Lung Transplant; ComplicationsPERSPIRENCT03792698
Preventing Rehospitalization in Lung Transplant Recipients Utilizing mHealth
A study testing Aidcube digital app-based platform in people with Lung Transplant; Complications, run by University of Pennsylvania at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Lung Transplant; Complications
- What is being tested?
- Aidcube digital app-based platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lung transplant recipient
- SPPB score less than or equal to 9 OR a readmission within 30 days of lung transplant discharge
Who cannot join
- SPPB >9
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Preventing Rehospitalization in Lung Transplant Recipients Through mHealth Utilizing Individualized Rehabilitation Prescriptions
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.
Read the detailed description
Mission and Specific Aims: 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 HRQL, and increased longer-term mortality.
Reflecting these trends, lung transplant recipients have the highest risk of unexpected readmission after the index admission among solid organ transplant patients, with published rates of 38-43%. Over the course of the first post-transplant year, the investigators have shown that 60% of lung transplant recipients have a readmission within 30 days of a hospital discharge, of which 30% occur after initial discharge (as above) and 70% occur after a subsequent readmission (2). Each readmission increases the risk for another unplanned rehospitalization as well as long-term mortality, suggesting that this is a particularly vulnerable population.
Over the last year, the investigators performed a single center cohort study to identify risk factors for readmission after index lung transplant discharge. As part of this initiative, the investigators have been evaluating the role of frailty as measured by the Short Physical Performance Battery (SPPB) test. The SPPB is a three-component battery of lower extremity performance, measures that includes gait speed, chair stands, and balance. The investigators have previously demonstrated that frailty is a risk factor for delisting and death among wait listed lung transplant recipients as well as a significant predictor of mortality within the first year after transplant (Figure 1)(3). In a recent single center cohort study of 90 Penn lung transplant recipients, the investigators demonstrated that patients who are frail at index hospitalization discharge based on SPPB are 3.4 times more likely to have an unplanned re-hospitalization within the next 30 days, regardless of whether they are discharged home or to acute rehab. Interestingly, patients are not frail at the time of listing for transplant - frailty develops during the hospital stay for lung transplantation suggesting that physical frailty is dynamic over a short period of time and may be amenable to intervention. The frequent re-admissions, in part due to significant frailty, lead to 1) increased healthcare expenditures (the median professional and hospital payments at Penn for an unplanned hospitalization following discharge was $13048, 2) severely impact the patient's quality of life, and 3) lead to increased mortality.
The investigators have previously found that, among recipients who were frail at discharge and who were enrolled in an intensive outpatient physical therapy program, the median improvement in SPPB was 6 points and 85.7% became not frail (unpublished data). Although this demonstrates that frailty can be reversed in the lung transplant population, the impact of reduced frailty on subsequent readmission has not been evaluated. It remains unknown whether there are other, less resource intensive, mechanisms for improving frailty. The investigator's belief is that improving access to individualize exercise training plans that are modified based on a patient's progress and needs will greatly improve 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. This study, therefore, targets a population of lung transplant recipients at highest risk for readmission and further complications.
Specific Aim: Evaluate the impact of targeted physical therapy rehabilitation plans utilizing a customizable app based interface on the subsequent readmission rates of lung transplant patients at the highest rate of readmission. Patients who are 1) frail at the time of discharge (SPPB≤8) or 2) have already been readmitted after their transplant hospitalization are at the highest risk of subsequent readmission. The investigators hypothesize that targeted, individualized rehabilitation plans will reduce the risk of subsequent readmission.
