Diabetes MellitusEMPOWER-DNCT00542204
Use of Online Personalized Health Record System to Promote Self-Management of Diabetes
A study testing Online disease management in people with Diabetes Mellitus, run by Palo Alto Medical Foundation at 6 sites in United States.
Trial summary
Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable proportion of Americans with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Online disease management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2008to Aug 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years of age
- Have a designated Palo Alto Medical Foundation Primary Care Provider (PCP)
- Seen in primary or specialty care at the Palo Alto Division at least once in the preceding 24 months
- Diagnosis of diabetes
- Baseline A1C >= 7.5%
Who cannot join
- Initial diagnosis of diabetes within the last 12 months
- Diagnosis of Type 1 diabetes
- Inability to speak and read in English
- Lack of regular access to a computer with Internet and email capabilities
- Unwilling to perform any self-monitoring at home, including blood glucose and blood pressure%
- Pregnant, planning to become pregnant, or lactating
Show all 9Show fewer
- Currently enrolled in a care management program at Palo Alto Medical Foundation or elsewhere
- PCP determination that the study is inappropriate or unsafe for the patient
- Investigator discretion for clinical safety or protocol adherence reasons
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
PAMF Palo Alto Health Care Division
Fremont, California, 94538
PAMF Palo Alto Health Care Division
Los Altos, California, 94022
PAMF Camino Region
Mountain View, California, 94040
PAMF Palo Alto Health Care Division
Palo Alto, California, 94301
PAMF Palo Alto Health Care Division
Redwood City, California, 94063
PAMF Santa Cruz Medical Clinic
Santa Cruz, California, 95062
About this study
Official title: Patient-Centered Online Disease Management Using a Personal Health Record System
Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable proportion of Americans with diabetes. To further reduce the treatment and adherence gaps in diabetes care, the researchers propose to evaluate a Customized, Continuous Care Management (CCCM) program that actively supports a partnership between the patient and his/her multidisciplinary care management (CM) team using an online disease management (ODM) system, which is integrated with a comprehensive electronic health record (EHR) system that includes a personal health record and secure patient-clinician messaging capabilities. The CCCM program builds upon CM strategies proven effective in past studies and creates an ODM system that is built upon and fully integrated with a leading, commercially available EHR product - providing a blueprint for instituting customized, continuous care management for many different chronic conditions in a range of ambulatory care settings.
- Conditions
- Diabetes Mellitus
- Being tested
- Online disease management
- Keywords
- Diabetes, Blood Glucose Self-Monitoring, Home Blood Glucose Monitoring, Internet, Personal Health Record (PHR), Health Information Technology (HIT), Care management, Disease Management, Diabetes self-management, Consumer Health Information, Medical Records Systems, Computerized, Computerized Medical Records System, Automated Medical Records System, Electronic Health Record (EHR), Remote patient monitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online disease managementBehavioural
Also called EMPOWER-D
The Personalized Health Care Program couples a multidisciplinary care management team with an EHR-integrated Online Disease Management (ODM) system.
| Study group | Role | What they receive |
|---|---|---|
| Online disease management | Experimental | The PAMFOnline-mediated Personalized Health Care Program, which couples a multidisciplinary diabetes care management team with an EHR-integrated Online Disease Management (ODM) system. Receives: Behavioral: Online disease management |
| Usual care | No intervention | Usual medical care. No access to the PHCP electronic system and self-management tools supporting this care management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
Measured: Baseline, 6 months and 12 months
Secondary outcomes (5)
Self-management practices(e.g., medication adherence, home monitoring of glucose and BP, diet, and exercise)
Measured: Baseline, 6 months and 12 months
Processes of care (e.g., frequency of lab testing)
Measured: Baseline, 6 months and 12 months
Cardiovascular risk (e.g., blood pressure and lipids)
Measured: Baseline, 6 months and 12 months
Patient experience and satisfaction (e.g., relevant CAHPS measures)
Measured: Baseline and 12 months
Patient psychosocial well-being (e.g., diabetes-related emotional distress)
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startMar 2008
- Primary completionMar 2011
- Study completionAug 2011
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 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Sutter Health
- Responsible party
- Principal investigator, Paul Tang, Palo Alto Medical Foundation
- Investigators
- Paul Tang, M.D., Principal investigator, Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542204
- Sponsor's protocol ID
- 1R18HS017179-01
- Acronym
- EMPOWER-D
- Status last verified
- Apr 2015
- First submitted
- 9 Oct 2007
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tang PC, Overhage JM, Chan AS, Brown NL, Aghighi B, Entwistle MP, Hui SL, Hyde SM, Klieman LH, Mitchell CJ, Perkins AJ, Qureshi LS, Waltimyer TA, Winters LJ, Young CY. Online disease management of diabetes: engaging and motivating patients online with enhanced resources-diabetes (EMPOWER-D), a randomized controlled trial. J Am Med Inform Assoc. 2013 May 1;20(3):526-34. doi: 10.1136/amiajnl-2012-001263. Epub 2012 Nov 20.
