Cardiovascular RiskSMART PHRNCT01078532
Self Management and Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (PHR)
A study testing SMART PHR in people with Cardiovascular Risk, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Risk
- What is being tested?
- SMART PHR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,815 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=18, if they have medically complex diseases that increase cardiovascular risk not yet a PHR user
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Primary Care practices
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Self Management & Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (SMART 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 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.
- Conditions
- Cardiovascular Risk
- Being tested
- SMART PHR, usual care
- Keywords
- medically complex diseases that increase cardiovascular risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART PHROther
Patient receives an active PHR
usual careOther
Usual passive PHR
| Study group | Role | What they receive |
|---|---|---|
| SMART PHR | Experimental | Patients receive the active PHR Receives: Other: SMART PHR |
| Passive PHR | Other | Usual PHR Care Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved targeted chronic disease outcomes
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.
Measured: 1 year
Secondary outcomes (2)
change in value in these outcome measures (lipid levels, blood pressure, and A1c levels)
Measured: 1 year
rates of adherence to diagnostic and therapeutic recommendations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular RiskStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,815 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Mark S Roberts, MD, MPP, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078532
- Sponsor's protocol ID
- HS018167
- Acronym
- SMART PHR
- Status last verified
- May 2014
- First submitted
- 27 Feb 2010
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hess R, Fischer GS, Sullivan SM, Dong X, Weimer M, Zeith C, Clark S, Roberts MS. Patterns of response to patient-centered decision support through a personal health record. Telemed J E Health. 2014 Nov;20(11):984-9. doi: 10.1089/tmj.2013.0332. Epub 2014 Sep 22.
PubMed 25243350
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Management & Reminders With Technology: SMART Appraisal of an Integrated Personal Health Record (SMART PHR)
- ClinicalTrials.gov ID
- NCT01078532
- Acronym / sponsor ID
- SMART PHR / HS018167
- Conditions
- Cardiovascular Risk
- Keywords
- medically complex diseases that increase cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,815 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART PHR | Experimental | Other: SMART PHRPatients receive the active PHR |
| Passive PHR | Other | Other: usual careUsual PHR Care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >=18, if they have medically complex diseases that increase cardiovascular risk not yet a PHR user
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART PHRPatient receives an active PHR | Other | SMART PHR |
| usual careUsual passive PHR | Other | Passive PHR |
Primary outcome
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.
2 secondary outcomes
change in value in these outcome measures (lipid levels, blood pressure, and A1c levels)
Time frame: 1 year
rates of adherence to diagnostic and therapeutic recommendations
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
- Derived from this study: PubMed 25243350Hess R, Fischer GS, Sullivan SM, Dong X, Weimer M, Zeith C, Clark S, Roberts MS. Patterns of response to patient-centered decision support through a personal health record. Telemed J E Health. 2014 Nov;20(11):984-9. doi: 10.1089/tmj.2013.0332. Epub 2014 Sep 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Roberts, MD, MPP principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART PHR in people with Cardiovascular Risk, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improved targeted chronic disease outcomes (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01078532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.