Interactive Telehealth for Wheelchair Users

NCT04266808 | Unknown FDA Device

• 1 other identifier: 5R44AG059275-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

During typical daily activity, people with established spinal cord injury perform significantly fewer pressure-relief maneuvers than the recommended frequency while overestimating their adherence on recall surveys of pressure relief activity. The rate of pressure ulcer recurrence in individuals with a prior ulcer is 44% in those with surgical repair and as high as 75% in those with non-surgical healing indicating that increased attention to pressure relief is critical for these individuals.This study will evaluate the efficacy of a wheelchair sensor and app-based biofeedback for establishing healthy self-management behaviors (pressure relief maneuvers and daily physical activity). Investigators will enroll 50 participants with paraplegia from spinal cord injury who use a manual wheelchair for mobility and have a history of pressure ulcer that has healed or is six months post-surgical repair. Participants will be randomized into one of two groups: an intervention group that will receive an education intervention and the proposed technology to be used for one year, and a control group that will receive only the education intervention. The primary outcome will be pressure ulcer occurrence over one year. Investigators hypothesize that participants receiving the intervention of biofeedback on their pressure relief activity will have a lower recurrence of pressure ulcer than the education only control group. Secondary outcomes include depressive symptoms, self-efficacy, participation and satisfaction with life. Investigators hypothesize that increasing physical activity will reduce depressive symptoms and improve participation and satisfaction with life.

Conditions

Spinal Cord Injuries; Paraplegia; Pressure Ulcer, Buttock

Keywords

Spinal cord injury; Pressure Ulcer

Outcome Measures

Primary Outcomes (4)

• Recurrence of Pressure Ulcer

  Any stage of Pressure Ulcer/Injury identified in the ischial region

  Any time during the one year active phase of the study intervention

• Change in mean number of cycles of self-propulsion per day from Baseline

  The increase or decrease in number of cycles of self-propulsion per day over the 4 weeks preceding the 12 month assessment

  The four weeks preceding the 12 month assessments

• Change in mean number of pressure relief maneuvers per day from Baseline

  The increase or decrease in mean number of pressure relief maneuvers per day over the 4 weeks preceding the 12 month assessment from Baseline

  The four weeks preceding the 12 month assessments

• Time to Recurrence of Pressure Ulcer

  The number of days from study entry to identification of recurrence of Pressure Ulcer/Injury

  Any time during the one year active phase of the study intervention

Secondary Outcomes (4)

• Change in Patient Health Questionnaire-9 score

  12 months

• Change in University of Washington Self Efficacy Short Form

  12 months

• Change in Reintegration to Normal Living Index

  12 months

• Change in Satisfaction with Life Scale

  12 months

Study Arms (2)

An interactive telehealth monitoring and biofeedback system

EXPERIMENTAL

Participants in this group will receive feedback of pressure relief maneuvers and wheelchair propulsion activity. Feedback for pressure relief will include information during the activity to identify adequate duration and magnitude of pressure relief activity, reminders of when the next pressure relief is due, and daily aggregate information regarding the number of successful pressure relief maneuvers performed.

Device: An interactive telehealth monitoring and biofeedback system

Education Control

SHAM COMPARATOR

Participants will receive education on the importance and recommended frequency of pressure relief maneuver for prevention of pressure ulcer/injury and on the importance and recommended amounts of physical activity for health.

Behavioral: Education Control

Interventions

An interactive telehealth monitoring and biofeedback system DEVICE

A pressure sensitive mat located under the user's wheelchair seat cushion and a wheelchair propulsion monitoring device attached to the chair which are interfaced with a phone App based user interface to provide feed back to promote physical activity and pressure relief maneuver performance among wheelchair users.

An interactive telehealth monitoring and biofeedback system

Education Control BEHAVIORAL

Participants will receive education on importance of pressure relief maneuvers and physical activity and the recommended amounts of each for prevention of pressure ulcer/injury and for physical health.

Education Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• paraplegia from Spinal Cord Injury
• a history of pressure ulcer that has healed or 6 months post surgical repair
• use a manual wheelchair for mobility
• able to perform pressure relief maneuvers independently

You may not qualify if:

• unable/unwilling to return to clinic for follow-up visits

Sponsors & Collaborators

• Rancho Research Institute, Inc.: lead
• BioSensics: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Rancho Los Amigos National Rehabilitaiton Center

Downey, California, 90242, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Pressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sara Mulroy, PhD, PT

  Rancho Los Amigos National Rehab Ce

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Mulroy, PhD, PT

CONTACT

562-385-7177; smulroy@dhs.lacounty.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessors for both skin integrity and psychosocial measures will be blinded to participants' group allocation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: Randomized trial with one intervention arm and one control arm.

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 12, 2020
• Study Start: March 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: January 1, 2022
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)