NCT00972348

Brief Summary

This is a research study to determine if a personal health record, called myHERO, will help improve health. A personal health record is a secure internet (also called online) tool that contains personal health information like medications, diagnosed conditions, allergies and laboratory values (like CD4 cells and viral load). This study will also help explain if a personal health record influences the relationship with a doctor or nurse practitioner and their patients. The purpose of this study is to determine if a personal health record will influence health. The content of your personal health record is as secure as possible for any online health information.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
338

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

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

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 20, 2013

Status Verified

November 1, 2013

Enrollment Period

2.6 years

First QC Date

September 3, 2009

Last Update Submit

November 18, 2013

Conditions

HIV InfectionsHealth Literacy

Keywords

HIVPersonal Health RecordLaboratory values: CD4 cells and HIV Viral loadMedication Reconciliation

Outcome Measures

Primary Outcomes (1)

  • The primary analyses of the trial data will compare the two study groups with respect to (1) 12-month change in CD4 T-cell count and (2) 12-month proportion of patients whose HIV viral load (VL) level is detectable.

    12 months of participation

Secondary Outcomes (4)

  • Alleviation of depression, among patients who are depressed at baseline.

    12 months

  • Smoking cessation, among patients who are smokers at baseline.

    12 months

  • Trust between physicians and patients.

    12 months

  • Medication reconciliation.

    12 months

Study Arms (2)

Access to Personal Health Record

EXPERIMENTAL

Full access to the Personal Health Record including lists of diagnoses, medications and laboratory values.

Other: Online access to a personal health record

No access to the PHR

ACTIVE COMPARATOR

No access to the PHR but patients will complete surveys.

Other: No access to the PHR

Interventions

Online access to a personal health recordOTHER

Patients in the intervention arm have full access to their online personal health record

Access to Personal Health Record
No access to the PHROTHER

Patients will not be given access to their PHR but will complete online surveys.

No access to the PHR

Eligibility Criteria

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

You may qualify if:

  • Evidence of HIV-1 infection, based on patient's medical history or laboratory tests.
  • years of age or older
  • Receiving primary medical care at the Positive Health Program, SFGH.
  • Able and willing to give informed consent.
  • Willing to use the patient portal

You may not qualify if:

  • Unwilling or unable to provide informed consent.
  • No access to the web at any convenient location.
  • Not willing to respond to online surveys or questionnaires.
  • Already with access to the myHERO system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HIV AIDS outpatient clinic at Ward 86

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • James Kahn, MD

    University of California

    PRINCIPAL INVESTIGATOR

  • David Thom, MD, PhD

    University of California, San Francisco

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

July 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

November 20, 2013

Record last verified: 2013-11

Locations

US(1)