Diabetes Mellitus, Type 2NCT01051245
Effectiveness of a High-risk Diabetic Patients Program
A study testing Case manager counseling in people with Diabetes Mellitus, Type 2, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The purpose of this study is to determine whether case management for type 2 diabetic patients with target-organ damage improves quality of care compared to usual care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Case manager counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 1 siteArgentina
- Study dates
- Mar 2010to Mar 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diabetes mellitus
- Age between 18 and 80 years old
- Target organ damage (either macrovascular or microvascular)
- Patient's acceptance to participate
Who cannot join
- Moderate to severe dementia
- Life expectancy lower than one year
- Justified negative from primary care physician to intervene the patient.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether case management for type 2 diabetic patients with target-organ damage improves quality of care compared to usual care.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Case manager counseling, Usual care
- Keywords
- Diabetes Mellitus, Type 2 [C18.452.394.750.149], Case Management [N04.590.233.624.250], Disease Management [N04.590.607], Diabetes Complications [C19.246.099]
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case manager counselingBehavioural
Patients followed-up by case manager. Interventions based on the Chronic Care Model. Interventions are self management education, motivational interviewing, individualized counseling on non-pharmacological treatment to modify and sustain healthy lifestyle behaviours, and follow-up. Close contact with primary care physician and/or specialist by case manager, if clinical targets out of recommended standards. Pharmacological treatment not suggested, managed by personal criteria of health care professionals. Focus on targets.
Usual careOther
Usual care provided by primary care physician and/or specialist according to patients' needs and professional criteria. Includes free access to educational diabetes workshops and educational brochures.
| Study group | Role | What they receive |
|---|---|---|
| Case management | Active comparator | Patients followed-up by case manager. Interventions based on the Chronic Care Model. Interventions are self management education, motivational interviewing, individualized counseling on non-pharmacological treatment to modify and sustain healthy lifestyle behaviours, and follow-up. Close contact with primary care physician and/or specialist by case manager, if clinical targets out of recommended standards. Pharmacological treatment not suggested, managed by personal criteria of health care professionals. Focus on targets. Receives: Behavioral: Case manager counseling |
| Usual care group | Placebo comparator | Usual care provided by primary care physician and/or specialist. Free access to diabetes educational workshops. Regular delivery of educational brochures (not personally targeted). Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin
Measured: Two years
Secondary outcomes (1)
Quality of care process measures
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaston Perman, Hospital Italiano de Buenos Aires
- Investigators
- Gastón Perman, MD, MSc, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051245
- Sponsor's protocol ID
- 1494
- Status last verified
- Feb 2024
- First submitted
- 15 Jan 2010
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a High-risk Diabetic Patients Program
- ClinicalTrials.gov ID
- NCT01051245
- Acronym / sponsor ID
- 1494
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2 [C18.452.394.750.149], Case Management [N04.590.233.624.250], Disease Management [N04.590.607], Diabetes Complications [C19.246.099]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Jan 2010 (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.
The purpose of this study is to determine whether case management for type 2 diabetic patients with target-organ damage improves quality of care compared to usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case management | Active comparator | Behavioral: Case manager counselingPatients followed-up by case manager. Interventions based on the Chronic Care Model. Interventions are self management education, motivational interviewing, individualized counseling on non-pharmacological treatment to modify and sustain healthy lifestyle behaviours, and follow-up. Close contact with primary care physician and/or specialist by case manager, if clinical targets out of recommended standards. Pharmacological treatment not suggested, managed by personal criteria of health care professionals. Focus on targets. |
| Usual care group | Placebo comparator | Other: Usual careUsual care provided by primary care physician and/or specialist. Free access to diabetes educational workshops. Regular delivery of educational brochures (not personally targeted). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with diabetes mellitus
- Age between 18 and 80 years old
- Target organ damage (either macrovascular or microvascular)
- Patient's acceptance to participate
Key exclusion criteria (3 listed)
- Moderate to severe dementia
- Life expectancy lower than one year
- Justified negative from primary care physician to intervene the patient.
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 manager counselingPatients followed-up by case manager. Interventions based on the Chronic Care Model. Interventions are self management education, motivational interviewing, individualized counseling on non-pharmacological treatment to modify and sustain healthy lifestyle behaviours, and follow-up. Close contact with primary care physician and/or specialist by case manager, if clinical targets out of recommended standards. Pharmacological treatment not suggested, managed by personal criteria of health care professionals. Focus on targets. | Behavioural | Case management |
| Usual careUsual care provided by primary care physician and/or specialist according to patients' needs and professional criteria. Includes free access to educational diabetes workshops and educational brochures. | Other | Usual care group |
Primary outcome
Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin
Time frame: Two years
1 secondary outcome
Quality of care process measures
Time frame: Two years
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 Feb 2024.
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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.
Gastón Perman, MD, MSc principal investigator
Hospital Italiano de Buenos Aires
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 manager counseling in people with Diabetes Mellitus, Type 2, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 3 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 Feb 2024. 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 Argentina. 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?
Combined outcome assessing adequate control of hypertension, LDL-cholesterol and glycated hemoglobin (time frame: Two years). 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 28 Feb 2024.