Diabetes MellitusNCT00105898
Internet-based Diabetes Education and Case Management
A study testing Web-based care management, Telephone and face-to-face care management and Internet access alone in people with Diabetes Mellitus and Hypertension, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus. Read more about this study
- Who is it for?
- Ages 25 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Hypertension
- What is being tested?
- Web-based care management, Telephone and face-to-face care management and Internet access alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jun 2010
- 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 25 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus
- Age 25-79 years
- HbA1c >=8.5%
- Ability to speak and understand English
- Telephone access
- VA-based primary care provider
- Interest in using a glucose and BP monitor and notebook computer
Who cannot join
- Visual impairment that affects ability to read
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Brockton Campus, Brockton, MA
Brockton, Massachusetts, 02301
About this study
This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus.
Read the detailed description
Background:
Patients with diabetes and elevated hemoglobin A1c (HbA1c) are at risk for diabetes-related complications. Care-management may be helpful in these patients, by providing direct contact between such high-risk patients and the healthcare system. Web-based systems have previously shown promise as a means of neutralizing access barriers such as scheduling and travel to appointments and may be of particular help in improving diabetes care.
Objectives:
We examined the efficacy of two methods of diabetes education and care management: (1) a traditional model that involved telephone contact and face-to-face encounters (2) a web-based model with access to a diabetes care management web site. We compared these interventions to a study group that received no education or care management but was provided with a computer and access to diabetes self-management websites.
Methods:
This study employed a randomized, parallel group design involving patients with diabetes mellitus and an elevated HbA1c ( 8.5%). Participants assigned to web-based care management received a notebook computer, Internet access and interacted with a care manager through a diabetes education and care management website. Participants receiving telephone-based care management interacted with a care manager using telephone and face-to-face contact. Both care management models employed medication algorithms to improve glucose and BP control. These care management groups were compared to a study group that had no care management but received a notebook computer and Internet access with their "home page" containing links to a series of diabetes self-management websites (i.e. computer only group). The primary outcome measures were HbA1c, blood pressure, and scores on the Problem Areas in Diabetes (PAID) questionnaire, each measured over 12-months.
Status:
Complete
- Conditions
- Diabetes Mellitus, Hypertension
- Being tested
- Web-based care management, Telephone and face-to-face care management, Internet access alone
- Keywords
- Diabetes mellitus, Hypertension, Telemedicine, Case management
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based care managementProcedure or surgery
Participants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters
Telephone and face-to-face care managementProcedure or surgery
Participants interact with a care manager via face-to-face and telephone contact
Internet access aloneProcedure or surgery
Participants are given internet access and encouraged to seek diabetes information to help in their self management
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Intervention group Receives: Procedure: Web-based care management |
| Arm 2 | Active comparator | Comparator Receives: Procedure: Telephone and face-to-face care management |
| Arm 3 | Sham comparator | Comparator Receives: Procedure: Internet access alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c at 12 months
Measured: 12 months
Secondary outcomes (1)
Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2005 (estimated)
- Study startFeb 2005
- Primary completionApr 2007
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul R. Conlin, MD, Principal investigator, VA Boston Healthcare System Brockton Campus, Brockton, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105898
- Sponsor's protocol ID
- TEL 02-100
- Status last verified
- Aug 2010
- First submitted
- 17 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Conlin PR. Genes and environment in blood pressure control--salt intake again shows its importance. Am J Clin Nutr. 2008 Aug;88(2):255-6. doi: 10.1093/ajcn/88.2.255. No abstract available.
PubMed 18689358Kerfoot BP, Conlin PR, Travison T, McMahon GT. Patient safety knowledge and its determinants in medical trainees. J Gen Intern Med. 2007 Aug;22(8):1150-4. doi: 10.1007/s11606-007-0247-8. Epub 2007 Jun 6.
PubMed 17551796McMahon GT, Fonda SJ, Gomes HE, Alexis G, Conlin PR. A randomized comparison of online- and telephone-based care management with internet training alone in adult patients with poorly controlled type 2 diabetes. Diabetes Technol Ther. 2012 Nov;14(11):1060-7. doi: 10.1089/dia.2012.0137. Epub 2012 Sep 6.
