Get Ready And Empowered About Treatment

NCT ID: NCT02165735

Last Updated: 2019-03-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-20

Study Completion Date

2017-02-28

Brief Summary

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The purpose of this study is to rigorously assess a program designed to empower patient living with HIV, to improve their health care and health, and to reduce disparities.

Detailed Description

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Our project has four major aims:

1. Assess improvement in patient empowerment
2. Assess improvement in patients' receipt of evidence-based care
3. Assess improvement in patients' health
4. Assess reduction in disparities in empowerment

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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patient activation training

Patient activation training involves six, 90-minute, group (8-12 person) training sessions facilitated by trained peers and training staff and one (20-30 minute) pre-visit coaching session conducted by staff. The hands on group training includes: 1) HIV education; 2) use of a handheld smart device; 3) use of an HIV electronic personal health record app that runs on the smart device; 4) identification of patients' visit need priorities and skills for communicating with their HIV provider. The pre-visit coaching includes identification patient concerns and patient behavioral rehearsal for asking about these concerns.

Group Type EXPERIMENTAL

patient activation training

Intervention Type BEHAVIORAL

Patient activation training involves six, 90-minute, group (8-12 person) training sessions facilitated by trained peers and training staff and one (20-30 minute) pre-visit coaching session conducted by staff. The hands on group training includes: 1) HIV education; 2) use of a handheld smart device; 3) use of an HIV electronic personal health record app that runs on the smart device; 4) identification of patients' visit need priorities and skills for communicating with their HIV provider. The pre-visit coaching includes identification of patient concerns and patient behavioral rehearsal for asking about these concerns.

Usual Care

Usual care for HIV

Group Type EXPERIMENTAL

Usual care

Intervention Type OTHER

Usual HIV care

Interventions

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patient activation training

Patient activation training involves six, 90-minute, group (8-12 person) training sessions facilitated by trained peers and training staff and one (20-30 minute) pre-visit coaching session conducted by staff. The hands on group training includes: 1) HIV education; 2) use of a handheld smart device; 3) use of an HIV electronic personal health record app that runs on the smart device; 4) identification of patients' visit need priorities and skills for communicating with their HIV provider. The pre-visit coaching includes identification of patient concerns and patient behavioral rehearsal for asking about these concerns.

Intervention Type BEHAVIORAL

Usual care

Usual HIV care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age18 years or older,
* confirmed HIV diagnosis
* receipt of care within a participating site.

Exclusion Criteria

* inability to provide informed consent
* limited English proficiency (Trainings and Personal Health Record are currently only available in English)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Kevin Fiscella

MD, MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin A Fiscella, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Jonathan Tobin, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Directors Network CDN

Locations

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Clinical Directors Network

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

References

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Carroll JK, Tobin JN, Luque A, Farah S, Sanders M, Cassells A, Fine SM, Cross W, Boyd M, Holder T, Thomas M, Overa CC, Fiscella K. "Get Ready and Empowered About Treatment" (GREAT) Study: a Pragmatic Randomized Controlled Trial of Activation in Persons Living with HIV. J Gen Intern Med. 2019 Sep;34(9):1782-1789. doi: 10.1007/s11606-019-05102-7. Epub 2019 Jun 25.

Reference Type DERIVED
PMID: 31240605 (View on PubMed)

Fiscella K, Boyd M, Brown J, Carroll J, Cassells A, Corales R, Cross W, El'Daher N, Farah S, Fine S, Fowler R, Hann A, Luque A, Rodriquez J, Sanders M, Tobin J. Activation of persons living with HIV for treatment, the great study. BMC Public Health. 2015 Oct 16;15:1056. doi: 10.1186/s12889-015-2382-1.

Reference Type DERIVED
PMID: 26474979 (View on PubMed)

Other Identifiers

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AD-1306-03104

Identifier Type: -

Identifier Source: org_study_id

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