Diabetes MellitusPhase 1NCT00221455
The Potential of Technology to Improve Chronic Disease Management and Quality of Care
A Phase 1 study testing Patient diabetic self-management using the diabetic patient portal tools and A variety of educational interventions for non-adopters of the technology, and for non-compliant patients. in people with Diabetes Mellitus, run by Robert Wood Johnson Foundation at 1 site in United States.
Trial summary
We seek to determine if patient data entry, data entered based alerts, and data review in a secure patient portal may provide a sustainable approach to improve diabetic outcomes in a cost effective manner. We plan to study the extent to which the portal can improve diabetic outcomes and quality of care. 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?
- Patient diabetic self-management using the diabetic patient portal tools and A variety of educational interventions for non-adopters of the technology, and for non-compliant patients.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Sep 2007
- Phase
- Phase 1
- 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
Inclusion Criteria: Diabetic patients 18 years of age or older with an established primary care physician at the Cleveland Clinic Foundation
Exclusion Criteria: An individual not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
We seek to determine if patient data entry, data entered based alerts, and data review in a secure patient portal may provide a sustainable approach to improve diabetic outcomes in a cost effective manner. We plan to study the extent to which the portal can improve diabetic outcomes and quality of care. We recognize, however, that some patients will be more predisposed to adopting technology and some will be more predisposed to improving their compliance than others. Hence, we will also develop and test interventions that may improve adoption and compliance. The goals of the proposed study are: 1) to assess whether a web portal will improve care outcomes in diabetic patients; 2a) to describe the characteristics of patients whose health behavior improves over the study period; 2b) to describe the characteristics of patients who adopt the web portal-based disease management technology; 3) to develop and test targeted interventions to increase the adoption of the web portal and improve patient health behavior; and 4) to monitor the ongoing costs associated with the web portal and patient healthcare resource utilization, and to monitor the incremental costs of the interventions designed to improve utilization of the technology and patient compliance with their diabetic regimens.
Read the detailed description
To date, limited research has been conducted to determine if health information technology (HIT) is effective in improving the outcomes for patients with chronic diseases. Research is required to determine if interventions facilitated by an institutional EMR platform can be implemented such that they support patients with chronic diseases to achieve improved outcomes in a cost effective fashion.
At the Cleveland Clinic Foundation (CCF) an ambulatory EMR has been implemented to foster patient safety and institutional best practice guidelines, to facilitate research, and to achieve efficiencies in practice management. Our EMR is the foundation of the CCF patient portal. One of the functions of the portal is to allow patients to enter specific data elements that become part of their permanent medical record. Diabetics can enter and review their home glucometer readings, and view alert messages based on their entries. The entries are transferred to the patient's primary care physician's EMR In-Basket for review.
We recognize that some patients will be more predisposed to technology adoption and some will be more health behavior compliant than others. Therefore, in addition to studying our portal's efficacy in positive diabetic behavior change, we will test if interventions can assist less predisposed and less compliant patients to become more compliant and more inclined to adopt the technology.
The goals of the proposed study are:
- to assess whether a web portal will improve care outcomes in diabetic patients; 2a) to describe the characteristics of patients whose health behavior improves over the study period; 2b) to describe the characteristics of patients who adopt the web portal-based disease management technology; 3) to develop and test targeted interventions to increase the adoption of the web portal and improve patient health behavior; 4) to monitor the ongoing costs associated with the web portal and patient healthcare resource utilization, and to monitor the incremental costs of the interventions designed to improve utilization of the technology and patient compliance with their diabetic regimens.
- Conditions
- Diabetes Mellitus
- Being tested
- Patient diabetic self-management using the diabetic patient portal tools, A variety of educational interventions for non-adopters of the technology, and for non-compliant patients.
