NCT00923624

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

3.3 years

First QC Date

June 17, 2009

Last Update Submit

October 11, 2017

Conditions

Keywords

electronic medical recordantiretroviral medication adherence

Outcome Measures

Primary Outcomes (1)

  • Lapses in medication adherence over the last 7 and 30 days (self report) and over previous 12 months (pharmacy records).

    12 months

Secondary Outcomes (1)

  • Web service utilization.

    12 months

Study Arms (2)

staff emails

ACTIVE COMPARATOR

Attention control that includes staff sending emails with information about using health information technology system.

Other: attention control

study nurse messages

EXPERIMENTAL

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

Interventions

9 informational email messages sent by study staff about the features of the shared electronic medical record system and how to use them.

staff emails

9 messages tailored by the study nurse and guided by the IMB model

study nurse messages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • dementia or psychosis diagnosis documented in medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Study Officials

  • Sheryl L. Catz, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2009

First Posted

June 18, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations