Comparing Methods for Tracking Health Information at Home After Lung Transplant

Study Overview
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Brief Summary
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The purpose of this randomized controlled trial is to test the efficacy of a novel intervention, Pocket PATH (Personal Assistant for Tracking Health) for promoting self-care agency, self-care behaviors, and transplant-related health.

Detailed Description
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Lung transplant recipients (LTR) experience more transplant-related complications, higher health resource utilization, and higher mortality than recipients of other solid organs. Prevention and detection of early complications is known to reduce the likelihood of future impairments in lung function and, therefore, morbidity and mortality. Despite the scarce donor organs and financial resources expended to support individuals throughout the lung transplant experience, no randomized controlled trials (RCT) have tested interventions designed to promote self-care behaviors with the aim of improving transplant-related health after lung transplant. The purpose of this RCT is to compare the efficacy of a novel behavioral intervention, Pocket PATH (Personal Assistant for Tracking Health) for promoting self-care and improving health outcomes relative to standard care after lung transplantation. Pocket PATH provides LTR a hand-held device with customized data recording, trending, and decision-support programs to promote their self-care behaviors. Based on the promising results from our early trials, a full-scale RCT has been designed to rigorously test the efficacy of Pocket PATH in promoting self-care agency, self-care behaviors, and hence improving transplant-related health. A sample of 214 LTR who survive the immediate intensive care unit recovery period will be randomly assigned to either the intervention group, who will be instructed to use the Pocket Path device and its programs designed for self-monitoring, adhering to the regimen, and communicating condition changes to the transplant team, or the control group who will receive standard instructions regarding the post-transplant regimen (including health monitoring). Information will be collected from participants at baseline and 1 week, 2, 6, and 12 months after discharge from the hospital following lung transplantation. Longitudinal, repeated-measures models with planned comparisons will be used to test the hypotheses for the primary aims. It is hypothesized that subjects in the Pocket PATH group will develop higher levels of self-care agency and perform self-care behaviors more often than subjects in the control group and, therefore, will experience fewer transplant-related complications, re-hospitalizations, and better health related quality of life.

Official Title
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Phase III Trial of Pocket PATH: A Computerized Intervention to Promote Self-Care

Conditions
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Lung Disease

Intervention / Treatment
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* Behavioral: Pocket PATH (Personal Assistant for Tracking Health)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a recipient of a lung transplant 18 years of age or older stable enough to be transferred from the CTICU to the acute unit not been discharged from initial transplant hospitalization able to read and speak English Exclusion Criteria: a recipient of any prior transplant a condition that precludes discharge from the hospital limited involvement in post-transplant care is anticipated (e.g., plan to discharge to skilled nursing facility)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>All subjects will receive standard care to prepare for discharge that consists of a one-on-one, pre-discharge educational session delivered by the transplant coordinator prior to hospital discharge and provision of a reference binder for each lung transplant recipient to take home. | |
| Experimental: Pocket PATH hand-held device<br>Participants in the intervention group will be trained to use a hand-held device with custom programs as a means of supporting, tracking, and interpreting discharge activities in addition to the standard paper-tracking methods. | Behavioral: Pocket PATH (Personal Assistant for Tracking Health)<br>* Participants in the intervention group will be trained to use a hand-held device with custom programs as a means of supporting, tracking, and interpreting discharge activities in addition to the standard paper-tracking methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-care agency and self-care behaviors (performing of self-monitoring, adhering to the medical regimen, communicating with the transplant team) |  | 1 year post-discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant-related health |  | 1 year post-discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transplantation, Self-care agency, Self-care behaviors, Hand-held device