HypertensionmPHRNCT01890226
A Mobile Personal Health Record for Behavioral Health Homes
A study testing Mobile Personal Health Record App. in people with Hypertension and Hyperlipidemia, run by Emory University at 1 site in United States.
Trial summary
Poor quality of medical care is a major contributor to excess medical morbidity and premature mortality in persons with serious mental illnesses (SMI). To address this problem, community mental health providers are increasingly partnering with safety net medical providers to develop behavioral health homes, integrated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Hyperlipidemia, Diabetes
- What is being tested?
- Mobile Personal Health Record App.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- one or more of the following conditions: hyperlipidemia, hypertension, diabetes
- able to give consent
- patient in the behavioral health home
Who cannot join
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Viewpoint Health & Oakhurst Medical Center
Conyers, Georgia, 30012
About this study
Poor quality of medical care is a major contributor to excess medical morbidity and premature mortality in persons with serious mental illnesses (SMI). To address this problem, community mental health providers are increasingly partnering with safety net medical providers to develop behavioral health homes, integrated clinics in which persons with SMI receive coordinated medical and mental health care. However, behavioral health homes have faced logistical and privacy challenges in integrating electronic medical records across organizations.
This application proposes to develop and test a mobile Personal Health Record (mPHR) to overcome this problem while more fully engaging patients in their health care. The study will develop, test, and disseminate the mPHR. The investigators will develop the app building on experience and preliminary data from a PC-based PHR project, and link it to the medical and mental health EHR in a behavioral health home. Next, the investigators will conduct a randomized trial of the mPHR in 300 subjects randomized to the mPHR or usual care.
- Conditions
- Hypertension, Hyperlipidemia, Diabetes
- Being tested
- Mobile Personal Health Record App.
- Medical subject headings
- Hypertension, Hyperlipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Personal Health Record App.Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Experimental: Intervention | Experimental | Participants randomized to the intervention arm will receive the mobile personal health record. Receives: Behavioral: Mobile Personal Health Record App. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Quality Score
It is a measure of quality of care. The aggregate score represents the total number of eligible services received for an individual generated by dividing all instances in which recommended care was delivered by the number of times a participant was eligible for the indicator. The score ranges from 0 to 1 with higher scores indicating receipt of recommended care/services.
Measured: Baseline, 12 month post intervention
Secondary outcomes (3)
Change in Patient Assessment of Chronic Illness Care
20-item patient self-report instrument that assesses the extent to which patients with chronic illness report receiving care that aligns with the Chronic Care Model. The summary score ranges from 1 to 5 with a higher score indicating patient's perception of greater involvement in self-management and receipt of chronic care counseling.
Measured: Baseline, 6 month post intervention, 12 month post intervention
Change in Patient Activation Measure
Assesses a patients' perceived ability to manage their illnesses and their healthcare visits. Patient Activation Measure Scores were summed to calculate the overall raw score then transformed to an activation scale ranging from 0 to 100. Higher scores indicate greater patient activation.
Measured: Baseline, 6 month post intervention, 12 month post intervention
Change in Health-related Quality of Life
Measured using the Physical and Mental Component Summary scales of the SF-12. Assesses a patients' perceived health related quality of life.
The composite physical (PCS) and mental component (MCS) summary scores for the SF-12 are each scored on a 0-100 scale. Higher scores indicate better functioning.
Measured: Baseline, 6 month post intervention, 12 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startNov 2014
- Primary completionNov 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Benjamin Druss, Emory University
- Investigators
- Benjamin Druss, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890226
- Sponsor's protocol ID
- IRB00067447
- Other IDs
- 1R01MH100467-01
- Acronym
- mPHR
- Status last verified
- Feb 2020
- First submitted
- 25 Jun 2013
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Druss BG, Li J, Tapscott S, Lally CA. Randomized Trial of a Mobile Personal Health Record for Behavioral Health Homes. Psychiatr Serv. 2020 Aug 1;71(8):803-809. doi: 10.1176/appi.ps.201900381. Epub 2020 May 4.
PubMed 32362226
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Personal Health Record for Behavioral Health Homes
- ClinicalTrials.gov ID
- NCT01890226
- Acronym / sponsor ID
- mPHR / IRB00067447
- Conditions
- Hypertension, Hyperlipidemia, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2014
- Primary completion
- Nov 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Posted 30 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Poor quality of medical care is a major contributor to excess medical morbidity and premature mortality in persons with serious mental illnesses (SMI). To address this problem, community mental health providers are increasingly partnering with safety net medical providers to develop behavioral health homes, integrated clinics in which persons with SMI receive coordinated medical and mental health care. However, behavioral health homes have faced logistical and privacy challenges in integrating electronic medical records across organizations.
This application proposes to develop and test a mobile Personal Health Record (mPHR) to overcome this problem while more fully engaging patients in their health care. The study will develop, test, and disseminate the mPHR. The investigators will develop the app building on experience and preliminary data from a PC-based PHR project, and link it to the medical and mental health EHR in a behavioral health home. Next, the investigators will conduct a randomized trial of the mPHR in 300 subjects randomized to the mPHR or usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Experimental: Intervention | Experimental | Behavioral: Mobile Personal Health Record App.Participants randomized to the intervention arm will receive the mobile 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)
- one or more of the following conditions: hyperlipidemia, hypertension, diabetes
- able to give consent
- patient in the behavioral health home
Key exclusion criteria (1 listed)
- Unable to give consent
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 |
|---|---|---|
| Mobile Personal Health Record App. | Behavioural | Experimental: Intervention |
Primary outcome
Change in Composite Quality Score
Time frame: Baseline, 12 month post intervention
It is a measure of quality of care. The aggregate score represents the total number of eligible services received for an individual generated by dividing all instances in which recommended care was delivered by the number of times a participant was eligible for the indicator. The score ranges from 0 to 1 with higher scores indicating receipt of recommended care/services.
3 secondary outcomes
Change in Patient Assessment of Chronic Illness Care
Time frame: Baseline, 6 month post intervention, 12 month post intervention
Change in Patient Activation Measure
Time frame: Baseline, 6 month post intervention, 12 month post intervention
Change in Health-related Quality of Life
Time frame: Baseline, 6 month post intervention, 12 month post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32362226Druss BG, Li J, Tapscott S, Lally CA. Randomized Trial of a Mobile Personal Health Record for Behavioral Health Homes. Psychiatr Serv. 2020 Aug 1;71(8):803-809. doi: 10.1176/appi.ps.201900381. Epub 2020 May 4.
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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 study testing Mobile Personal Health Record App. in people with Hypertension and Hyperlipidemia, 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 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 17 Feb 2020. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Composite Quality Score (time frame: Baseline, 12 month post intervention). 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 NCT01890226, 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 17 Feb 2020.