Lung Disease Clinical Trial
Official title:
Phase III Trial of Pocket PATH: A Computerized Intervention to Promote Self-Care
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT02253667 -
Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients
|
N/A | |
| Completed |
NCT02217423 -
Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy
|
N/A | |
| Completed |
NCT01679301 -
Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator
|
N/A | |
| Completed |
NCT02345135 -
Susceptibility to Infections in Ataxia Telangiectasia
|
N/A | |
| Terminated |
NCT00966823 -
Fetal Tracheal Balloon Study in Diaphragmatic Hernia
|
Phase 2 | |
| Completed |
NCT00139152 -
Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair
|
Phase 4 | |
| Completed |
NCT00052052 -
An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF)
|
Phase 2 | |
| Completed |
NCT00013949 -
Cardiovascular Vulnerability to Particulate Exposure
|
N/A | |
| Recruiting |
NCT02963467 -
Effect of Smoking on Ventilation-Perfusion Ratio
|
N/A | |
| Recruiting |
NCT02965300 -
The Value of VOCs Analysis in Exhaled Breath for Pulmonary Benign and Malignant Lesion Diagnosis
|
N/A | |
| Enrolling by invitation |
NCT02946658 -
Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02913365 -
Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis
|
N/A | |
| Completed |
NCT01735526 -
Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide After Hematopoietic Stem-cell Transplantation
|
N/A | |
| Completed |
NCT01952002 -
Clinical Safety for the Inspiratory Muscle Training
|
N/A | |
| Recruiting |
NCT01450644 -
Evaluation of the Hospital2Home Palliative Care Service for Patients With Advanced Progressive Lung Disease
|
Phase 2 | |
| Completed |
NCT01215279 -
AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)
|
Phase 2 | |
| Completed |
NCT01153321 -
Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
| Completed |
NCT00837681 -
Pulmonary Complications of Hematopoietic Stem Cell Transplantation
|
N/A | |
| Completed |
NCT02055222 -
Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease
|
||
| Completed |
NCT01222442 -
To Evaluate the Effect of AZD3199 on the Electrical Activity in the Heart
|
Phase 1 |