Adolescents With Type 2 DiabetesNCT00889785
Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing a Randomized Controlled Trial (RCT)
A study testing Comprehensive intervention (disease management program) in people with Adolescents With Type 2 Diabetes, run by Vanderbilt University at 1 site in United States.
Trial summary
The proposed research will test a new comprehensive disease management intervention with adolescents who have type 2 diabetes using a randomized controlled trial (RCT). Adolescents subjects with a history of Type 2 Diabetes and a parent caregiver will be consented, enrolled, and randomly assigned to either an 6-month… Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Adolescents With Type 2 Diabetes
- What is being tested?
- Comprehensive intervention (disease management program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Aug 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with a diagnosis of T2DM will be included if they are:
- Age 12-19 years
- A clinical diagnosis of T2DM (according to the patient and their health provider in the clinic)
- Actively receive diabetes care in the Eskind Diabetes Clinic
- Willingness of patient and a caregiver to access the Internet to complete problem solving activities
- Adolescent address is the same as their primary caregiver participating in the study
Who cannot join
- Patients will be excluded if they meet any of the following:
- Identify an outside practitioner as the main provider of their diabetes care
- Have a significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study
- Life expectancy of <6 months
- Unable to access the Internet from any convenient location
- Blind or deaf
Show all 18Show fewer
- Parent Inclusion criteria:
- Parents must be a primary caregiver of an adolescent with a diagnosis of T2DM between the ages 12-19 seen at the Eskind Clinic
- Willingness of patient and a caregiver to access the Internet to complete problem solving activities.
- Parent Exclusion criteria:
- Patients will be excluded if they meet any of the following:
- Identify an outside practitioner as the main provider of their child's diabetes care
- Self report of significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study
- life expectancy of <6 months
- unable to access the Internet from any convenient location
- blind or deaf.
- Joint Inclusion criteria:
- Both the primary caregiver (parent) and adolescent must agree to participate in the research.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Univ Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing an RCT
The proposed research will test a new comprehensive disease management intervention with adolescents who have type 2 diabetes using a randomized controlled trial (RCT). Adolescents subjects with a history of Type 2 Diabetes and a parent caregiver will be consented, enrolled, and randomly assigned to either an 6-month intervention (N=44) or a "usual care" comparison (N=44). Recruitment will take place within the Vanderbilt Eskind Pediatric Diabetes Clinic. The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component. Outcomes include self-reported self-management behaviors (exercise, diet, medication adherence, etc.), blood pressure, weight/BMI, and glycated hemoglobin (A1C).
- Conditions
- Adolescents With Type 2 Diabetes
- Being tested
- Comprehensive intervention (disease management program), Usual Care
- Keywords
- Adolescents, Type 2 Diabetes, Behavioral Research
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive intervention (disease management program)Behavioural
The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component.
Usual CareBehavioural
Will receive usual care and monthly phone calls as an active control.
| Study group | Role | What they receive |
|---|---|---|
| 1 (Usual Care) | Active comparator | Patients will continue to review usual care in the diabetes clinic. Patients will receive monthly phone calls as an active control condition. Receives: Behavioral: Usual Care |
| Intervention | Experimental | The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component. Receives: Behavioral: Comprehensive intervention (disease management program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1C
Measured: 0,3,6 months
Lipids
Measured: 0,3,6 months
Secondary outcomes (2)
blood pressure
Measured: 0,3,6 months
self-care behaviors
Measured: 0,3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescents With Type 2 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Russell Rothman, Vanderbilt University
- Investigators
- Russell L Rothman, MD MPP, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889785
- Sponsor's protocol ID
- 090076
- Other IDs
- K23DK065294, R03DK081726
- Status last verified
- Dec 2013
- First submitted
- 28 Apr 2009
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Situational Problem Solving in Adolescents With Type 2 Diabetes: Enhancing an RCT
- ClinicalTrials.gov ID
- NCT00889785
- Acronym / sponsor ID
- 090076
- Conditions
- Adolescents With Type 2 Diabetes
- Keywords
- Adolescents, Type 2 Diabetes, Behavioral Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Apr 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.
The proposed research will test a new comprehensive disease management intervention with adolescents who have type 2 diabetes using a randomized controlled trial (RCT). Adolescents subjects with a history of Type 2 Diabetes and a parent caregiver will be consented, enrolled, and randomly assigned to either an 6-month intervention (N=44) or a "usual care" comparison (N=44). Recruitment will take place within the Vanderbilt Eskind Pediatric Diabetes Clinic. The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component. Outcomes include self-reported self-management behaviors (exercise, diet, medication adherence, etc.), blood pressure, weight/BMI, and glycated hemoglobin (A1C).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 (Usual Care) | Active comparator | Behavioral: Usual CarePatients will continue to review usual care in the diabetes clinic. Patients will receive monthly phone calls as an active control condition. |
| Intervention | Experimental | Behavioral: Comprehensive intervention (disease management program)The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 12-19 years
- A clinical diagnosis of T2DM (according to the patient and their health provider in the clinic)
- Actively receive diabetes care in the Eskind Diabetes Clinic
- Willingness of patient and a caregiver to access the Internet to complete problem solving activities
- Adolescent address is the same as their primary caregiver participating in the study
Key exclusion criteria (18 listed)
- Identify an outside practitioner as the main provider of their diabetes care
- Have a significant psychiatric illness such as severe depression or active psychosis that would impact on the ability to participate in the study
- Life expectancy of <6 months
- Unable to access the Internet from any convenient location
- Blind or deaf
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 |
|---|---|---|
| Comprehensive intervention (disease management program)The intervention will include participation in a comprehensive disease management program that includes: (1) application of treatment algorithms, (2) phone assessment from a diabetes nurse practitioner and dietician to assess barriers and promote problem solving, treatment adherence and management, and (3) a behavioral Internet-administered self-management problem solving component. | Behavioural | Intervention |
| Usual CareWill receive usual care and monthly phone calls as an active control. | Behavioural | 1 (Usual Care) |
Primary outcome
A1C
Time frame: 0,3,6 months
Lipids
Time frame: 0,3,6 months
2 secondary outcomes
blood pressure
Time frame: 0,3,6 months
self-care behaviors
Time frame: 0,3,6 months
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 18 Dec 2013.
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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.
Russell L Rothman, MD MPP principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive intervention (disease management program) in people with Adolescents With Type 2 Diabetes, run by Vanderbilt University 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 6 inclusion and 18 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 18 Dec 2013. 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?
A1C (time frame: 0,3,6 months). The study lists 2 primary outcomes in all. 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 18 Dec 2013.