Antiretroviral Medication AdherenceNCT00923624
Patient Portal to Support Treatment Adherence
A study testing adherence intervention in people with Antiretroviral Medication Adherence, run by Kaiser Permanente at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiretroviral Medication Adherence
- What is being tested?
- adherence intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- dementia or psychosis diagnosis documented in medical record
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente Northern California
Oakland, California, 94612
Group Health Research Institute
Seattle, Washington, 98101
About this study
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.
Read the 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.
- Conditions
- Antiretroviral Medication Adherence
- Being tested
- attention control, adherence intervention
- Keywords
- electronic medical record, antiretroviral medication adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attention controlOther
9 informational email messages sent by study staff about the features of the shared electronic medical record system and how to use them.
adherence interventionBehavioural
9 messages tailored by the study nurse and guided by the IMB model
| Study group | Role | What they receive |
|---|---|---|
| staff emails | Active comparator | Attention control that includes staff sending emails with information about using health information technology system. Receives: 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. Receives: Behavioral: adherence intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lapses in medication adherence over the last 7 and 30 days (self report) and over previous 12 months (pharmacy records).
Measured: 12 months
Secondary outcomes (1)
Web service utilization.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiretroviral Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheryl L. Catz, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923624
- Sponsor's protocol ID
- 5R01MH081750
- Other IDs
- 5R01MH081750
- Status last verified
- Oct 2017
- First submitted
- 17 Jun 2009
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Portal to Support Treatment Adherence
- ClinicalTrials.gov ID
- NCT00923624
- Acronym / sponsor ID
- 5R01MH081750
- Conditions
- Antiretroviral Medication Adherence
- Keywords
- electronic medical record, antiretroviral medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| staff emails | Active comparator | Other: attention controlAttention control that includes staff sending emails with information about using health information technology system. |
| study nurse messages | Experimental | Behavioral: adherence interventionA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (1 listed)
- dementia or psychosis diagnosis documented in medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| attention control9 informational email messages sent by study staff about the features of the shared electronic medical record system and how to use them. | Other | staff emails |
| adherence intervention9 messages tailored by the study nurse and guided by the IMB model | Behavioural | study nurse messages |
Primary outcome
Lapses in medication adherence over the last 7 and 30 days (self report) and over previous 12 months (pharmacy records).
Time frame: 12 months
1 secondary outcome
Web service utilization.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl L. Catz, PhD principal investigator
Kaiser Permanente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adherence intervention in people with Antiretroviral Medication Adherence, run by Kaiser Permanente 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 7 inclusion and 1 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 13 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lapses in medication adherence over the last 7 and 30 days (self report) and over previous 12 months (pharmacy records). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2017.