PubMed 23171659
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Online Disease Management Using a Personal Health Record System
- ClinicalTrials.gov ID
- NCT00542204
- Acronym / sponsor ID
- EMPOWER-D / 1R18HS017179-01
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes, Blood Glucose Self-Monitoring, Home Blood Glucose Monitoring, Internet, Personal Health Record (PHR), Health Information Technology (HIT), Care management, Disease Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Palo Alto Medical FoundationUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Sutter Health
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Oct 2007 (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.
Diabetes is a major, growing, and costly chronic disease in the U.S., and implementation of recommended diabetes care remains poor, not merely suboptimal, and varied for a sizable proportion of Americans with diabetes. To further reduce the treatment and adherence gaps in diabetes care, the researchers propose to evaluate a Customized, Continuous Care Management (CCCM) program that actively supports a partnership between the patient and his/her multidisciplinary care management (CM) team using an online disease management (ODM) system, which is integrated with a comprehensive electronic health record (EHR) system that includes a personal health record and secure patient-clinician messaging capabilities. The CCCM program builds upon CM strategies proven effective in past studies and creates an ODM system that is built upon and fully integrated with a leading, commercially available EHR product - providing a blueprint for instituting customized, continuous care management for many different chronic conditions in a range of ambulatory care settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online disease management | Experimental | Behavioral: Online disease managementThe PAMFOnline-mediated Personalized Health Care Program, which couples a multidisciplinary diabetes care management team with an EHR-integrated Online Disease Management (ODM) system. |
| Usual care | No intervention | –Usual medical care. No access to the PHCP electronic system and self-management tools supporting this care management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >= 18 years of age
- Have a designated Palo Alto Medical Foundation Primary Care Provider (PCP)
- Seen in primary or specialty care at the Palo Alto Division at least once in the preceding 24 months
- Diagnosis of diabetes
- Baseline A1C >= 7.5%
Key exclusion criteria (9 listed)
- Initial diagnosis of diabetes within the last 12 months
- Diagnosis of Type 1 diabetes
- Inability to speak and read in English
- Lack of regular access to a computer with Internet and email capabilities
- Unwilling to perform any self-monitoring at home, including blood glucose and blood pressure%
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 |
|---|---|---|
| Online disease managementAlso: EMPOWER-DThe Personalized Health Care Program couples a multidisciplinary care management team with an EHR-integrated Online Disease Management (ODM) system. | Behavioural | Online disease management |
Primary outcome
Hemoglobin A1C
Time frame: Baseline, 6 months and 12 months
5 secondary outcomes
Self-management practices(e.g., medication adherence, home monitoring of glucose and BP, diet, and exercise)
Time frame: Baseline, 6 months and 12 months
Processes of care (e.g., frequency of lab testing)
Time frame: Baseline, 6 months and 12 months
Cardiovascular risk (e.g., blood pressure and lipids)
Time frame: Baseline, 6 months and 12 months
Patient experience and satisfaction (e.g., relevant CAHPS measures)
Time frame: Baseline and 12 months
Patient psychosocial well-being (e.g., diabetes-related emotional distress)
Time frame: Baseline, 6 months and 12 months
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 28 Apr 2015.
- Derived from this study: PubMed 23171659Tang PC, Overhage JM, Chan AS, Brown NL, Aghighi B, Entwistle MP, Hui SL, Hyde SM, Klieman LH, Mitchell CJ, Perkins AJ, Qureshi LS, Waltimyer TA, Winters LJ, Young CY. Online disease management of diabetes: engaging and motivating patients online with enhanced resources-diabetes (EMPOWER-D), a randomized controlled trial. J Am Med Inform Assoc. 2013 May 1;20(3):526-34. doi: 10.1136/amiajnl-2012-001263. Epub 2012 Nov 20.
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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.
Paul Tang, M.D. principal investigator
Palo Alto Medical Foundation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online disease management in people with Diabetes Mellitus, run by Palo Alto Medical Foundation at 6 sites 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 5 inclusion and 9 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 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Hemoglobin A1C (time frame: Baseline, 6 months and 12 months). 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 NCT00542204, 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 28 Apr 2015.