Health Information for Persons With Spinal Cord Injury

The Washington University

Status: Not yet enrolling

Conditions: Spinal Cord Injuries (SCI)

Treatments: Behavioral: Secondary Health Conditions (SHC) text message group; Behavioral: Motivational text message group

Study type: Interventional

Funder types: Other

Identifiers

NCT07386522

1142299 (Other Identifier)

202402196

Details and patient eligibility

About

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].

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Secondary Health Conditions (SHC) text message group

Active Comparator group

Description:

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).

Treatment:

Behavioral: Secondary Health Conditions (SHC) text message group

Motivational text message group

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Motivational text message group