Improving Adherence to Spinal Cord Injury Exercise Guidelines Using Smartphone Technology and E-coaching

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Behavioral: Stage-II, Groups 1a/2a: E-Coaching 1x per month; Behavioral: Stage-I, Group 2: Self monitoring using Interactive App; Behavioral: Stage-II, Groups 1b/2b: E-Coaching 2x per month; Behavioral: Stage-I, Group 1: Self monitoring using Non-interactive App

Study type: Interventional

Funder types: Other

Identifiers

NCT05424172

90SIMS0015 (Other Grant/Funding Number)

STU00216188

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Stage-I: Self Monitoring Exercise Using a Health App

Experimental group

Description:

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).

Treatment:

Behavioral: Stage-I, Group 1: Self monitoring using Non-interactive App

Behavioral: Stage-I, Group 2: Self monitoring using Interactive App

Stage-II: Strategy to Address Non-Adherence

Experimental group

Description:

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.

Treatment:

Behavioral: Stage-II, Groups 1b/2b: E-Coaching 2x per month

Behavioral: Stage-II, Groups 1a/2a: E-Coaching 1x per month