Comparing Methods for Tracking Health Information at Home After Lung Transplant

NCT ID: NCT00818025

Last Updated: 2023-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-01-31

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.

Conditions

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Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Pocket PATH (Personal Assistant for Tracking Health)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Annette DeVito Dabbs, PhD, RN

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annette DeVito Dabbs, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23867222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21749259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21878796 (View on PubMed)

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.

Reference Type RESULT
PMID: 26729617 (View on PubMed)

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.

Reference Type RESULT
PMID: 27664940 (View on PubMed)

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.

Reference Type RESULT
PMID: 23004565 (View on PubMed)

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.

Reference Type RESULT
PMID: 26308782 (View on PubMed)

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.

Reference Type RESULT
PMID: 27136251 (View on PubMed)

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.

Reference Type RESULT
PMID: 27573324 (View on PubMed)

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.

Reference Type RESULT
PMID: 27437052 (View on PubMed)

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.

Reference Type RESULT
PMID: 27676226 (View on PubMed)

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.

Reference Type RESULT
PMID: 28609813 (View on PubMed)

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.

Reference Type RESULT
PMID: 28517112 (View on PubMed)

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.

Reference Type RESULT
PMID: 31335759 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36094829 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/26729617

PubMed ID: 26729617 (Abstract)

https://pubmed.ncbi.nlm.nih.gov/27664940/

PubMEd ID: 27664940 (Abstract)

https://pubmed.ncbi.nlm.nih.gov/23004565/

PubMed ID: 23004565 (Abstract)

http://pubmed.ncbi.nlm.nih.gov/23867222

PubMed ID: 23867222 (Abstract)

http://pubmed.ncbi.nlm.nih.gov/26308782

PubMed ID: 26308782 (Abstract)

http://pubmed.ncbi.nlm.nih.gov/27136251

PubMed ID: 27136251 (Abstract)

https://pubmed.ncbi.nlm.nih.gov/27573324

Pub Med ID: 27573324 (Abstract)

http://pubmed.ncbi.nlm.nih.gov/27437052

PubMed ID: 27437052 (Abstract)

http://pubmed.ncbi.nlm.nih.gov/27676226

PubMed ID: 27676226 (Abstract)

http://pubmed.ncbi.nlm.nih.gov/28609813

PubMed ID: 28609813 (Abstract)

http://pubmed.ncbi.nlm.nih.gov/28517112

PubMed ID: 28517112 (Abstract)

http://pubmed.ncbi.nlm.nih.gov/31335759

PubMed ID: 31335759 (Abstract)

http://pubmed.ncbi.nlm.nih.gov/21749259

PubMed ID: 21749259 (Abstract)

Other Identifiers

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1R01NR010711-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO08070401

Identifier Type: -

Identifier Source: org_study_id

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