Chronic Comorbid ConditionsPhase 3NCT01724125
An Electronic Personal Health Record for Mental Health Consumers
A Phase 3 study testing personal electronic medical record in people with Chronic Comorbid Conditions, run by Emory University at 1 site in United States.
Trial summary
Electronic Personal Health Records (PHRs) hold promise in helping reshape healthcare by shifting the ownership and locus of health records from being scattered across multiple providers to an approach that is longitudinal and patient-centered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Comorbid Conditions
- What is being tested?
- personal electronic medical record
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2011
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently in treatment at the CMHC.
- Serious Mental Illness: based on or chart review;
- One or more Chronic Medical Condition as ascertained via administrative records.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Electronic Personal Health Records (PHRs) hold promise in helping reshape healthcare by shifting the ownership and locus of health records from being scattered across multiple providers to an approach that is longitudinal and patient-centered. Given the complex health needs and the fragmentation of care for persons with serious mental illnesses, these individuals could derive particular benefit from a PHR. However, there are currently no established PHRs developed for use in this population.
In order to fill this gap, the investigators propose to develop, test, and disseminate a Personal Health Record for persons with serious mental illnesses and one or more comorbid medical condition. The Mental Health PHR (MH-PHR) builds on an established personal health record which was developed in partnership with medical consumers and is in wide use in a number of communities in the United States and abroad.
- Conditions
- Chronic Comorbid Conditions
- Being tested
- personal electronic medical record
- Keywords
- serious mental illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personal electronic medical recordOther
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | Assigned a Personal Electronic Health Record Receives: Other: personal electronic medical record |
| Control: Usual Care | Active comparator | Assigned to control arm, continued to receive care as usual in community. Was issued information on community health resources, but did not use research study personal health record. Receives: Other: personal electronic medical record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Care
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 posted9 Nov 2012 (estimated)
- Study startMar 2009
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Comorbid ConditionsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Benjamin Druss, Emory University
- Investigators
- Benjamin Druss, MD MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724125
- Sponsor's protocol ID
- IRB00012759
- Other IDs
- 1R18HS017829
- Status last verified
- Aug 2016
- First submitted
- 25 Apr 2012
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Electronic Personal Health Record for Mental Health Consumers
- ClinicalTrials.gov ID
- NCT01724125
- Acronym / sponsor ID
- IRB00012759
- Conditions
- Chronic Comorbid Conditions
- Keywords
- serious mental illness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Mar 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Nov 2012 (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.
Electronic Personal Health Records (PHRs) hold promise in helping reshape healthcare by shifting the ownership and locus of health records from being scattered across multiple providers to an approach that is longitudinal and patient-centered. Given the complex health needs and the fragmentation of care for persons with serious mental illnesses, these individuals could derive particular benefit from a PHR. However, there are currently no established PHRs developed for use in this population.
In order to fill this gap, the investigators propose to develop, test, and disseminate a Personal Health Record for persons with serious mental illnesses and one or more comorbid medical condition. The Mental Health PHR (MH-PHR) builds on an established personal health record which was developed in partnership with medical consumers and is in wide use in a number of communities in the United States and abroad.
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 |
|---|---|---|
| Case | Experimental | Other: personal electronic medical recordAssigned a Personal Electronic Health Record |
| Control: Usual Care | Active comparator | Other: personal electronic medical recordAssigned to control arm, continued to receive care as usual in community. Was issued information on community health resources, but did not use research study personal health record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Currently in treatment at the CMHC.
- Serious Mental Illness: based on or chart review;
- One or more Chronic Medical Condition as ascertained via administrative records.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| personal electronic medical record | Other | Case, Control: Usual Care |
Primary outcome
Quality of Care
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 5 Aug 2016.
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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.
Benjamin Druss, MD MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing personal electronic medical record in people with Chronic Comorbid Conditions, run by Emory University 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 3 inclusion and 0 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 5 Aug 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of Care (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.