DiabetesNCT00223340
The ABC Planning Study: Diabetes and Cardiovascular Risks in Primary Care
A study testing Patient Activation and Diabetes Registry in people with Diabetes, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The purpose of this pilot study is to collect preliminary information about the best way to implement an intervention to reduce the risks of heart disease and stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Patient Activation and Diabetes Registry
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jun 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient must be diagnosed with diabetes for at least 12 months.
- Patient must be with current physician for at least 12 months.
- Study staff must be able to reach patient by telephone.
Who cannot join
- Pregnant women are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio (Texas)
San Antonio, Texas, 78229
About this study
Official title: Diabetes and Cardiovascular Risks in Primary Care
The purpose of this pilot study is to collect preliminary information about the best way to implement an intervention to reduce the risks of heart disease and stroke.
Read the detailed description
This study has two types of interventions. The clinics and patients are randomly assigned to either a control or intervention group. All clinics have both control and intervention patients. In the clinic intervention, we help doctors monitor patient information about the risk factors of heart disease and stroke. In the patient intervention, we contact patients by phone to discuss these risk factors before their doctor visits.
- Conditions
- Diabetes
- Being tested
- Patient Activation and Diabetes Registry
- Keywords
- patient activation, primary care, diabetes, cardiovascular risk
- 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 Activation and Diabetes RegistryBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke
Secondary outcomes (4)
Patient Outcome Measures: Hemoglobin A1c (HbA1c), lipids (low-density lipoprotein [LDL] non-high-density lipoprotein [HDL] triglycerides), blood pressure
Patient assessed health status, diabetes self-care activities and knowledge of cardiovascular (CV) risk factors
Physician Outcome Measures: Physician knowledge, attitude and readiness to change practice; Physician-level measure of patient-centeredness of encounter and interpersonal communication
Assessment of Chronic Illness Care (ACIC) Surveys
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 startMar 2005
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael L Parchman, MD, MPH, Principal investigator, Univ. of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223340
- Sponsor's protocol ID
- 1 R34 DK 067300-1A1 [NIDDK]
- Other IDs
- 1 R34 DK 067300-1A1 [NIDDK], 1R34DK067300
- Status last verified
- Jun 2012
- First submitted
- 13 Sep 2005
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes and Cardiovascular Risks in Primary Care
- ClinicalTrials.gov ID
- NCT00223340
- Acronym / sponsor ID
- 1 R34 DK 067300-1A1 [NIDDK]
- Conditions
- Diabetes
- Keywords
- patient activation, primary care, diabetes, cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007
- 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.
The purpose of this pilot study is to collect preliminary information about the best way to implement an intervention to reduce the risks of heart disease and stroke.
Detailed description
This study has two types of interventions. The clinics and patients are randomly assigned to either a control or intervention group. All clinics have both control and intervention patients. In the clinic intervention, we help doctors monitor patient information about the risk factors of heart disease and stroke. In the patient intervention, we contact patients by phone to discuss these risk factors before their doctor visits.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must be diagnosed with diabetes for at least 12 months.
- Patient must be with current physician for at least 12 months.
- Study staff must be able to reach patient by telephone.
Key exclusion criteria (1 listed)
- Pregnant women are excluded.
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 Activation and Diabetes Registry | Behavioural | – |
Primary outcome
Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke
4 secondary outcomes
Patient Outcome Measures: Hemoglobin A1c (HbA1c), lipids (low-density lipoprotein [LDL] non-high-density lipoprotein [HDL] triglycerides), blood pressure
Patient assessed health status, diabetes self-care activities and knowledge of cardiovascular (CV) risk factors
Physician Outcome Measures: Physician knowledge, attitude and readiness to change practice; Physician-level measure of patient-centeredness of encounter and interpersonal communication
Assessment of Chronic Illness Care (ACIC) Surveys
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 2 Jul 2012.
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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.
Michael L Parchman, MD, MPH principal investigator
Univ. of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Activation and Diabetes Registry in people with Diabetes, run by The University of Texas Health Science Center at San Antonio 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 3 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 2 Jul 2012. 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?
Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke. 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 2 Jul 2012.