DiabetesPhase 1NCT00242645
Computer-Assisted Cancer Risk Behavior Counseling
A Phase 1 study testing Health Information, Preventive Services and Computer tailored information in people with Diabetes and Diabetes Mellitus, run by Thomas Jefferson University.
Trial summary
To test whether or not giving patients information before their doctor visits changes the care they receive and what type of information is best to give before the doctor visit. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Hypertension
- What is being tested?
- Health Information, Preventive Services and Computer tailored information
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jun 2007
- Phase
- Phase 1
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- Has type 2 (adult-onset) diabetes;
- Developed diabetes after the age of 21;
- Has a scheduled doctor visit about diabetes in the next few months
Who cannot join
None listed.
About this study
To test whether or not giving patients information before their doctor visits changes the care they receive and what type of information is best to give before the doctor visit.
Read the detailed description
Patients are randomized into one of three groups. Before a single visit with diabetes care provider, the patient is called to answer interview questions about their health, diabetic care and behavior habits. After a patient visits with their doctor, they are called again to answer question about the visit they just had. If a patient is place into group A or B, based on their answers to the questions they are mailed a printed report before their doctor visit. The report will indicate how things are going the patient's diabetic care and recommended questions to ask his/her health care provided about diabetes. Group A feedback report will emphasize the risks from diabetes and the feedback reports for Group B will emphasize things to do to protect oneself from problems from having diabetes. Participants randomized to Group C will only receive printed reports after a doctors visit. No extra visit will be scheduled with the participants doctor, no travel is required, no blood tests are required and ther doctor will not be involved in the study unless the study participant chooses to discuss it with his/her doctor.
- Conditions
- Diabetes, Diabetes Mellitus, Hypertension
- Being tested
- Health Information, Preventive Services, Computer tailored information
- Keywords
- Doctor-Patient relation, Physician-Patient relation, Diabetes, Office visits, Comparative Study, Health behavior, Randomized controlled trials, Health Promotion, Health Education, Computer-tailor information
- Medical subject headings
- Diabetes Mellitus, Hypertension, Health Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health InformationBehavioural
Preventive ServicesBehavioural
Computer tailored informationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the effect of receiving computer tailored information about diabetes care before doctor visits and the differential effect of varying types of information
Secondary outcomes (1)
Patient exit interviews after doctor visits about what happened during the visits, such as what was discussed, what tests and consults were ordered and what medications were added or changed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2007
- Study completionJun 2007
Why it stopped: Administratively terminated.
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Christopher N Sciamanna, MD, Study chair, Thomas Jefferson Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242645
- Sponsor's protocol ID
- 04F.244
- Other IDs
- K07-CA91976-0, K07CA091976
- Status last verified
- Aug 2010
- First submitted
- 19 Oct 2005
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Cancer Risk Behavior Counseling
- ClinicalTrials.gov ID
- NCT00242645
- Acronym / sponsor ID
- 04F.244
- Conditions
- Diabetes, Diabetes Mellitus, Hypertension
- Keywords
- Doctor-Patient relation, Physician-Patient relation, Diabetes, Office visits, Comparative Study, Health behavior, Randomized controlled trials, Health Promotion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively terminated.
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 20 Oct 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.
To test whether or not giving patients information before their doctor visits changes the care they receive and what type of information is best to give before the doctor visit.
Detailed description
Patients are randomized into one of three groups. Before a single visit with diabetes care provider, the patient is called to answer interview questions about their health, diabetic care and behavior habits. After a patient visits with their doctor, they are called again to answer question about the visit they just had. If a patient is place into group A or B, based on their answers to the questions they are mailed a printed report before their doctor visit. The report will indicate how things are going the patient's diabetic care and recommended questions to ask his/her health care provided about diabetes. Group A feedback report will emphasize the risks from diabetes and the feedback reports for Group B will emphasize things to do to protect oneself from problems from having diabetes. Participants randomized to Group C will only receive printed reports after a doctors visit. No extra visit will be scheduled with the participants doctor, no travel is required, no blood tests are required and ther doctor will not be involved in the study unless the study participant chooses to discuss it with his/her doctor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older;
- Has type 2 (adult-onset) diabetes;
- Developed diabetes after the age of 21;
- Has a scheduled doctor visit about diabetes in the next few months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Health Information | Behavioural | – |
| Preventive Services | Behavioural | – |
| Computer tailored information | Behavioural | – |
Primary outcome
To test the effect of receiving computer tailored information about diabetes care before doctor visits and the differential effect of varying types of information
1 secondary outcome
Patient exit interviews after doctor visits about what happened during the visits, such as what was discussed, what tests and consults were ordered and what medications were added or changed.
Results and safety
The study was stopped early (reason given: Administratively terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 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.
Christopher N Sciamanna, MD study chair
Thomas Jefferson Unversity
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Health Information, Preventive Services and Computer tailored information in people with Diabetes and Diabetes Mellitus, run by Thomas Jefferson University.
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 0 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: stopped early, as of the sponsor's last update on 25 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administratively terminated.). Results are not available in the source record.
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?
To test the effect of receiving computer tailored information about diabetes care before doctor visits and the differential effect of varying types of information. 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 25 Aug 2010; AzTrials last refreshed its copy on 30 Oct 2026.