Trial record 14 of 24 for:    " December 21, 2011":" January 20, 2012"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Washington.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Heidi Crane, University of Washington
ClinicalTrials.gov Identifier:
NCT01505660
First received: January 4, 2012
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

Among HIV-infected patients, adherence to antiretroviral medications is one of the most important determinants of clinical outcomes including viral suppression, viral resistance, disease progression, and death. Unfortunately poor adherence among patients with HIV is very common, mean levels of adherence in clinical cohorts are 60-75% or less. Alcohol, drug abuse, and mental illness particularly depression symptoms are key predictors of poor adherence, common among HIV-infected individuals, and important to identify and treat among nonadherent patients. This study will examine the ability of patient reported outcomes (PROs) and a targeted care management approach to improve clinical outcomes with a randomized controlled trial (RCT) in routine clinical care of patients with HIV. The investigators will determine whether healthcare delivery team notification of PROs including antiretroviral medication adherence and barriers of adherence such as depression and substance abuse along with tailored intervention recommendations and targeted care management leads to improvement in both process and clinical outcomes including patient-reported outcomes. The investigators will examine process outcomes such as use of clinic support services, and patient outcomes such as improvement in adherence, substance use, depression, and HIV-1 RNA levels.


Condition Intervention
HIV
Behavioral: Care management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Self-reported adherence [ Time Frame: up to 1 year after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HIV-1 RNA level [ Time Frame: up to 1 year after enrollment ] [ Designated as safety issue: No ]
  • Self-reported substance use [ Time Frame: Up to 1 year after enrollment ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: Up to 1 year after enrollment ] [ Designated as safety issue: No ]
  • Physical activity levels [ Time Frame: up to 1 year after enrollment ] [ Designated as safety issue: No ]
  • Self-reported depression [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Patients not randomized to the intervention will receive usual care which includes a patient reported outcomes assessment every 6 months as part of routine clinical procedures and patient-initiated interactions with case managers.
Experimental: Care management
The intervention will include frequent healthcare delivery team notification of PROs including medication adherence and adherence barriers such as depression symptoms along with tailored intervention recommendations and targeted care management using a stepped care approach.
Behavioral: Care management
The intervention will include healthcare delivery team notification of patient reported outcomes (PROs) including medication adherence and adherence barriers such as depression symptoms along with intervention recommendations and targeted care management using a stepped care approach. Patients will receive structured calls from their care manager 2 and 6 weeks after enrollment. An assessment including depression, adherence, and substance use will be completed at the beginning of each call. After the 2nd call, a stepped care approach will be used where patients with a greater need based on adherence and depression will receive more intensive interventions based on the PEARL intervention. The components include: a) problem solving treatment, b) social and physical activation, c) pleasant events scheduling, d) patient support and education regarding medication use, and e) medical and psychiatric consultation. Patients will also receive follow-up calls at ~9 and 12 months after enrollment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV-infected individuals
  • English speaking
  • 18 years of age or older
  • Access to either a home phone or cell phone at enrollment
  • In care at least 6 months.
  • Self-reported inadequate adherence based on routine clinic assessment

Exclusion Criteria:

  • Do not speak English
  • Not receiving antiretroviral medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505660

Contacts
Contact: Heidi M Crane, MD, MPH 206-744-6649 hcrane@uw.edu
Contact: Rob Fredericksen, PhD rfrederi@uw.edu

Locations
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98125
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Heidi M Crane, MD, MPH University of Washington
Principal Investigator: Paul K Crane, MD MPH University of Washington
Principal Investigator: Donald Patrick, PhD University of Washington
  More Information

No publications provided

Responsible Party: Heidi Crane, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01505660     History of Changes
Other Study ID Numbers: 41128-K, R01MH084759, U01AR057954, ADH HIV001
Study First Received: January 4, 2012
Last Updated: January 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Adherence
Depression
Care management
Stepped care
HIV
Patient reported outcomes
Antiretroviral medication adherence

ClinicalTrials.gov processed this record on August 26, 2014