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Preventing Rehospitalization in Lung Transplant Recipients Utilizing mHealth (PERSPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03792698
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : February 25, 2019
University of California, San Francisco
Information provided by (Responsible Party):
Joshua M. Diamond MD,MSCE, University of Pennsylvania

Brief Summary:
Lung transplantation has several important aims: 1) extend survival; 2) relieve disability, and 3) improve health-related quality of life (HRQL) for adults suffering from end-stage lung disease. Advances in medical therapies and changes in the US organ allocation system in 2005 have prioritized lung transplant for sicker and older patients. This achievement has come at substantial cost, including recent trends in recipients towards increased disability, poorer health-related quality of life, and increased longer-term mortality. Additionally, lung transplant recipients have the highest risk of unexpected readmission after the index admission, with published rates of 40-43%. Frailty at the time of discharge is one of the leading factors for readmission. The investigator's belief is that improving access to individualized exercise training plans that are modified based on a patient's progress and needs will greatly improve a transplant recipient's level of physical fitness and independence, and decrease the risk of hospital readmission. This will lead to an overall improvement in a patient's quality of life.

Condition or disease Intervention/treatment Phase
Lung Transplant; Complications Other: Aidcube digital app-based platform Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pre-post intervention study design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventing Rehospitalization in Lung Transplant Recipients Through mHealth Utilizing Individualized Rehabilitation Prescriptions
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Aidcube utilization
Aidcube is a fully customizable, commercially available digital "app"-based platform to deliver home-based pulmonary rehabilitation for patients. On the patient-facing side, patients can view their daily exercise prescription, descriptions and videos demonstrating correct execution of the exercises, document completion of exercises, and message their health-care provider. On the provider-facing side, from over 150 available exercises, surveys, and activities, providers can design a fully-customized exercise prescription. Based on real-time patient feedback, the exercise prescription can be progressed (i.e., advanced and/or modified) by adding repetitions or time to specific exercises or adding new activities. The provider can also message the patient from within the Aidcube environment.
Other: Aidcube digital app-based platform
Use of customizable, patient-specific mHealth home rehabilitation plan

Primary Outcome Measures :
  1. Readmission [ Time Frame: one year ]
    difference in readmission rate over the year prior to the above described intervention with the readmission rate in the setting of Aidcube app utilization

Secondary Outcome Measures :
  1. Improved frailty score [ Time Frame: one year ]
    Change in short physical performance battery (SPPB) scores

  2. Health related quality of life [ Time Frame: one year ]
    Change in HRQOL as measured by the Medical Outcomes Survey Short Form 12 (SF12). The SF12 is a 12 question survey designed to assess a subjects mental and physical functioning as well as overall health related quality of life. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm with a mean score of 50.0 and a standard deviation of 10.0. Higher score indicated higher level of functioning.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Lung transplant recipient
  • SPPB score less than or equal to 9 OR a readmission within 30 days of lung transplant discharge

Exclusion Criteria:

  • SPPB >9

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03792698

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United States, California
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Steven Hays, MD   
Contact: Jonathan Singer, MD, MS   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joshua M Diamond, MD, MSCE    215-615-5030   
Sponsors and Collaborators
University of Pennsylvania
University of California, San Francisco

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Responsible Party: Joshua M. Diamond MD,MSCE, Assistant Professor of Medicine, University of Pennsylvania Identifier: NCT03792698     History of Changes
Other Study ID Numbers: 831322
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joshua M. Diamond MD,MSCE, University of Pennsylvania:
Lung Transplantation
Physical Therapy