Preventing Rehospitalization in Lung Transplant Recipients Utilizing mHealth

NCT03792698 | Completed

• 1 other identifier: 831322
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Transplant; Complications

Keywords

Lung Transplantation; Frailty; Readmisson; Physical Therapy; Personalized

Outcome Measures

Primary Outcomes (1)

• Readmission

  difference in readmission rate over the year prior to the above described intervention with the readmission rate in the setting of Aidcube app utilization

  one year

Secondary Outcomes (2)

• Improved frailty score

  one year

• Health related quality of life

  one year

Study Arms (1)

Aidcube utilization

EXPERIMENTAL

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

Interventions

Aidcube digital app-based platform OTHER

Use of customizable, patient-specific mHealth home rehabilitation plan

Aidcube utilization

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• SPPB \>9

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of California, San Francisco: collaborator

Study Sites (2)

University of California San Francisco

San Francisco, California, 94143, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Pre-post intervention study design

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: January 3, 2019
• Study Start: January 15, 2019
• Primary Completion: January 31, 2020
• Study Completion: June 1, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)