AzTrials
AzTrials

HIVGREATNCT02165735

Get Ready And Empowered About Treatment

A study testing patient activation training in people with HIV, run by University of Rochester at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
What is being tested?
patient activation training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
2 sitesUnited States
Study dates
20 Aug 2014to 28 Feb 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Clinical Directors Network

    New York, New York, 10018

  • University of Rochester

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: Addressing HIV Tx Disparities Through Patient Empowerment

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.

Read the detailed description

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
HIV
Being tested
patient activation training, Usual care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • patient activation trainingBehavioural

    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 careOther

    Usual HIV care

Study groups in NCT02165735
Study groupRoleWhat they receive
patient activation trainingExperimentalPatient 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.
Receives: Behavioral: patient activation training
Usual CareExperimentalUsual care for HIV
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline and 1 year

Secondary outcomes (10)
  1. Change in eHealth Literacy Scale (eHEALS)

    Our first secondary outcome measure is eHealth literacy based on changes in the eHealth Literacy Scale or eHEALS. The eHealth Literacy Scale (eHEALS) is an 8-item measure that assesses patient comfort, knowledge, and skills at finding health information on the internet and evaluating whether or not it is reliable. People who score high on the eHEALS normally are very comfortable finding reliable information on the internet. The scores for the 8-item measure range in value from 8-40, with higher scores indicating greater perceived skills at using online health information to help solve health problems.

    Measured: Baseline and 1 year

  2. Change in Decisional Self-Efficacy Scale (DSES)

    Our next secondary outcome measure is decision making based on changes in the Decisional Self-Efficacy Scale or DSES. The Decisional Self-Efficacy Scale (DSES) is an 11-item measure that assesses patient confidence in their ability to make health care decisions. People who score high on the DSES normally have an easier time making health care decisions. The scores for the 11-item measure range in value from 0-100, with higher scores indicating greater confidence in making an informed choice.

    Measured: Baseline and 1 year

  3. Change in Perceived Involvement in Care Scale (PICS)

    Our third secondary outcome measure is involvement in care based on changes in the Perceived Involvement in Care Scale or PICS. The Perceived Involvement in Care Scale (PICS) is an 8-item measure that assesses patient perceived proficiency in communicating concerning their health care with the doctor. People who score high on the PICS normally are satisfied with how well they feel they communicate with the doctor about their care. The scores for the 8-item measure range in value from 8-40, with higher scores indicating greater perceived involvement in their care.

    Measured: Baseline and 1 year

  4. Change in Instrument on Doctor Patient Communication Skills (IDPCS)

    Our fourth secondary outcome measure is clinician patient centeredness based on changes in the Instrument on Doctor Patient Communication Skills or IDPCS. The Instrument on Doctor Patient Communication Skills (IDPCS) is a 19-item measure that assesses patient perception of the doctor's communication proficiency with them. People who score high on the IDPCS normally are satisfied with the way the doctor speak with them about their care. The scores for the 19-item measure range in value from 19-95, with higher scores indicating greater quality communication by the doctor.

    Measured: Baseline and 1 year

  5. Change in HIV Adherence Self-Efficacy Scale (ASES)

    Our fifth secondary outcome measure is HIV adherence self-efficacy based on changes in the HIV Adherence Self-Efficacy Scale or ASES. The HIV Adherence Self-Efficacy Scale (ASES) is a 15-item measure that assesses patient self-efficacy for adherence to HIV treatment plan including but not limited to taking HIV medications. People who score high on the ASES normally are very confident of sticking to their HIV treatment plan even when it is hard. The scores for the 15-item measure range in value from 0-150, with higher scores indicating greater adherence self-efficacy.

    Measured: Baseline and 1 year

  6. Change in Self-Reported Adherence

    Our sixth secondary outcome measure is adherence to combination antiretroviral treatment (cART) based on changes on survey of recommended items for assessing self-reported antiretroviral adherence. Our survey included two recommended assessment items with the focus on one-item measure that assesses patient self-reported adherence to taking HIV medications. People who score high on the self-reported adherence cART normally are very confident of being more adherent to taking their HIV medications. The score for the one-item measure range in value from 0-100 percent, with higher scores indicating greater adherence to cART.

    Measured: Baseline and 1 year

  7. Change in Undetectable Viral Load

    Our seventh secondary outcome measure is undetectable viral load based on changes to participants' HIV viral load. The HIV viral load measurements were abstracted from the participants' personal health record (PHR). In our study, people who had a HIV viral load of <50 were considered to have undetectable viral load.

    Measured: Baseline and 1 year

  8. Change in Evidence-based Preventative Care

    Our eighth secondary outcome measure is prevention-seeking behavior based on chart abstracted information based on our preventive care index. We created a preventive care index for each participant by assigning one point of each intervention they received post-randomization divided by the total number of interventions for which they were eligible. The index included eleven preventive care measures: Human Papillomavirus, Influenza, Tetanus, Hepatitis A, B, C testing, Hepatitis A \& B vaccinations, cervical cancer screening (PAP), mammography and any colon cancer screening. People who score high on the evidence-based preventative care normally are more able to prevent illnesses or diseases. The score for the measure range in value from 0-1, with higher scores indicating greater ability to stay healthy.

    Measured: Baseline and 1 year

  9. Change in Short Form Health Survey: [Mental Health] (SF12)

    Our ninth secondary outcome measure is mental well-being and quality of life based on changes on the Short Form Health Survey or SF12. The Short Form Health Survey (SF12) is a 12-item measure with 6 items that assesses patient mental well-being/quality of life and 6 items that assesses patient physical well-being/quality of life. People who score high on the SF-12 are normally in good mental and physical health. The scores for the 12-item measure includes two scales whose range in value from 0-100, with higher scores indicating a better health state.

    Measured: Baseline and 1 year

  10. Change in Short Form Health Survey: [Physical Health] (SF12)

    Our final secondary outcome measure is physical well-being and quality of life based on changes on the Short Form Health Survey or SF12. The Short Form Health Survey (SF12) is a 12-item measure with 6 items that assesses patient mental well-being/quality of life and 6 items that assesses patient physical well-being/quality of life. People who score high on the SF-12 are normally in good mental and physical health. The scores for the 12-item measure includes two scales whose range in value from 0-100, with higher scores indicating a better health state.

    Measured: Baseline and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2014 (estimated)
  2. Study start20 Aug 2014
  3. Primary completion30 Nov 2016
  4. Study completion28 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02165735
Sponsor's protocol ID
AD-1306-03104
Acronym
GREAT
Status last verified
Feb 2019
First submitted
13 Jun 2014
Last updated
15 Mar 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 31240605
  • 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.

    PubMed 26474979

Questions about this trial

What is this clinical trial studying?

A study testing patient activation training in people with HIV, run by University of Rochester at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient Activation Measure (PAM) (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02165735, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Get Ready And Empowered About Treatment (NCT02165735) | AzTrials