Clinical trial NCT05424172: Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching
Official title: Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone-Based Technology and E-coaching: A Proof-of-Concept SMART-Design Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Exercise
Telemedicine
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

With input from consumers and clinicians during in-person and remote focus groups, the investigators will gain information that can be used to develop and modify exercise and health monitoring apps to optimize usability and compliance. The investigators will ask a group of "expert" clinicians and researchers that are knowledgeable about SCI to identify the most important constructs to discuss during the focus groups. The focus groups will include various app stakeholders (individuals with SCI, caregivers, clinicians) to ensure diverse perspectives from all potential app users.

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Phase 2: Usability Testing (not a clinical trial)

Participants with SCI only

Aim 2: Conduct a usability study of custom apps to optimize their acceptability, appropriateness, and feasibility.

The investigators will assess the acceptability, appropriateness, and feasibility of the customized exercise app in persons with SCI, and determine the quality (i.e., engagement, functionality, aesthetics, information quality, and perceived benefits) of these apps. From usability metrics collected after participants with SCI completed a two-week trial using the app, the investigators can implement further changes to further optimize the app.

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Phase 3: Two-Stage SMART Trial (clinical trial)

Participants with SCI only

Aim 3: Conduct a proof-of-concept sequential multiple assignment randomized trial (SMART) study to determine the most effective adaptive interventions to improve exercise adherence and health and functional outcomes.

In Stage-I, the investigators will compare the effect of using (Group 1) commercially available, free to use, non-interactive smartphone health apps (a simplified version of Pt Pal) vs. (Group 2) a personalized, interactive app (Pt Pal), which allows for customizations for each individual. While both groups will be provided customized exercises at the beginning of the intervention, only those in Group 2 will get regular (i.e., bi-weekly/monthly) exercise updates based on their progress and Ecological Momentary Assessments (EMA) monitoring throughout Stage-I (weeks 1-12). In Stage-II (weeks 13-24), e-coaching will be added for participants who do not achieve at least 50% guideline adherence using these app-based interventions in Stage-I. The investigators will randomize participants who are not adherent to the exercise guidelines to either twice per month (Groups 1a/2a) or four times per month (Groups 1b/2b) e-coaching that utilizes SCI-specific EMA and motivational interviewing techniques. E-coaching in real-time using trained personnel will augment the initial intervention to support coping with barriers and action planning. Outcomes will be reassessed at the end of Stage-I (12 weeks) and Stage-II (24 weeks).

Aim 3.1: Compare effects of two app-based interventions on primary and secondary outcomes: Group 1 (customized exercise + non-interactive app) vs. Group 2 (customized exercise + interactive, customized app).

Aim 3.2: Compare effects of two augmented interventions on primary and secondary outcomes: Groups 1a and 2a (e-coaching twice per month) vs. Groups 1b and 2b (e-coaching four times per month).

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Exploratory Phase: (not a clinical trial)

Participants with SCI, caregivers, and clinicians

Exploratory Aim: Explore exercise protocols, questionnaire delivery, sensor types/setups, sensor parameters, and/or analysis techniques to optimally capture psychosocial, mobility, and other characteristics.

As needed, the investigators may trial variations of the questionnaires, sensors, and other parameters using to optimize the data collection procedures for Phases 1-3.

Eligibility criteria: Inclusion Criteria: Phase 1

* 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

Exclusion Criteria: Phase 1

* 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

Primary outcomes:
measure: Rate of Adherence to SCI exercise guidelines
timeFrame: 12 weeks
measure: Rate of Adherence to SCI exercise guidelines
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Six-Minute Walk/Push Test from Baseline to 12 weeks
timeFrame: From Baseline to 12 weeks
measure: Change in Six-Minute Walk/Push Test from 12 to 24 weeks
timeFrame: From 12 weeks to 24 weeks
measure: Change in Six-Minute Walk/Push Test from Baseline to 24 weeks
timeFrame: From Baseline to 24 weeks
measure: Change in Exercise Self-Efficacy from Baseline to 12 weeks
timeFrame: From Baseline to 12 weeks
measure: Change in Exercise Self-Efficacy from 12 to 24 weeks
timeFrame: From 12 weeks to 24 weeks
measure: Change in Exercise Self-Efficacy from Baseline to 24 weeks
timeFrame: From Baseline to 24 weeks
measure: Change in Spinal Cord Injury-Quality of Life Scales from Baseline to 12 Weeks
timeFrame: From Baseline to 12 weeks
measure: Change in Spinal Cord Injury-Quality of Life Scales from 12 to 24 Weeks
timeFrame: From 12 weeks to 24 weeks
measure: Change in Spinal Cord Injury-Quality of Life Scales from Baseline to 24 Weeks
timeFrame: From Baseline to 24 weeks
Other outcomes:
measure: Change in 10 Meter Walk or Wheelchair Propulsion Test from Baseline to 12 Weeks
timeFrame: From Baseline to 12 weeks
measure: Change in 10 Meter Walk or Wheelchair Propulsion Test from 12 to 24 Weeks
timeFrame: From 12 weeks to 24 weeks
measure: Change in 10 Meter Walk or Wheelchair Propulsion Test from Baseline to 24 Weeks
timeFrame: From Baseline to 24 weeks
measure: Change in Barriers to Physical Activity Questionnaire for People with Mobility Impairments from Baseline to 12 Weeks
timeFrame: From Baseline to 12 weeks
measure: Change in Barriers to Physical Activity Questionnaire for People with Mobility Impairments from 12 to 24 Weeks
timeFrame: From 12 weeks to 24 weeks
measure: Change in Barriers to Physical Activity Questionnaire for People with Mobility Impairments from Baseline to 24 Weeks
timeFrame: From Baseline to 24 weeks
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References: