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Interactive Telehealth for Wheelchair Users

10 febbraio 2020 aggiornato da: Sara Mulroy, Rancho Research Institute, Inc.

Interactive Telehealth and Auto-Biofeedback Sensor System for Individuals Who Use a Wheelchair: Phase II

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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Purpose: The purpose of this study is to evaluate the efficacy of an interactive tele-health monitoring and biofeedback system to establish healthy behaviors and promote self-management of pressure relief maneuvers and physical activity.

Procedures and Course of Study:

Baseline 50 participants will be enrolled. At study entry participants will complete four baseline questionnaires and have a Nurse Practitioner or Physician's Assistant inspect their ischial skin to ensure that their prior ulcer is fully healed. A pressure-sensing mat (PRESS) will be placed under their wheelchair cushion, and a wheelchair propulsion motion sensor (WAMS) will be placed on the rear wheel of their wheelchair. The PRESS and WAMS sensors will record participants' pressure relief and wheelchair propulsion activity for the next two weeks.

Intervention:

Participants will then return to the clinic and the study physical therapist will provide all participants with education on importance of pressure relief maneuvers and physical activity for health as well as training in the 3 styles of pressure relief (forward and side leans, depression raise) and shoulder strengthening exercises to protect against shoulder impingement and pain with increased pressure relief and wheelchair propulsion activity. The study physical therapist will then assist all participants in setting goals to increase pressure relief frequency and/or duration and wheelchair propulsion pushes for the future based on their baseline activity. Participants will be randomized into one of two groups: feedback and no feedback. In both groups pressure relief and wheelchair propulsion activity will be recorded by the PRESS and WAMS sensors for the 12 months. Those participants in the no-feedback group will have the feedback features of the system disabled. Those participants in the feedback group will receive instant visual feedback on pressure relief duration and daily summary charts for both pressure relief and wheelchair propulsion activities.

Follow-up:

Every month following the intervention for 12 months, a physical therapist will contact participants by phone to inquire whether their ischial skin integrity has changed and whether they have developed a pressure ulcer. Additionally, all participants will return to the clinic at 3, 6, 9, and 12 months after the intervention and a nurse practitioner will examine their ischial skin and review their medical records to determine if a pressure ulcer has developed. Participants will repeat the 4 questionnaires from the baseline evaluation at each follow-up visit. At the 12 month follow-up visit, participants will return the sensor equipment.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • Downey, California, Stati Uniti, 90242
        • Rancho Los Amigos National Rehabilitaiton Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: An interactive telehealth monitoring and biofeedback system
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.
Dispositivo: An interactive telehealth monitoring and biofeedback system
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.
Comparatore fittizio: Education Control
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.
Comportamentale: Education Control
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recurrence of Pressure Ulcer
Lasso di tempo: Any time during the one year active phase of the study intervention
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
Lasso di tempo: The four weeks preceding the 12 month assessments
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
Lasso di tempo: The four weeks preceding the 12 month assessments
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
Lasso di tempo: Any time during the one year active phase of the study intervention
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Patient Health Questionnaire-9 score
Lasso di tempo: 12 months
Change in Questionnaire scores measuring depressive symptoms at 12 month assessment from baseline score
12 months
Change in University of Washington Self Efficacy Short Form
Lasso di tempo: 12 months
Change in scores on Questionnaire measuring self-efficacy at 12 month assessment from baseline score
12 months
Change in Reintegration to Normal Living Index
Lasso di tempo: 12 months
Change score on Questionnaire measuring participation at 12 month assessment from baseline score
12 months
Change in Satisfaction with Life Scale
Lasso di tempo: 12 months
Change in score on Questionnaire measuring satisfaction with life at 12 month assessment from baseline score
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Rancho Research Institute, Inc.

Collaboratori

National Institute on Aging (NIA)
BioSensics

Investigatori

  • Investigatore principale: Sara Mulroy, PhD, PT, Rancho Los Amigos National Rehab Ce

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 marzo 2020

Completamento primario (Anticipato)

1 aprile 2021

Completamento dello studio (Anticipato)

1 gennaio 2022

Date di iscrizione allo studio

Primo inviato

7 febbraio 2020

Primo inviato che soddisfa i criteri di controllo qualità

10 febbraio 2020

Primo Inserito (Effettivo)

12 febbraio 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 febbraio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 febbraio 2020

Ultimo verificato

1 febbraio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 5R44AG059275-04 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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