Comparing Methods for Tracking Health Information at Home After Lung Transplant

October 2, 2023 updated by: Annette DeVito Dabbs, PhD, RN, University of Pittsburgh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
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
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)
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Annette DeVito Dabbs, PhD, RN, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 6, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimated)

January 7, 2009

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO08070401
  • 1R01NR010711-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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