Interactive Telehealth for Pressure Ulcer Prevention After SCI

NCT03469141 | Unknown FDA Device

• 1 other identifier: 90SI5018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this module project is to establish the efficacy of a portable sensor and app-based biofeedback technology system for promoting effective pressure relief behaviors and reducing risk of pressure ulcer development among wheelchair users. In collaboration with the participating SCIMS centers, the investigators will conduct a randomized clinical trial of education and goal setting alone compared to education and goal setting combined with the biofeedback system (SENSIMAT®) that is commercially available.

Conditions

Spinal Cord Injuries; Pressure Ulcer

Keywords

Wheelchair; Pressure Relief; Activity; Monitor

Outcome Measures

Primary Outcomes (2)

• PR maneuvers per day

  Number of pressure relief maneuvers per day

  8 weeks

• Sitting time

  Duration of uninterrupted sitting time in minutes per day

  8 weeks

Secondary Outcomes (1)

• Pressure Ulcer Occurence

  1 year

Study Arms (2)

Control Group

NO INTERVENTION

The control group will continue to have the WC sensor system for measurement only and will not receive biofeedback after receiving instructions on the importance of pressure relief (PR) maneuvers for skin care, as well as training regarding the three pressure relief maneuvers. Materials (including fact sheets, etc.) will be incorporated in the educational content of the project.

Intervention Group

EXPERIMENTAL

The intervention group will receive biofeedback via the smartphone app.

Device: Pressure Relief Monitoring System

Interventions

Pressure Relief Monitoring System DEVICE

Biofeedback provided to the intervention group via the smartphone app will include: Visual (e.g., phone notification bar) and auditory reminders if PR (pressure relief) is not performed as scheduled, Real-time feedback during performance of PR maneuvers to ensure adequate PR (e.g., the app will indicate if the duration of PR is sufficient), and Aggregate counts of daily PR activity.

Also known as: Sensimat

Intervention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with documented SCI, American Spinal Injury Association Impairment Scale (AIS) A, B, or C.
• Persons who are full time manual wheelchair users.
• persons over the age of 18.
• months post-injury.
• Able to perform pressure relief maneuvers without assistance
• Cognitively able to understand and sign informed consent form approved by the IRB
• Free of shoulder pain that interferes with daily activities or requires medical intervention at the time of enrollment in the study

You may not qualify if:

• History of shoulder injury or surgery or orthopedic or neurologic disorders (other than SCI) that would impact arm function, preventing them from performing pressure ulcer relief maneuvers or propelling a wheelchair.
• history of ischial pressure ulcer.

Sponsors & Collaborators

• Rancho Research Institute, Inc.: lead

Study Sites (4)

University of Alabama

Birmingham, Alabama, 35249, United States

RECRUITING

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19102, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Pressure Ulcer; Motor Activity

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Sara J Mulroy, PhD,PT

  Rancho Los Amigos National Rehabilitation Center

  STUDY DIRECTOR

Central Study Contacts

Valerie Eberly, PT

CONTACT

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

Philip S Requejo, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Following the training/goal setting session, participants will be randomly assigned into either the intervention group that will receive biofeedback via the smartphone app for 4 weeks, or the control group that will continue to have the WC sensor system for measurement only and will not receive biofeedback.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director

Model Details: All participants will complete two weeks of recording PR behavior by the monitoring system without feedback. Following baseline assessment, participants will be randomized into one of two groups: an intervention group that will receive an education session on PU prevention with goal setting for PR frequency and duration followed by four weeks of biofeedback via the smartphone app component of the monitoring system, or a control group that will receive only the education and goal setting session, but will not receive biofeedback and will have the WC sensor system for measurement only. After four weeks, the biofeedback feature in the intervention group will be turned off. The system will continue to monitor activities for another two weeks. We will assess whether improvements in PR adherence are retained after the 4-week bout of biofeedback (washout). Participants will return one year following the 8-week intervention to assess whether they have developed a PU.

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: May 1, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2021
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

US (4)