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Comparing Methods for Tracking Health Information at Home After Lung Transplant

Primary Purpose

Lung Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pocket PATH (Personal Assistant for Tracking Health)
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Disease focused on measuring Transplantation, Self-care agency, Self-care behaviors, Hand-held device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Pocket PATH hand-held device

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Self-care agency and self-care behaviors (performing of self-monitoring, adhering to the medical regimen, communicating with the transplant team)

Secondary Outcome Measures

Transplant-related health

Full Information

First Posted
January 6, 2009
Last Updated
October 2, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00818025
Brief Title
Comparing Methods for Tracking Health Information at Home After Lung Transplant
Official Title
Phase III Trial of Pocket PATH: A Computerized Intervention to Promote Self-Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Disease
Keywords
Transplantation, Self-care agency, Self-care behaviors, Hand-held device

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Pocket PATH hand-held device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pocket PATH (Personal Assistant for Tracking Health)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Transplant-related health
Time Frame
1 year post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette DeVito Dabbs, PhD, RN
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23867222
Citation
DeVito Dabbs A, Song MK, Myers B, Hawkins RP, Aubrecht J, Begey A, Connolly M, Li R, Pilewski JM, Bermudez CA, Dew MA. Clinical trials of health information technology interventions intended for patient use: unique issues and considerations. Clin Trials. 2013;10(6):896-906. doi: 10.1177/1740774513493149. Epub 2013 Jul 18.
Results Reference
background
PubMed Identifier
21749259
Citation
Kovach KA, Aubrecht JA, Dew MA, Myers B, Dabbs AD. Data safety and monitoring for research involving remote health monitoring. Telemed J E Health. 2011 Sep;17(7):574-9. doi: 10.1089/tmj.2010.0219. Epub 2011 Jul 12.
Results Reference
background
PubMed Identifier
21878796
Citation
Devito Dabbs A, Song MK, Hawkins R, Aubrecht J, Kovach K, Terhorst L, Connolly M, McNulty M, Callan J. An intervention fidelity framework for technology-based behavioral interventions. Nurs Res. 2011 Sep-Oct;60(5):340-7. doi: 10.1097/NNR.0b013e31822cc87d.
Results Reference
background
PubMed Identifier
26729617
Citation
DeVito Dabbs A, Song MK, Myers BA, Li R, Hawkins RP, Pilewski JM, Bermudez CA, Aubrecht J, Begey A, Connolly M, Alrawashdeh M, Dew MA. A Randomized Controlled Trial of a Mobile Health Intervention to Promote Self-Management After Lung Transplantation. Am J Transplant. 2016 Jul;16(7):2172-80. doi: 10.1111/ajt.13701. Epub 2016 Mar 14.
Results Reference
result
PubMed Identifier
27664940
Citation
Rosenberger EM, DeVito Dabbs AJ, DiMartini AF, Landsittel DP, Pilewski JM, Dew MA. Long-Term Follow-up of a Randomized Controlled Trial Evaluating a Mobile Health Intervention for Self-Management in Lung Transplant Recipients. Am J Transplant. 2017 May;17(5):1286-1293. doi: 10.1111/ajt.14062. Epub 2016 Oct 31.
Results Reference
result
PubMed Identifier
23004565
Citation
DeVito Dabbs A, Terhorst L, Song MK, Shellmer DA, Aubrecht J, Connolly M, Dew MA. Quality of recipient-caregiver relationship and psychological distress are correlates of self-care agency after lung transplantation. Clin Transplant. 2013 Jan-Feb;27(1):113-20. doi: 10.1111/ctr.12017. Epub 2012 Sep 24.
Results Reference
result
PubMed Identifier
26308782
Citation
Zaldonis J, Alrawashdeh M, Atman KS, Fatigati A, Dabbs AD, Bermudez CA. Predictors and influence of goal orientation on self-management and health-related quality of life after lung transplant. Prog Transplant. 2015 Sep;25(3):230-42. doi: 10.7182/pit2015189.
