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NCT01739803 · ClinicalTrials.gov registry record · NA

Behavioral Contract Adherence Intervention

A NA study, sponsored by University of Tennessee.

Completed
Registry status
NA
Development phase
150
Enrollment target

NCT01739803 is a NA study that has completed, run by University of Tennessee. The registered enrollment target is 150 participants.

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The verdict

NCT01739803, a NA study, has completed, sponsored by University of Tennessee.

COMPLETED
Registry status
NA
Development phase
150 participants
Enrollment target

Study Summary

There is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and clinical outcomes. The objectives of this project were to address this gap through: (1) designing, implementing, and evaluating a patient-specific behavioral contract intervention to improve RTRs' IST adherence rates (contracts are written, signed agreements between the RTR and healthcare provider in which the RTR agrees to be adherent to IST according to mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs' health-related quality of life (HQoL) and healthcare utilizations and costs. The primary hypothesis was that at one year post trial enrollment, RTRs who establish behavioral contracts with healthcare professionals will be more adherent than those who do not establish behavioral contracts and subsequently will have greater HQoL and lower healthcare utilizations and costs. Once it is better understood how to implement effective IST adherence intervention programs, clinicians will have a valuable tool to promote therapeutic success, improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued the following Specific Aims: (1) determine the effectiveness of an IST adherence contract-based intervention on IST adherence; (2) determine the relationship between IST adherence, the intervention, and RTRs' HQoL; and (3) determine the influence of IST adherence and the intervention on RTRs' healthcare utilizations/costs. To achieve the Specific Aims, a randomized controlled trial of the patient-specific behavioral contract-based intervention was conducted, and data regarding adherence, HQoL, and healthcare utilizations/costs were collected over a 12-month period for each RTR study participant and analyzed. This project will promote healthy lives, increase well-being, and reduce burden of illness and disparity among adult RTRs by providing data

Interventions

  • BEHAVIORAL Behavioral Contract

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2010-01
Est. Completion 2013-06
Phase NA

Sponsor

University of Tennessee

96 total trials

What the Registry Record Tells You About NCT01739803

The ClinicalTrials.gov registry entry for NCT01739803 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Tennessee, which has 96 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Behavioral Contract is the first listed.

NCT01739803 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01739803 about?

NCT01739803 is a clinical study titled "Behavioral Contract Adherence Intervention". There is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and clinical outcomes. The objectives of this project were to address this gap through: (1) designing, implementing, and ev...

What is the current status of trial NCT01739803?

This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2010-01. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01739803?

The interventions under investigation include: Behavioral Contract (BEHAVIORAL).

Who is sponsoring clinical trial NCT01739803?

This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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