Comparing Methods for Tracking Health Information at Home After Lung Transplant

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00818025
First received: January 6, 2009
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Lung Transplantation
Behavioral: Pocket PATH (Personal Assistant for Tracking Health)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase III Trial of Pocket PATH: A Computerized Intervention to Promote Self-Care

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transplant-related health [ Time Frame: 1 year post-discharge ] [ Designated as safety issue: No ]

Enrollment: 211
Study Start Date: January 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818025

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Annette DeVito Dabbs, PhD, RN University of Pittsburgh
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00818025     History of Changes
Other Study ID Numbers: PRO08070401, 1R01NR010711-01
Study First Received: January 6, 2009
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Lung transplantation
Self-care agency
Self-care behaviors
Hand-held device

ClinicalTrials.gov processed this record on April 17, 2014