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NCT01078532 · ClinicalTrials.gov registry record · NA
Self Management and Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (PHR)
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 1,815
- Enrollment target
NCT01078532 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 1,815 participants.
The verdict
NCT01078532, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,815 participants
- Enrollment target
Study 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.
Interventions
- OTHER usual care
- OTHER SMART PHR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,815 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01078532
The ClinicalTrials.gov registry entry for NCT01078532 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,815 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which usual care is the first listed.
NCT01078532 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01078532 about?
NCT01078532 is a clinical study titled "Self Management and Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (PHR)". 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 p...
What is the current status of trial NCT01078532?
This trial is currently completed. It is a NA study. The enrollment target is 1,815 participants. The study started on 2010-04. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01078532?
The interventions under investigation include: usual care (OTHER), SMART PHR (OTHER).
Who is sponsoring clinical trial NCT01078532?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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