Diabetes MellitusNCT00935441
Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes
A study testing case management with telemonitoring and usual case management in people with Diabetes Mellitus, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
This is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- case management with telemonitoring and usual case management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Sep 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled at Minneapolis VAMC,
- Type 1 or 2 Diabetes,
- HbA1c >8.5%,
- active land-line telephone connection
Who cannot join
- Age >75 years,
- primary care provider unwilling to have patient enrolled,
- active dialysis,
- resident of assisted living facility,
- research participant in previous diabetes case management study,
- life expectancy <1 year,
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- severe mental health condition,
- active substance abuse,
- pregnant or planning on becoming pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nurse-Based, Protocol-Driven, Case-Management Utilizing Home Telemonitoring and Home HbA1c Measurement on Diabetes and Blood Pressure Outcomes
This is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. We hypothesize that nurse case management, with home telemonitoring of blood sugars and home HbA1c measurement will result in additional improvements in glycemic control compared to isolated nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower compared to usual nurse case management. Secondary aims include an additional 5 mmHg improvement in systolic blood pressure (among patients with hypertension at the time of enrollment), improved patient satisfaction with treatment, improved medication adherence, reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for telephone communication. Patients will be enrolled and actively case managed for 9 months.
- Conditions
- Diabetes Mellitus
- Being tested
- case management with telemonitoring, usual case management
- Keywords
- Diabetes mellitus, chronic care, case management, telemedicine
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
case management with telemonitoringBehavioural
telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement
usual case managementBehavioural
telephone contact with a case manager
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | Case management with home telemonitoring for blood sugar and blood pressure plus home HbA1c measurement Receives: Behavioral: case management with telemonitoring |
| Usual case management | Active comparator | Case management Receives: Behavioral: usual case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control (HbA1c)
Measured: 9 months after enrollment
Secondary outcomes (1)
Systolic blood pressure control in patients with elevated blood pressure at baseline
Measured: 9 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Nacide Ercan-Fang, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935441
- Sponsor's protocol ID
- 4127-B
- Status last verified
- Sep 2011
- First submitted
- 8 Jul 2009
- Last updated
- 16 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nurse-Based, Protocol-Driven, Case-Management Utilizing Home Telemonitoring and Home HbA1c Measurement on Diabetes and Blood Pressure Outcomes
- ClinicalTrials.gov ID
- NCT00935441
- Acronym / sponsor ID
- 4127-B
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, chronic care, case management, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Study start
- Jun 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Jul 2009 (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 is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. We hypothesize that nurse case management, with home telemonitoring of blood sugars and home HbA1c measurement will result in additional improvements in glycemic control compared to isolated nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower compared to usual nurse case management. Secondary aims include an additional 5 mmHg improvement in systolic blood pressure (among patients with hypertension at the time of enrollment), improved patient satisfaction with treatment, improved medication adherence, reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for telephone communication. Patients will be enrolled and actively case managed for 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Behavioral: case management with telemonitoringCase management with home telemonitoring for blood sugar and blood pressure plus home HbA1c measurement |
| Usual case management | Active comparator | Behavioral: usual case managementCase management |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolled at Minneapolis VAMC,
- Type 1 or 2 Diabetes,
- HbA1c >8.5%,
- active land-line telephone connection
Key exclusion criteria (9 listed)
- Age >75 years,
- primary care provider unwilling to have patient enrolled,
- active dialysis,
- resident of assisted living facility,
- research participant in previous diabetes case management study,
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 |
|---|---|---|
| case management with telemonitoringtelephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement | Behavioural | Telemonitoring |
| usual case managementtelephone contact with a case manager | Behavioural | Usual case management |
Primary outcome
Glycemic control (HbA1c)
Time frame: 9 months after enrollment
1 secondary outcome
Systolic blood pressure control in patients with elevated blood pressure at baseline
Time frame: 9 months after enrollment
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 16 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing case management with telemonitoring and usual case management in people with Diabetes Mellitus, run by Minneapolis Veterans Affairs Medical Center 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 4 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 16 Sep 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.
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?
Glycemic control (HbA1c) (time frame: 9 months after enrollment). 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 16 Sep 2011.