- Keywords
- Diabetes Mellitus, Chronic disease management, Patient portal, Patient empowerment
- Medical subject headings
- Diabetes Mellitus, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient diabetic self-management using the diabetic patient portal toolsBehavioural
A variety of educational interventions for non-adopters of the technology, and for non-compliant patients.Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome Measures: HbA1c, LDL,and the presence or absence of clinically significant proteinuria.
Secondary outcomes (1)
Technology Adoption will be measured by tracking the patient usage of the various portal features
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2004
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Wood Johnson Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Martin Harris, MD, MBA, Principal investigator, The Cleveland ClinicHolly D Miller, MD, MBA, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221455
- Sponsor's protocol ID
- 51760
- Other IDs
- 51760
- Status last verified
- Jul 2011
- First submitted
- 15 Sep 2005
- Last updated
- 27 Jul 2011
- Results posted
- No
Publications
Ajzen, I. (1991). The Theory of Planned Behavior. Organizational Behavior and Human Decision Processes, Vol. 50: 179-211.
Avital, M., Vandenbosch, B., (2000) IT-Business Ownership: The Missing Link for IT-Driven Value, Administrative Sciences Association of Canada - 2000 Proceedings (Information Systems), Vol. 21(4): 116-125.
Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. doi: 10.2337/diacare.26.3.917.
PubMed 12610059Beckles GL, Engelgau MM, Narayan KM, Herman WH, Aubert RE, Williamson DF. Population-based assessment of the level of care among adults with diabetes in the U.S. Diabetes Care. 1998 Sep;21(9):1432-8. doi: 10.2337/diacare.21.9.1432.
PubMed 9727887Biermann E, Dietrich W, Standl E. Telecare of diabetic patients with intensified insulin therapy. A randomized clinical trial. Stud Health Technol Inform. 2000;77:327-32.
PubMed 11187566Chang S., Ryoo S., Yu S., Ahn B., (1999) Development of an Internet-Based Home Monitoring System for Diabetes Mellitus, Proceeding of the 4th IEEE Malaysia International Conference on Communications and 4th IEEE Asia Pacific International Symposium on Consumer Electronics, Maleka, Malaysia, November 1999.
Chase HP, Pearson JA, Wightman C, Roberts MD, Oderberg AD, Garg SK. Modem transmission of glucose values reduces the costs and need for clinic visits. Diabetes Care. 2003 May;26(5):1475-9. doi: 10.2337/diacare.26.5.1475.
PubMed 12716807Eisenberg JM. Ten lessons for evidence-based technology assessment. JAMA. 1999 Nov 17;282(19):1865-9. doi: 10.1001/jama.282.19.1865. No abstract available.
PubMed 10573279Fishbein M., Ajzen I., (1975) Belief, Attitude, Intention and Behavior: An Introduction to Theory and Research. Reading, MA: Addison-Wesley.
Friedman RH, Stollerman JE, Mahoney DM, Rozenblyum L. The virtual visit: using telecommunications technology to take care of patients. J Am Med Inform Assoc. 1997 Nov-Dec;4(6):413-25. doi: 10.1136/jamia.1997.0040413.
PubMed 9391929Friedman RH, Stollerman J, Rozenblyum L, Belfer D, Selim A, Mahoney D, Steinbach S. A telecommunications system to manage patients with chronic disease. Stud Health Technol Inform. 1998;52 Pt 2:1330-4.
PubMed 10384677Gallagher, K., Vandenbosch, B., (2000) A Systemic View of Continual Change. Best Paper Proceedings of the Sixtieth Annual Meeting of the Academy of Management, August 2000.
Hailey D, Roine R, Ohinmaa A. Systematic review of evidence for the benefits of telemedicine. J Telemed Telecare. 2002;8 Suppl 1:1-30. doi: 10.1258/1357633021937604.
PubMed 12020415Hersh WR, Helfand M, Wallace J, Kraemer D, Patterson P, Shapiro S, Greenlick M. Clinical outcomes resulting from telemedicine interventions: a systematic review. BMC Med Inform Decis Mak. 2001;1:5. doi: 10.1186/1472-6947-1-5. Epub 2001 Nov 26.
