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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: Completed NA study, sponsored by University of Pittsburgh.
NCT01078532 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 1,815 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT01078532 record still lists
NCT01078532 is an interventional study that assigns participants to a tested intervention. Its 1,815 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 2 interventions - of which usual care is the first listed.
NCT01078532 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01078532's enrollment target sits among peer trials
1,815 57th of 2000 higher than 1,944 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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