Randomized Controlled Trial Using Patient Reported Outcomes and Care Managers to Improve HIV Medication Adherence in Routine Clinical Care
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|ClinicalTrials.gov Identifier: NCT01505660|
Recruitment Status : Unknown
Verified April 2015 by Heidi Crane, University of Washington.
Recruitment status was: Active, not recruiting
First Posted : January 6, 2012
Last Update Posted : April 14, 2015
|Condition or disease||Intervention/treatment|
|HIV||Behavioral: Care management|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|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|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2015|
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.
- Self-reported adherence [ Time Frame: up to 1 year after enrollment ]
- HIV-1 RNA level [ Time Frame: up to 1 year after enrollment ]
- Self-reported substance use [ Time Frame: Up to 1 year after enrollment ]
- Health related quality of life [ Time Frame: Up to 1 year after enrollment ]
- Physical activity levels [ Time Frame: up to 1 year after enrollment ]
- Self-reported depression [ Time Frame: Up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505660
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98125|
|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|