Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone-Based Technology and E-coaching: A Proof-of-Concept SMART-Design Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Rate of Adherence to SCI exercise guidelines
研究概览
简要总结
The goal of this research is to increase physical activity among individuals with a spinal cord injury (SCI) through a customized, interactive smartphone-based health app and e-coaching using three phases: (1) leading focus groups of potential app users and clinicians to gain information regarding health apps preferences for optimal consumer use, (2) conducting a usability study of the customized app to determine the quality and implement further changes for optimization, and (3) conducting a sequential multiple assignment randomized trial (SMART) to determine the most effective adaptive intervention to improve exercise adherence. A SMART trial will be used to determine when and how to adapt dosage, timing, and delivery to increase adherence and address low-response behaviors. In Stage-I, the investigators will compare outcomes among participants using a generic, non-interactive exercise app (Group 1) to a customized, interactive app that can gain information through frequent Ecological Momentary Assessments (EMA) that will be used to modify each participant's exercise programs (Group 2). After 12 weeks, participants who are not meeting the exercise guidelines at least 50% of the time will also be asked to participate in motivational interviewing-based e-coaching either two or four times per month in addition to their originally assigned intervention (Stage-II). By completing these three phases, this project addresses deficiencies in exercise levels and compliance by implementing an individualized exercise prescription, an adaptive intervention for low responders, a way to address barriers to exercise, and a free smartphone app for broad implementation.
详细描述
This study will investigate the effect of a low-cost, multi-component, individualized, and adaptive telehealth program on (1) adherence to exercise guidelines by community-dwelling adults with spinal cord injury (SCI) and (2) on improving health and functional outcomes categorized by the World Health Organization's International Classification of Functioning, Disability and Health (ICF) model.
The proposed trial consists of three phases:
Phase 1: Technology Development (not a clinical trial)
Participants with SCI, caregivers, and clinicians
Aim 1: Obtain input from consumers on the modifications needed to customize smartphone-based apps to assess and facilitate exercise adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual with diagnosis of SCI, formal or informal caregiver of an individual with an SCI, or clinician that regularly sees individuals with SCI
- •18-80 years of age
- •English-speaking
- •Willing to download the study apps
排除标准
- •Severe visual or cognitive problems that would affect the ability to complete the study
- •Does not own, or is unable to use a smartphone
- •Inclusion Criteria: Phase 2 and 3
- •Individual with diagnosis of SCI, complete (only paraplegia) or incomplete, cervical C3- C4 and below
- •18-80 years of age
- •English-speaking
- •Use a wheelchair as primary means of mobility or walk with or without assistive equipment
- •At least 1-year post-SCI
- •Not adhering to SCI-specific exercise guidelines as ascertained by self-report or during structured phone interview
- •Interested in increasing exercise levels
- •Ownership of a smartphone that can be used for the study and has a data plan
- •Willing to successfully download and learn to use the study apps
- •Able and willing to give written consent and comply with study procedures, including multiple in person follow-up visits
- •Exclusion Criteria: Phase 2 and 3
- •Trauma or surgery in the past three months
- •An active stage 3 or 4 pressure ulcer
- •Medically unstable to perform the home-based exercise as determined by Dr. Chen and his team, the evaluating physical therapist, or the participants' primary care physician.
- •Unable to use at least one set of extremities to exercise
- •Enrolled in a structured exercise program over the past three months
- •Severe visual or cognitive problems that would affect the ability to complete the study
- •Does not own, or is unable to use a smartphone
研究组 & 干预措施
Stage-I: Self Monitoring Exercise Using a Health App
Participants will be randomized into one of two groups: Group 1 (self monitoring using a non-interactive app), and Group 2 (self monitoring using an interactive app). Participants in both groups will be provided a customized exercise program to complete over the duration of the study. Within either app, participants will be able to view assigned exercises, log additional exercises completed, complete questionnaires as needed, and access additional resources. Participants will use their own smartphone to receive the health app. Participants will continue using their Stage-I app intervention for the entire duration of the study (weeks 1-24).
