Diabetes Mellitus, Type 2NCT00072891
Improving Medication Adherence in Comorbid Conditions
A study testing telephone counseling in people with Diabetes Mellitus, Type 2 and Hypertension, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This study is designed to study how adults with Type 2 Diabetes and either high blood pressure and/or high blood cholesterol manage their treatment regimen. It is also called the Diabetes Management Study. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension, Hyperlipidemia
- What is being tested?
- telephone counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2005
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Type 2 diabetes mellitus, hypertension and/or hyperlipidemia,
- On oral medication for two of the above conditions,
- Manage own medications,
- Must have access to a telephone,
- Not participating in other adherence education or counseling trials
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, 15261
About this study
This study is designed to study how adults with Type 2 Diabetes and either high blood pressure and/or high blood cholesterol manage their treatment regimen. It is also called the Diabetes Management Study. Individuals need to be 40 years of age or older and on oral medication (pills) management for two of the three conditions of interest. They may also be on other treatment such as insulin, diet and/or exercise programs. Individuals will be followed for approximately 12 months. About 1/4 of the persons in the study will receive a telephone counseling program with a nurse focused upon their management of their treatment program.
- Conditions
- Diabetes Mellitus, Type 2, Hypertension, Hyperlipidemia
- Being tested
- telephone counseling
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Hyperlipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone counselingBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2003 (estimated)
- Study completionDec 2005
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.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072891
- Sponsor's protocol ID
- 59048DK (completed)
- Status last verified
- Feb 2010
- First submitted
- 12 Nov 2003
- Last updated
- 15 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence in Comorbid Conditions
- ClinicalTrials.gov ID
- NCT00072891
- Acronym / sponsor ID
- 59048DK (completed)
- Conditions
- Diabetes Mellitus, Type 2, Hypertension, Hyperlipidemia
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study completion
- Dec 2005 (actual)
- First posted
- 14 Nov 2003 (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 designed to study how adults with Type 2 Diabetes and either high blood pressure and/or high blood cholesterol manage their treatment regimen. It is also called the Diabetes Management Study. Individuals need to be 40 years of age or older and on oral medication (pills) management for two of the three conditions of interest. They may also be on other treatment such as insulin, diet and/or exercise programs. Individuals will be followed for approximately 12 months. About 1/4 of the persons in the study will receive a telephone counseling program with a nurse focused upon their management of their treatment program.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 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 |
|---|---|---|
| telephone counseling | Behavioural | – |
Primary outcome
Not reported in the source record.
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 15 Feb 2010.
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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 telephone counseling in people with Diabetes Mellitus, Type 2 and Hypertension, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 15 Feb 2010. 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.
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 15 Feb 2010.