Get Ready And Empowered About Treatment

NCT02165735 | Completed Results

• 1 other identifier: AD-1306-03104
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• Change in Patient Activation Measure (PAM)

  Our primary outcome measure is patient empowerment based on changes in the Patient Activation Measure or PAM. The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. People who score high on the PAM normally understand the importance of taking an active role in managing their health and have the skills and confidence to do so.The scores for the 13-item measure range in value from 0-100, with higher scores indicating greater activation. LEVEL 1 (0-47): May not yet believe that the patient role is important LEVEL 2 (47.1 - 55.1): Lacks confidence and knowledge to take action LEVEL 3 (55.2 - 67.0): Beginning to take action LEVEL 4 (67.1 - 100): Adapting new behaviors, but may have difficulty maintaining over time

  Baseline and 1 year

Secondary Outcomes (10)

• Change in eHealth Literacy Scale (eHEALS)

  Baseline and 1 year

• Change in Decisional Self-Efficacy Scale (DSES)

  Baseline and 1 year

• Change in Perceived Involvement in Care Scale (PICS)

  Baseline and 1 year

• Change in Instrument on Doctor Patient Communication Skills (IDPCS)

  Baseline and 1 year

• Change in HIV Adherence Self-Efficacy Scale (ASES)

  Baseline and 1 year

Study Arms (2)

patient activation training

EXPERIMENTAL

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.

Behavioral: patient activation training

Usual Care

EXPERIMENTAL

Usual care for HIV

Other: Usual care

Interventions

patient activation training 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.

patient activation training

Usual care OTHER

Usual HIV care

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Clinical Directors Network

New York, New York, 10018, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

• 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.

  PMID: 31240605 DERIVED

• 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.

  PMID: 26474979 DERIVED

Results Point of Contact

• Title: Dr. Kevin Fiscella, PI
• Organization: University of Rochester

kevin_fiscella@urmc.rochester.edu

5853244563

Study Officials

• Kevin A Fiscella, MD MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Jonathan Tobin, PhD

  Clinical Directors Network CDN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: August 20, 2014
• Primary Completion: November 30, 2016
• Study Completion: February 28, 2017
• Last Updated: March 15, 2019
• Results First Posted: October 9, 2018

Record last verified: 2019-02

Locations

US (2)