PubMed 22953754
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Diabetes Education and Case Management
- ClinicalTrials.gov ID
- NCT00105898
- Acronym / sponsor ID
- TEL 02-100
- Conditions
- Diabetes Mellitus, Hypertension
- Keywords
- Diabetes mellitus, Hypertension, Telemedicine, Case management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 18 Mar 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.
This study is comparing the effectiveness of web-based care management to either telephone-based care management or internet access alone, in patients with poorly controlled diabetes mellitus.
Detailed description
Background:
Patients with diabetes and elevated hemoglobin A1c (HbA1c) are at risk for diabetes-related complications. Care-management may be helpful in these patients, by providing direct contact between such high-risk patients and the healthcare system. Web-based systems have previously shown promise as a means of neutralizing access barriers such as scheduling and travel to appointments and may be of particular help in improving diabetes care.
Objectives:
We examined the efficacy of two methods of diabetes education and care management: (1) a traditional model that involved telephone contact and face-to-face encounters (2) a web-based model with access to a diabetes care management web site. We compared these interventions to a study group that received no education or care management but was provided with a computer and access to diabetes self-management websites.
Methods:
This study employed a randomized, parallel group design involving patients with diabetes mellitus and an elevated HbA1c ( 8.5%). Participants assigned to web-based care management received a notebook computer, Internet access and interacted with a care manager through a diabetes education and care management website. Participants receiving telephone-based care management interacted with a care manager using telephone and face-to-face contact. Both care management models employed medication algorithms to improve glucose and BP control. These care management groups were compared to a study group that had no care management but received a notebook computer and Internet access with their "home page" containing links to a series of diabetes self-management websites (i.e. computer only group). The primary outcome measures were HbA1c, blood pressure, and scores on the Problem Areas in Diabetes (PAID) questionnaire, each measured over 12-months.
Status:
Complete
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Web-based care managementIntervention group |
| Arm 2 | Active comparator | Procedure: Telephone and face-to-face care managementComparator |
| Arm 3 | Sham comparator | Procedure: Internet access aloneComparator |
Who may qualify
- Ages
- 25 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of diabetes mellitus
- Age 25-79 years
- HbA1c >=8.5%
- Ability to speak and understand English
- Telephone access
Key exclusion criteria (1 listed)
- Visual impairment that affects ability to read
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 |
|---|---|---|
| Web-based care managementParticipants interact with a care manager, sending and receiving messages using an internet portal that accepts uploads from glucose and BP meters | Procedure or surgery | Arm 1 |
| Telephone and face-to-face care managementParticipants interact with a care manager via face-to-face and telephone contact | Procedure or surgery | Arm 2 |
| Internet access aloneParticipants are given internet access and encouraged to seek diabetes information to help in their self management | Procedure or surgery | Arm 3 |
Primary outcome
Change in HbA1c at 12 months
Time frame: 12 months
1 secondary outcome
Change in blood pressure, lipid profile and diabetes-related stress (self-report) at 12 months; cost-effectiveness analysis of the interventions.
Time frame: 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 7 Apr 2015.
- Results publication: PubMed 18689358Conlin PR. Genes and environment in blood pressure control--salt intake again shows its importance. Am J Clin Nutr. 2008 Aug;88(2):255-6. doi: 10.1093/ajcn/88.2.255. No abstract available.
- Results publication: PubMed 17551796Kerfoot BP, Conlin PR, Travison T, McMahon GT. Patient safety knowledge and its determinants in medical trainees. J Gen Intern Med. 2007 Aug;22(8):1150-4. doi: 10.1007/s11606-007-0247-8. Epub 2007 Jun 6.
- Derived from this study: PubMed 22953754McMahon GT, Fonda SJ, Gomes HE, Alexis G, Conlin PR. A randomized comparison of online- and telephone-based care management with internet training alone in adult patients with poorly controlled type 2 diabetes. Diabetes Technol Ther. 2012 Nov;14(11):1060-7. doi: 10.1089/dia.2012.0137. Epub 2012 Sep 6.
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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 R. Conlin, MD principal investigator
VA Boston Healthcare System Brockton Campus, Brockton, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based care management, Telephone and face-to-face care management and Internet access alone in people with Diabetes Mellitus and Hypertension, run by US Department of Veterans Affairs 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 7 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 7 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 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. Some participants in this study may receive a placebo. 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?
Change in HbA1c at 12 months (time frame: 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 NCT00105898, which also lists 3 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 7 Apr 2015.