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Patient Portal to Support Treatment Adherence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00923624
First Posted: June 18, 2009
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kaiser Permanente
  Purpose
The purpose of this study is to conduct a randomized control trial of a behavioral intervention delivered by nurses via an electronic medical record (EMR) patient web portal to determine if this is an efficacious method for supporting medication adherence.

Condition Intervention
Antiretroviral Medication Adherence Other: attention control Behavioral: adherence intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Portal to Support Treatment Adherence

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Lapses in medication adherence over the last 7 and 30 days (self report) and over previous 12 months (pharmacy records). [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Web service utilization. [ Time Frame: 12 months ]

Enrollment: 304
Study Start Date: June 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: staff emails
Attention control that includes staff sending emails with information about using health information technology system.
Other: attention control
9 informational email messages sent by study staff about the features of the shared electronic medical record system and how to use them.
Experimental: study nurse messages
A series of 6 proactive secure messages and 3 proactive booster messages (for a total of 9 secure and personalized messages) sent by the study nurse via the EMR patient web portal.
Behavioral: adherence intervention
9 messages tailored by the study nurse and guided by the IMB model

Detailed Description:
300 adult HIV+ patients will be randomized to one of two arms. 150 will be assigned to receive secure messages focused on antiretroviral adherence from a nurse through the health plan EMR patient website. 150 will be assigned to an attention control comparison arm, and will receive electronic messages from a study staff member that provide information about the various features of the health plan patient website. Patients will be invited by mail to be telephone screened for enrollment in the study. Patients will be provided the opportunity to opt out of being contacted by the study. Eligible and interested patients will be mailed an access code and separately emailed a link to a secure study website where they will complete a web consent form and a baseline web survey before being randomized to an intervention arm. This trial will allow us to evaluate the effectiveness of using health information technology as an intervention delivery vehicle to improve patient disease management behaviors such as treatment adherence.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • enrollment in GHC or KP health plans for at least 6 months
  • expect to stay enrolled for 1 year in health plan
  • HIV+
  • currently prescribed antiretroviral medication
  • regular access to a computer with internet capabilities and working email address and meet one of the following:
  • gap in antiretroviral prescription refills based on 6 month refill records
  • referral to study by provider team for adherence problems

Exclusion Criteria:

  • dementia or psychosis diagnosis documented in medical record
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00923624


Locations
United States, California
Kaiser Permanente Northern California
Oakland, California, United States, 94612
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
Investigators
Principal Investigator: Sheryl L. Catz, PhD Kaiser Permanente
  More Information

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00923624     History of Changes
Other Study ID Numbers: 5R01MH081750 ( U.S. NIH Grant/Contract )
First Submitted: June 17, 2009
First Posted: June 18, 2009
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Kaiser Permanente:
electronic medical record
antiretroviral medication adherence