Results Reference
result
PubMed Identifier
27136251
Citation
Fatigati A, Alrawashdeh M, Zaldonis J, Dabbs AD. Patterns and Predictors of Sleep Quality Within the First Year After Lung Transplantation. Prog Transplant. 2016 Mar;26(1):62-9. doi: 10.1177/1526924816632123.
Results Reference
result
PubMed Identifier
27573324
Citation
Jiang Y, Sereika SM, DeVito Dabbs A, Handler SM, Schlenk EA. Using mobile health technology to deliver decision support for self-monitoring after lung transplantation. Int J Med Inform. 2016 Oct;94:164-71. doi: 10.1016/j.ijmedinf.2016.07.012. Epub 2016 Jul 19.
Results Reference
result
PubMed Identifier
27437052
Citation
Jiang Y, Sereika SM, Dabbs AD, Handler SM, Schlenk EA. Acceptance and Use of Mobile Technology for Health Self-Monitoring in Lung Transplant Recipients during the First Year Post-Transplantation. Appl Clin Inform. 2016 Jun 1;7(2):430-45. doi: 10.4338/ACI-2015-12-RA-0170. eCollection 2016.
Results Reference
result
PubMed Identifier
27676226
Citation
Alrawashdeh M, Zomak R, Dew MA, Sereika S, Song MK, Pilewski JM, DeVito Dabbs A. Pattern and Predictors of Hospital Readmission During the First Year After Lung Transplantation. Am J Transplant. 2017 May;17(5):1325-1333. doi: 10.1111/ajt.14064. Epub 2016 Oct 27.
Results Reference
result
PubMed Identifier
28609813
Citation
Hu L, Lingler JH, DeVito Dabbs A, Dew MA, Sereika SM. Trajectories of self-care agency and associated factors in lung transplant recipients over the first 12 months following transplantation. Clin Transplant. 2017 Sep;31(9):10.1111/ctr.13030. doi: 10.1111/ctr.13030. Epub 2017 Jul 13.
Results Reference
result
PubMed Identifier
28517112
Citation
Hu L, DeVito Dabbs A, Dew MA, Sereika SM, Lingler JH. Patterns and correlates of adherence to self-monitoring in lung transplant recipients during the first 12 months after discharge from transplant. Clin Transplant. 2017 Aug;31(8):10.1111/ctr.13014. doi: 10.1111/ctr.13014. Epub 2017 Jun 11.
Results Reference
result
PubMed Identifier
31335759
Citation
Geramita EM, DeVito Dabbs AJ, DiMartini AF, Pilewski JM, Switzer GE, Posluszny DM, Myaskovsky L, Dew MA. Impact of a Mobile Health Intervention on Long-term Nonadherence After Lung Transplantation: Follow-up After a Randomized Controlled Trial. Transplantation. 2020 Mar;104(3):640-651. doi: 10.1097/TP.0000000000002872.
Results Reference
result
PubMed Identifier
36094829
Citation
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/26729617
Description
PubMed ID: 26729617 (Abstract)
URL
https://pubmed.ncbi.nlm.nih.gov/27664940/
Description
PubMEd ID: 27664940 (Abstract)
URL
https://pubmed.ncbi.nlm.nih.gov/23004565/
Description
PubMed ID: 23004565 (Abstract)
URL
http://pubmed.ncbi.nlm.nih.gov/23867222
Description
PubMed ID: 23867222 (Abstract)
URL
http://pubmed.ncbi.nlm.nih.gov/26308782
Description
PubMed ID: 26308782 (Abstract)
URL
http://pubmed.ncbi.nlm.nih.gov/27136251
Description
PubMed ID: 27136251 (Abstract)
URL
https://pubmed.ncbi.nlm.nih.gov/27573324
Description
Pub Med ID: 27573324 (Abstract)
URL
http://pubmed.ncbi.nlm.nih.gov/27437052
Description
PubMed ID: 27437052 (Abstract)
URL
http://pubmed.ncbi.nlm.nih.gov/27676226
Description
PubMed ID: 27676226 (Abstract)
URL
http://pubmed.ncbi.nlm.nih.gov/28609813
Description
PubMed ID: 28609813 (Abstract)
URL
http://pubmed.ncbi.nlm.nih.gov/28517112
Description
PubMed ID: 28517112 (Abstract)
URL
http://pubmed.ncbi.nlm.nih.gov/31335759
Description
PubMed ID: 31335759 (Abstract)
URL
http://pubmed.ncbi.nlm.nih.gov/21749259
Description
PubMed ID: 21749259 (Abstract)
URL
http://pubmed.ncbi.nlm.nih.gov/21878796
Description
Pub Med ID: 21878796

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Comparing Methods for Tracking Health Information at Home After Lung Transplant

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