干预措施: Stage-I, Group 1: Self monitoring using Non-interactive App (Behavioral)
Stage-I: Self Monitoring Exercise Using a Health App
Participants will be randomized into one of two groups: Group 1 (self monitoring using a non-interactive app), and Group 2 (self monitoring using an interactive app). Participants in both groups will be provided a customized exercise program to complete over the duration of the study. Within either app, participants will be able to view assigned exercises, log additional exercises completed, complete questionnaires as needed, and access additional resources. Participants will use their own smartphone to receive the health app. Participants will continue using their Stage-I app intervention for the entire duration of the study (weeks 1-24).
干预措施: Stage-I, Group 2: Self monitoring using Interactive App (Behavioral)
Stage-II: Strategy to Address Non-Adherence
After 12 weeks, the participants will be categorized as adherents or non-adherents based on their rates of adhering to the SCI exercise guidelines during Stage-I. Non-adherents (those who met the exercise guidelines <50% of the weeks) will be randomized to receive an augmented intervention of motivational interviewing-based e-coaching (2x per month or 4x per month) in addition to their Stage-I assigned app for 12 weeks (weeks 13-24) to further increase rates of exercise. All non-adherents who will be assigned to the e-coaching interventions will be asked to complete at least daily EMA surveys. A coach who is trained in motivational interviewing will review the EMA data and work collaboratively with participants to identify barriers and facilitators and develop individualized strategies to improve exercise adherence. Adherents (those who met the exercise guidelines >50% of the weeks) will continue with only their Stage-I assigned app intervention throughout Stage-II.
干预措施: Stage-II, Groups 1a/2a: E-Coaching 1x per month (Behavioral)
Stage-II: Strategy to Address Non-Adherence
After 12 weeks, the participants will be categorized as adherents or non-adherents based on their rates of adhering to the SCI exercise guidelines during Stage-I. Non-adherents (those who met the exercise guidelines <50% of the weeks) will be randomized to receive an augmented intervention of motivational interviewing-based e-coaching (2x per month or 4x per month) in addition to their Stage-I assigned app for 12 weeks (weeks 13-24) to further increase rates of exercise. All non-adherents who will be assigned to the e-coaching interventions will be asked to complete at least daily EMA surveys. A coach who is trained in motivational interviewing will review the EMA data and work collaboratively with participants to identify barriers and facilitators and develop individualized strategies to improve exercise adherence. Adherents (those who met the exercise guidelines >50% of the weeks) will continue with only their Stage-I assigned app intervention throughout Stage-II.
干预措施: Stage-II, Groups 1b/2b: E-Coaching 2x per month (Behavioral)
结局指标
主要结局
Rate of Adherence to SCI exercise guidelines
时间窗: 24 weeks
Using app-based data and self-report, the investigators will determine if each participant met the SCI aerobic exercise guidelines (moderate to vigorous aerobic exercise for at least 20 minutes twice per week) for each week of the study. The investigators will total the number of weeks in which the participants achieved adherence and calculate the percentage of adherence over each 12-week stage. An overall adherence rate of 50% will be regarded as meeting exercise guidelines for the stage.
次要结局
- Change in Spinal Cord Injury-Quality of Life Scales from Baseline to 12 Weeks(From Baseline to 12 weeks)
- Change in Six-Minute Walk/Push Test from Baseline to 12 weeks(From Baseline to 12 weeks)
- Change in Exercise Self-Efficacy from Baseline to 12 weeks(From Baseline to 12 weeks)
- Change in Exercise Self-Efficacy from 12 to 24 weeks(From 12 weeks to 24 weeks)
- Change in Six-Minute Walk/Push Test from 12 to 24 weeks(From 12 weeks to 24 weeks)
- Change in Six-Minute Walk/Push Test from Baseline to 24 weeks(From Baseline to 24 weeks)
- Change in Exercise Self-Efficacy from Baseline to 24 weeks(From Baseline to 24 weeks)
- Change in Spinal Cord Injury-Quality of Life Scales from 12 to 24 Weeks(From 12 weeks to 24 weeks)
- Change in Spinal Cord Injury-Quality of Life Scales from Baseline to 24 Weeks(From Baseline to 24 weeks)
研究者
Arun Jayaraman, PT, PhD
Principal Investigator
Shirley Ryan AbilityLab