PubMed 11737882Kwon H., Cho J, Kim H., Song B., Ko S., Lee J., Kim S., Chang S., Kim H., Cha B., Lee K., Son H., Lee J., Lee W., Yoon K., (2004) Establishment of Blood Glucose Monitoring System Using the Internet, Diabetes Care, Vol. 27(2):478-83. Mease A, Whitlock W, Brown A, (2000) Telemedicine Improved Diabetic Management. Military Medicine, Vol. 165:279-284. Neubauer A., Priglinger S., Ehrt O., (2001) Electronic Versus Paper-Based Patient Records: a Cost-Benefit Analysis, Ophthalmologe, Vol. 11:1083-8. Norris S., Engelgau M., Narayan K., (2001) Effectiveness of Self-Managed Training in Type 2 Diabetes: A Systematic Review of Randomized Controlled Trials, Diabetes Care, Vol. 24/3.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Technology to Improve Chronic Disease Management and Quality of Care
- ClinicalTrials.gov ID
- NCT00221455
- Acronym / sponsor ID
- 51760
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Chronic disease management, Patient portal, Patient empowerment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Robert Wood Johnson FoundationUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Sep 2005 (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.
We seek to determine if patient data entry, data entered based alerts, and data review in a secure patient portal may provide a sustainable approach to improve diabetic outcomes in a cost effective manner. We plan to study the extent to which the portal can improve diabetic outcomes and quality of care. We recognize, however, that some patients will be more predisposed to adopting technology and some will be more predisposed to improving their compliance than others. Hence, we will also develop and test interventions that may improve adoption and compliance. The goals of the proposed study are: 1) to assess whether a web portal will improve care outcomes in diabetic patients; 2a) to describe the characteristics of patients whose health behavior improves over the study period; 2b) to describe the characteristics of patients who adopt the web portal-based disease management technology; 3) to develop and test targeted interventions to increase the adoption of the web portal and improve patient health behavior; and 4) to monitor the ongoing costs associated with the web portal and patient healthcare resource utilization, and to monitor the incremental costs of the interventions designed to improve utilization of the technology and patient compliance with their diabetic regimens.
Detailed description
To date, limited research has been conducted to determine if health information technology (HIT) is effective in improving the outcomes for patients with chronic diseases. Research is required to determine if interventions facilitated by an institutional EMR platform can be implemented such that they support patients with chronic diseases to achieve improved outcomes in a cost effective fashion.
At the Cleveland Clinic Foundation (CCF) an ambulatory EMR has been implemented to foster patient safety and institutional best practice guidelines, to facilitate research, and to achieve efficiencies in practice management. Our EMR is the foundation of the CCF patient portal. One of the functions of the portal is to allow patients to enter specific data elements that become part of their permanent medical record. Diabetics can enter and review their home glucometer readings, and view alert messages based on their entries. The entries are transferred to the patient's primary care physician's EMR In-Basket for review.
We recognize that some patients will be more predisposed to technology adoption and some will be more health behavior compliant than others. Therefore, in addition to studying our portal's efficacy in positive diabetic behavior change, we will test if interventions can assist less predisposed and less compliant patients to become more compliant and more inclined to adopt the technology.
The goals of the proposed study are:
- to assess whether a web portal will improve care outcomes in diabetic patients; 2a) to describe the characteristics of patients whose health behavior improves over the study period; 2b) to describe the characteristics of patients who adopt the web portal-based disease management technology; 3) to develop and test targeted interventions to increase the adoption of the web portal and improve patient health behavior; 4) to monitor the ongoing costs associated with the web portal and patient healthcare resource utilization, and to monitor the incremental costs of the interventions designed to improve utilization of the technology and patient compliance with their diabetic regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Patient diabetic self-management using the diabetic patient portal tools | Behavioural | – |
| A variety of educational interventions for non-adopters of the technology, and for non-compliant patients. | Behavioural | – |
Primary outcome
Clinical Outcome Measures: HbA1c, LDL,and the presence or absence of clinically significant proteinuria.
