Reaching Persons With Spinal Cord Injury With Important Health Information Through a Text-messaging Intervention: Adaptation and Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Patient Activation Measure (PAM-13)
研究概览
简要总结
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].
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- Current admission in a hospital or in-patient rehabilitation facility
研究组 & 干预措施
Secondary Health Conditions (SHC) text message group
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).
干预措施: Secondary Health Conditions (SHC) text message group (Behavioral)
Motivational text message group
A group provided 16-weeks of daily motivational text messages.
干预措施: Motivational text message group (Behavioral)
结局指标
主要结局
The Patient Activation Measure (PAM-13)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Kerri Morgan
Associate Professor of Occupational Therapy and Neurology, Director, Research Division of Occupational Therapy
Washington University School of Medicine