Trial record 17 of 50 for:    " September 02, 2009":" October 02, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Trial Embedded in an Electronic Personal Medical Health Records

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00972348
First received: September 3, 2009
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
HIV Infections
Health Literacy
Other: Online access to a personal health record
Other: No access to the PHR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial Embedded in an Electronic Medical Record (myHERO).

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 months of participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alleviation of depression, among patients who are depressed at baseline. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Smoking cessation, among patients who are smokers at baseline. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Trust between physicians and patients. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Medication reconciliation. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 338
Study Start Date: July 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Access to Personal Health Record
Full access to the Personal Health Record including lists of diagnoses, medications and laboratory values.
Other: Online access to a personal health record
Patients in the intervention arm have full access to their online personal health record
Active Comparator: No access to the PHR
No access to the PHR but patients will complete surveys.
Other: No access to the PHR
Patients will not be given access to their PHR but will complete online surveys.

Detailed Description:

HIV/AIDS is a non-curable chronic illness. Applying the chronic care model (CCM) to this disease may lead to improved outpatient based health care and easier clinical transitions for HIV infected patients. Clinical information systems (CIS) are a key element in the CCM and have three important roles: reminder systems; feedback mechanisms; and registries. CIS have focused on the provider as the recipient of critical data, however clinical information systems that target patients as consumers of information might also contribute to improved health care, especially for ambulatory patients. Personal health records (PHRs) are tools that would fit as a clinical information system for patients. PHRs allow patients (and others) to view data that are necessary to guide practical outpatient decisions. PHRs can become platforms to support the CIS elements too, allowing patients to receive and understand information, engage in their healthcare and influence their health outcomes. Our central hypothesis is that a secure enhanced PHR (ePHR) that combines meaningful information, web-based tools for support and reminders for patients will also provide a substantial opportunity to promote self-management and will lead to improved health outcomes. In this proposal we will work directly with HIV/AIDS patients in a public health setting to model processes that contribute to improved health outcomes in the realms of patient behaviors, patient-clinician trust, clinical outcomes, medication safety and utilization. Accordingly, the specific aims are:

  1. (Build Infrastructure and Content) Extend and secure a web-based PHR for HIV/AIDS patients receiving care in a public health setting providing these users with tools to access and understand their medical record including resources for decision support, information retrieval and communication. Specific content will include access to support for tobacco cessation, depression abatement, anxiety reduction, and medication adherence improvement.
  2. (Evaluation of PHR) Evaluation of patient and clinician experience with PHR including patient access and use patterns including use of support for tobacco cessation, depression abatement, anxiety reduction, adherence improvement., patient and clinician satisfaction with ePHR.
  3. (Outcome Assessment) Evaluation in 5 domains: quality of the patient-clinician interaction (trust, communication, health promotion); changes in patient behaviors (risk behaviors, adherence to antiretroviral medications, tobacco use); clinical outcomes (CD4+ T-lymphocytes, detectable plasma HIV RNA, depression, anxiety, quality of life); safety (documentation of drug allergies, adverse events, medication reconciliation); and utilization (office visits).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Evidence of HIV-1 infection, based on patient's medical history or laboratory tests.
  2. 18 years of age or older
  3. Receiving primary medical care at the Positive Health Program, SFGH.
  4. Able and willing to give informed consent.
  5. Willing to use the patient portal

Exclusion Criteria:

  1. Unwilling or unable to provide informed consent.
  2. No access to the web at any convenient location.
  3. Not willing to respond to online surveys or questionnaires.
  4. Already with access to the myHERO system
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972348

Locations
United States, California
HIV AIDS outpatient clinic at Ward 86
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: James Kahn, MD University of California
Study Director: David Thom, MD, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00972348     History of Changes
Other Study ID Numbers: H2598-33964, R18 HS17784
Study First Received: September 3, 2009
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
HIV
Personal Health Record
Laboratory values: CD4 cells and HIV Viral load
Medication Reconciliation

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 23, 2014