1 secondary outcome
Technology Adoption will be measured by tracking the patient usage of the various portal features
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 27 Jul 2011.
- BackgroundAjzen, I. (1991). The Theory of Planned Behavior. Organizational Behavior and Human Decision Processes, Vol. 50: 179-211.
- BackgroundAvital, M., Vandenbosch, B., (2000) IT-Business Ownership: The Missing Link for IT-Driven Value, Administrative Sciences Association of Canada - 2000 Proceedings (Information Systems), Vol. 21(4): 116-125.
- Background: PubMed 12610059Hogan P, Dall T, Nikolov P; American Diabetes Association. Economic costs of diabetes in the US in 2002. Diabetes Care. 2003 Mar;26(3):917-32. doi: 10.2337/diacare.26.3.917.
- Background: PubMed 9727887Beckles GL, Engelgau MM, Narayan KM, Herman WH, Aubert RE, Williamson DF. Population-based assessment of the level of care among adults with diabetes in the U.S. Diabetes Care. 1998 Sep;21(9):1432-8. doi: 10.2337/diacare.21.9.1432.
- Background: PubMed 11187566Biermann E, Dietrich W, Standl E. Telecare of diabetic patients with intensified insulin therapy. A randomized clinical trial. Stud Health Technol Inform. 2000;77:327-32.
- BackgroundChang S., Ryoo S., Yu S., Ahn B., (1999) Development of an Internet-Based Home Monitoring System for Diabetes Mellitus, Proceeding of the 4th IEEE Malaysia International Conference on Communications and 4th IEEE Asia Pacific International Symposium on Consumer Electronics, Maleka, Malaysia, November 1999.
- Background: PubMed 12716807Chase HP, Pearson JA, Wightman C, Roberts MD, Oderberg AD, Garg SK. Modem transmission of glucose values reduces the costs and need for clinic visits. Diabetes Care. 2003 May;26(5):1475-9. doi: 10.2337/diacare.26.5.1475.
- Background: PubMed 10573279Eisenberg JM. Ten lessons for evidence-based technology assessment. JAMA. 1999 Nov 17;282(19):1865-9. doi: 10.1001/jama.282.19.1865. No abstract available.
- BackgroundFishbein M., Ajzen I., (1975) Belief, Attitude, Intention and Behavior: An Introduction to Theory and Research. Reading, MA: Addison-Wesley.
- Background: PubMed 9391929Friedman RH, Stollerman JE, Mahoney DM, Rozenblyum L. The virtual visit: using telecommunications technology to take care of patients. J Am Med Inform Assoc. 1997 Nov-Dec;4(6):413-25. doi: 10.1136/jamia.1997.0040413.
- Background: PubMed 10384677Friedman RH, Stollerman J, Rozenblyum L, Belfer D, Selim A, Mahoney D, Steinbach S. A telecommunications system to manage patients with chronic disease. Stud Health Technol Inform. 1998;52 Pt 2:1330-4.
- BackgroundGallagher, K., Vandenbosch, B., (2000) A Systemic View of Continual Change. Best Paper Proceedings of the Sixtieth Annual Meeting of the Academy of Management, August 2000.
- Patient portal log in pageLink provided by the sponsor.
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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.
Martin Harris, MD, MBA principal investigator
The Cleveland Clinic
Holly D Miller, MD, MBA study director
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Patient diabetic self-management using the diabetic patient portal tools and A variety of educational interventions for non-adopters of the technology, and for non-compliant patients. in people with Diabetes Mellitus, run by Robert Wood Johnson Foundation 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?
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 27 Jul 2011. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Clinical Outcome Measures: HbA1c, LDL,and the presence or absence of clinically significant proteinuria.. 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 NCT00221455, which also lists 33 linked publications.
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 27 Jul 2011.