · 202402196 · 1142299