- Conditions
- Lung Transplant; Complications
- Being tested
- Aidcube digital app-based platform
- Keywords
- Lung Transplantation, Frailty, Readmisson, Physical Therapy, Personalized
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aidcube digital app-based platformOther
Use of customizable, patient-specific mHealth home rehabilitation plan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Aidcube digital app-based platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (2)
Improved frailty score
Change in short physical performance battery (SPPB) scores
Measured: one year
Health related quality of life
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start15 Jan 2019
- Primary completion31 Jan 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post intervention study design
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Joshua M. Diamond MD,MSCE, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792698
- Sponsor's protocol ID
- 831322
- Acronym
- PERSPIRE
- Status last verified
- Jun 2020
- First submitted
- 14 Dec 2018
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Rehospitalization in Lung Transplant Recipients Through mHealth Utilizing Individualized Rehabilitation Prescriptions
- ClinicalTrials.gov ID
- NCT03792698
- Acronym / sponsor ID
- PERSPIRE / 831322
- Conditions
- Lung Transplant; Complications
- Keywords
- Lung Transplantation, Frailty, Readmisson, Physical Therapy, Personalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mission and Specific Aims: 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 HRQL, and increased longer-term mortality.
Reflecting these trends, lung transplant recipients have the highest risk of unexpected readmission after the index admission among solid organ transplant patients, with published rates of 38-43%. Over the course of the first post-transplant year, the investigators have shown that 60% of lung transplant recipients have a readmission within 30 days of a hospital discharge, of which 30% occur after initial discharge (as above) and 70% occur after a subsequent readmission (2). Each readmission increases the risk for another unplanned rehospitalization as well as long-term mortality, suggesting that this is a particularly vulnerable population.
Over the last year, the investigators performed a single center cohort study to identify risk factors for readmission after index lung transplant discharge. As part of this initiative, the investigators have been evaluating the role of frailty as measured by the Short Physical Performance Battery (SPPB) test. The SPPB is a three-component battery of lower extremity performance, measures that includes gait speed, chair stands, and balance. The investigators have previously demonstrated that frailty is a risk factor for delisting and death among wait listed lung transplant recipients as well as a significant predictor of mortality within the first year after transplant (Figure 1)(3). In a recent single center cohort study of 90 Penn lung transplant recipients, the investigators demonstrated that patients who are frail at index hospitalization discharge based on SPPB are 3.4 times more likely to have an unplanned re-hospitalization within the next 30 days, regardless of whether they are discharged home or to acute rehab. Interestingly, patients are not frail at the time of listing for transplant - frailty develops during the hospital stay for lung transplantation suggesting that physical frailty is dynamic over a short period of time and may be amenable to intervention. The frequent re-admissions, in part due to significant frailty, lead to 1) increased healthcare expenditures (the median professional and hospital payments at Penn for an unplanned hospitalization following discharge was $13048, 2) severely impact the patient's quality of life, and 3) lead to increased mortality.
The investigators have previously found that, among recipients who were frail at discharge and who were enrolled in an intensive outpatient physical therapy program, the median improvement in SPPB was 6 points and 85.7% became not frail (unpublished data). Although this demonstrates that frailty can be reversed in the lung transplant population, the impact of reduced frailty on subsequent readmission has not been evaluated. It remains unknown whether there are other, less resource intensive, mechanisms for improving frailty. The investigator's belief is that improving access to individualize exercise training plans that are modified based on a patient's progress and needs will greatly improve 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. This study, therefore, targets a population of lung transplant recipients at highest risk for readmission and further complications.
Specific Aim: Evaluate the impact of targeted physical therapy rehabilitation plans utilizing a customizable app based interface on the subsequent readmission rates of lung transplant patients at the highest rate of readmission. Patients who are 1) frail at the time of discharge (SPPB≤8) or 2) have already been readmitted after their transplant hospitalization are at the highest risk of subsequent readmission. The investigators hypothesize that targeted, individualized rehabilitation plans will reduce the risk of subsequent readmission.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post intervention study design
| Arm | Type | Receives |
|---|---|---|
| Aidcube utilization | Experimental | Other: Aidcube digital app-based platformAidcube 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. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lung transplant recipient
- SPPB score less than or equal to 9 OR a readmission within 30 days of lung transplant discharge
Key exclusion criteria (1 listed)
- SPPB >9
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aidcube digital app-based platformUse of customizable, patient-specific mHealth home rehabilitation plan | Other | Aidcube utilization |
Primary outcome
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
2 secondary outcomes
Improved frailty score
Time frame: one year
Health related quality of life
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aidcube digital app-based platform in people with Lung Transplant; Complications, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.