Health Information for Persons With Spinal Cord Injury

Официальное название

Reaching Persons With Spinal Cord Injury With Important Health Information Through a Text-messaging Intervention: Adaptation and Pilot Study

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• The Patient Activation Measure (PAM-13) [Срок оценки: 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) [Срок оценки: Baseline and up to 2 weeks post intervention]

Вторичные конечные точки (2)

• Spinal Cord Injury - Quality of Life Independence measurement system (SCI-QOL) [Срок оценки: Baseline and up to 2 weeks post intervention]
• PROMIS Item Bank v.1.0 Emotional Distress and Depression (Short Form 8b) [Срок оценки: Baseline and up to 2 weeks post intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT07386522 · 202402196 · 1142299

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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