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Self Management and Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (PHR) (SMART PHR)

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. Identifier: NCT01078532
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : May 21, 2014
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
This project seeks to improve health care outcomes in complex patients with cardiovascular disease (CVD) or who are at high risk for developing CVD by promoting patient self-management. This will be accomplished in 4 diverse, large primary care practices through the following 3 aims: (1) develop a patient-specific, active component to an existing electronic PHR directed towards patients with complex illnesses that is designed to reduce the risk of cardiovascular disease, (2) conduct a randomized controlled trial of the effectiveness of passive and active PHRs for improving adherence and clinical outcomes of complex patients in an ambulatory environment, and (3) enumerate the barriers and facilitators to implementation and use of an PHR among providers and patients in an ambulatory setting. To accomplish the aim 1, a users group will be assembled to determine which potential features of an 'active PHR' would be most acceptable and useful to them. To accomplish the 2nd aim, 1,000 patients with complex chronic disease leading to increased cardiovascular risk (i.e., CVD or 2 of the 4 conditions of hypertension (HTN), diabetes mellitus (DM), or hyperlipidemia requiring at least one medication for control) will be randomized to a passive PHR (n=500), or an active PHR (n=500) at 4 sites where the PHR currently is installed and in use. Outcomes to be assessed include improvement in control of risk factors (e.g., blood pressure), frequency of compliance with testing guidelines (e.g., annual dilated retinal exams in DM), and clinical outcomes (e.g., myocardial infarction, hospitalizations). Aim 3 will be accomplished by surveying all participants using the PHR, along with nurses and physicians at the study sites, and by conducting focus groups of PHR participants, nurses, and physicians to determine the most useful features of the PHR and to barriers and facilitators of use.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Other: SMART PHR Other: usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1815 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Self Management & Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (SMART PHR)
Study Start Date : April 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SMART PHR
Patients receive the active PHR
Patient receives an active PHR

Passive PHR
Usual PHR Care
Other: usual care
Usual passive PHR

Primary Outcome Measures :
  1. improved targeted chronic disease outcomes [ Time Frame: 1 year ]
    blood pressure and low density lipoprotein level (LDL) in all patients, and A1C in patients who have diabetes. For patients on medications requiring monitoring of electrolytes and creatinine, we will look at changes in these parameters as well.

Secondary Outcome Measures :
  1. change in value in these outcome measures (lipid levels, blood pressure, and A1c levels) [ Time Frame: 1 year ]
  2. rates of adherence to diagnostic and therapeutic recommendations [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >=18, if they have medically complex diseases that increase cardiovascular risk not yet a PHR user

Exclusion Criteria:

  • current PHR user life-expectancy of less than 6 months dementia or disability that prevents them from being able to utilize a PHR (such as blindness)

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 identifier (NCT number): NCT01078532

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United States, Pennsylvania
UPMC Primary Care practices
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Agency for Healthcare Research and Quality (AHRQ)
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Principal Investigator: Mark S Roberts, MD, MPP University of Pittsburgh
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Pittsburgh Identifier: NCT01078532    
Other Study ID Numbers: HS018167
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
Keywords provided by University of Pittsburgh:
medically complex diseases that increase cardiovascular risk