Interactive Telehealth for Pressure Ulcer Prevention After SCI

June 11, 2018 updated by: Sara Mulroy, Rancho Research Institute, Inc.

Interactive Telehealth and Auto-Biofeedback Sensor System for Pressure Ulcer Prevention After SCI

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Overview and Rationale:

Pressure ulcers (PUs) are a frequent and serious secondary complication after SCI with an annual incidence of 31% and a lifetime incidence of up to 85%. PUs are linked to increased morbidity and mortality. As medical or surgical repair of established PUs is difficult and costly, the preferred approach is prevention. Traditional prevention recommendations included intermittent relief of interface pressure, such as performing wheelchair (WC) pushups every 30 minutes for 30 seconds or once an hour for 60 seconds. Alternatives to the push-up maneuver, including forward and lateral trunk leans, have been recommended to reduce the demands of weight bearing on the shoulders. One approach to address inadequate PR is to provide a simple reminder (i.e., an alarm) at set intervals. However, this approach is inadequate because patients who attempt PR maneuvers often do not achieve an adequate magnitude or duration of PR for tissue unloading. In addition, compliance with PR performance can be negatively impacted by unanticipated life circumstances. A system to measure PR maneuvers in the home and community and provide reminders and feedback on frequency and success of individual attempts of this important preventative activity could reduce the incidence of PUs. In this collaborative project, the investigators will establish the efficacy of a sensor and feedback technology system for promoting effective pressure relief behaviors and reducing risk of pressure ulcer development among wheelchair users. 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 (sensor and smartphone app) that is developed and validated. The fully functional system is unobtrusive and simple. The system attaches to any WC (without modification) and generates automatic reminders via an app. Biofeedback, also delivered via the app, indicates in real time when a PR maneuver has been completed successfully. The display also tracks the user's daily PR activity as the participants works towards a daily goal.

Specific Aims:

Primary: Compare PR behavior (daily PR frequency and average duration of uninterrupted sitting) between participants who receive education and four weeks of biofeedback training with the monitoring system (intervention group) and those who receive education but no system feedback (control group). Secondary: Compare the incidence of ischial PU development at one year post-intervention between groups.

Hypotheses:

1) Biofeedback from the monitoring system will increase PR frequency and decrease uninterrupted sitting time compared to that achieved by education and goal setting without feedback. 2) Improvements in PR adherence will be retained after two weeks of wash-out (no feedback). 1) Incidence of ischial PU development will be lower in participants who receive feedback training with the telehealth monitoring system than in the control group. Methods: Participants will be at least 18 years of age, between 2 and 6 months post SCI, full-time WC users for community mobility (AIS A-C), able to perform PR maneuvers without assistance, and have no current or prior history of a PU. A total of one hundred (n=100) manual WC users from all collaborating centers will participate in an 8-week monitoring trial with a one-year follow-up to assess PU development. 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. The investigators 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. Participants will be queried and their medical record reviewed regarding PU occurrence since the intervention. A physician, nurse, or other clinician will examine participants' skin visually and record presence of any PUs (stages 1-4) in the ischial region.

Proposed Outcomes:

To establish the efficacy of the wheelchair seat sensor and app-based biofeedback for establishing healthy self-management behaviors (pressure relief maneuvers) and reducing incidence of pressure ulcer development in individuals with recent SCI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Recruiting
        • University of Alabama
        • Contact:
    • California
      • Downey, California, United States, 90242
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
          • Diana D Cardenas, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Recruiting
        • Thomas Jefferson University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 2-6 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Control Group
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.
EXPERIMENTAL: Intervention Group
The intervention group will receive biofeedback via the smartphone app.
Device: Pressure Relief Monitoring System
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.
Other Names:
  • Sensimat

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PR maneuvers per day
Time Frame: 8 weeks
Number of pressure relief maneuvers per day
8 weeks
Sitting time
Time Frame: 8 weeks
Duration of uninterrupted sitting time in minutes per day
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pressure Ulcer Occurence
Time Frame: 1 year
Incidence of ischial pressure ulcer occurence after one year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rancho Research Institute, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sara J Mulroy, PhD,PT, Rancho Los Amigos National Rehabilitation Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 90SI5018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified primary and secondary outcomes data will be shared with collaborators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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