Type 1 DiabetesNCT02115555
Advancing Diabetes Management in Adolescents Using Health Information Technology
A study testing HIT-aided approach, Contracted conflict management system and HIT plus contracted conflict management in people with Type 1 Diabetes, run by Indiana University at 2 sites in United States.
Trial summary
The study will compare three treatment strategies to look at the best clinical outcomes. The investigator hypothesizes that the combined approach of a health information technology program plus a conflict-management contract will lead to the best outcomes. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- HIT-aided approach, Contracted conflict management system and HIT plus contracted conflict management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Jun 2016
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes diagnosed for at least 6 months
- At least one or more parent/guardian who agrees to participate
Who cannot join
- Other chronic diseases with the exception of well-controlled asthma or treated thyroid disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Riley Children's Specialties
Carmel, Indiana, 46032
Riley Children's Hospital
Indianapolis, Indiana, 46202
About this study
The study will compare three treatment strategies to look at the best clinical outcomes.
The investigator hypothesizes that the combined approach of a health information technology program plus a conflict-management contract will lead to the best outcomes.
Read the detailed description
This study will compare three strategies for enhancing adherence to diabetes care in our population. The study will look at which strategy results in the best short-term clinical outcomes for the population. Also, the study will look at patient satisfaction of contact with his/her health care team, quality of life, and family dynamics.
The three arms are:
- HIT (health information technology) aided approach
- Contracted conflict-management strategy
- Combination of the HIT-aided approach and the contracted conflict management strategy
- Conditions
- Type 1 Diabetes
- Being tested
- HIT-aided approach, Contracted conflict management system, HIT plus contracted conflict management
- Keywords
- type 1, diabetes, adolescents, heath information technology
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIT-aided approachBehavioural
Subjects randomized to this approach will be using the HIT-aided monitor.
Contracted conflict management systemBehavioural
Subjects randomized to this arm will be using the behavioral contracted conflict management system.
HIT plus contracted conflict managementBehavioural
Subjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system.
| Study group | Role | What they receive |
|---|---|---|
| HIT-aided approach | Experimental | Adolescents and their parents randomized to this arm will be oriented on a HIT system. The system transmits self monitoring blood glucose self monitoring blood glucose data to a secure web portal. The subject will receive messages from the HIT system on the meter based upon the Self Monitored Blood glucose tests. Receives: Behavioral: HIT-aided approach |
| Contracted conflict management system | Experimental | Adolescent-parent pairs will meet with a health educator to establish a behavioral contract that will set patient-centered self-management goals for the adolescent. Receives: Behavioral: Contracted conflict management system |
| HIT plus contracted conflict management | Experimental | Adolescents and their parents randomized to this arm will be oriented on a HIT system. The system transmits self monitoring blood glucose data to a secure web portal. The subject will receive messages from the HIT system on the meter based upon the tests. In addition, adolescent-parent pairs will meet with a health educator to establish a behavioral contract that will set patient-centered self-management goals for the adolescent. This arm combines arms 1 and 2. Receives: Behavioral: HIT plus contracted conflict management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control using HBA1C
Change in Glycemic Control
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (4)
Frequency of self monitoring blood glucose measurement
change in Self-monitoring blood glucose measurement
Measured: Baseline, 3 months, 6 months
Quality of Life
Change in Diabetes-specific quality of life measures will be measured by the Varney's Pediatric Quality of Life 3.0 Diabetes Module.
Measured: Baseline and 6 months
Family dynamics
Change in family dynamics measured by the Cornell Parent Behavior Description Scale and the Helping for Health Inventory.
Measured: Baseline and 6 months
Treatment Adherence Behaviors
Change in treatment adherence behaviors measured by the Self-Care Inventory with supplemental questions determined by the investigator.
Measured: Once per month for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamara S. Hannon, Indiana University
- Investigators
- Tamara Hannon, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115555
- Sponsor's protocol ID
- IRB-04, IRB00000219
- Status last verified
- Feb 2019
- First submitted
- 17 Mar 2014
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be shared via presentation and publications.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Diabetes Management in Adolescents Using Health Information Technology
- ClinicalTrials.gov ID
- NCT02115555
- Acronym / sponsor ID
- IRB-04, IRB00000219
- Conditions
- Type 1 Diabetes
- Keywords
- type 1, diabetes, adolescents, heath information technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Apr 2014 (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 study will compare three treatment strategies to look at the best clinical outcomes.
The investigator hypothesizes that the combined approach of a health information technology program plus a conflict-management contract will lead to the best outcomes.
Detailed description
This study will compare three strategies for enhancing adherence to diabetes care in our population. The study will look at which strategy results in the best short-term clinical outcomes for the population. Also, the study will look at patient satisfaction of contact with his/her health care team, quality of life, and family dynamics.
The three arms are:
- HIT (health information technology) aided approach
- Contracted conflict-management strategy
- Combination of the HIT-aided approach and the contracted conflict management strategy
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIT-aided approach | Experimental | Behavioral: HIT-aided approachAdolescents and their parents randomized to this arm will be oriented on a HIT system. The system transmits self monitoring blood glucose self monitoring blood glucose data to a secure web portal. The subject will receive messages from the HIT system on the meter based upon the Self Monitored Blood glucose tests. |
| Contracted conflict management system | Experimental | Behavioral: Contracted conflict management systemAdolescent-parent pairs will meet with a health educator to establish a behavioral contract that will set patient-centered self-management goals for the adolescent. |
| HIT plus contracted conflict management | Experimental | Behavioral: HIT plus contracted conflict managementAdolescents and their parents randomized to this arm will be oriented on a HIT system. The system transmits self monitoring blood glucose data to a secure web portal. The subject will receive messages from the HIT system on the meter based upon the tests. In addition, adolescent-parent pairs will meet with a health educator to establish a behavioral contract that will set patient-centered self-management goals for the adolescent. This arm combines arms 1 and 2. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Type 1 diabetes diagnosed for at least 6 months
- At least one or more parent/guardian who agrees to participate
Key exclusion criteria (1 listed)
- Other chronic diseases with the exception of well-controlled asthma or treated thyroid disease
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 |
|---|---|---|
| HIT-aided approachSubjects randomized to this approach will be using the HIT-aided monitor. | Behavioural | HIT-aided approach |
| Contracted conflict management systemSubjects randomized to this arm will be using the behavioral contracted conflict management system. | Behavioural | Contracted conflict management system |
| HIT plus contracted conflict managementSubjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system. | Behavioural | HIT plus contracted conflict management |
Primary outcome
Glycemic Control using HBA1C
Time frame: Baseline, 3 months, and 6 months
Change in Glycemic Control
4 secondary outcomes
Frequency of self monitoring blood glucose measurement
Time frame: Baseline, 3 months, 6 months
Quality of Life
Time frame: Baseline and 6 months
Family dynamics
Time frame: Baseline and 6 months
Treatment Adherence Behaviors
Time frame: Once per month for 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 20 Feb 2019.
- Individual participant dataSharing planned: No. Data will be shared via presentation and publications.
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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.
Tamara Hannon, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIT-aided approach, Contracted conflict management system and HIT plus contracted conflict management in people with Type 1 Diabetes, run by Indiana University at 2 sites 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 2 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 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Glycemic Control using HBA1C (time frame: Baseline, 3 months, and 6 months). 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 20 Feb 2019.