Contingent Versus Noncontingent IncentivesNCT02638246
Incentives for Internet-based Adherence to SMBG for Teens With T1D
A study testing Internet-delivered, Incentive-based intervention + Motivational Interviewing and Internet-delivered, non-contingent incentives + Motivational Interviewing in people with Contingent Versus Noncontingent Incentives, run by Rowan University.
Trial summary
Self-management of diabetes can result in long-term benefits, such as delaying or preventing the development of a number of unnecessary health complications, and can even reduce the chances of premature death. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Contingent Versus Noncontingent Incentives
- What is being tested?
- Internet-delivered, Incentive-based intervention + Motivational Interviewing and Internet-delivered, non-contingent incentives + Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Dec 2012
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosed with Type 1 diabetes for at least one year
- Self-reported self-monitoring blood glucose less than four times per day
- Lived in a home with Internet access
- No travel plans within 2 months of enrolling in the study
- Read and spoke English
Who cannot join
- Diagnosis other Type 1 diabetes within one year of screening
- Not attending regular clinic appointment within 3 months of screening
About this study
Official title: Incentives for Internet-based Glucose Testing in Adolescent Type 1 Diabetes
Self-management of diabetes can result in long-term benefits, such as delaying or preventing the development of a number of unnecessary health complications, and can even reduce the chances of premature death. Because adherence to diabetes self-management often declines during adolescence, it is critically important to develop interventions that increase adherence of diabetes self-management skills in this population.
Read the detailed description
Intensive glycemic control among diabetics decreases the risk of both the development and progression of a number of medical complications associated with diabetes. Self-monitoring blood glucose is a critical component of diabetes self-management and is correlated with improvements in glycemic control. Nevertheless, adherence to blood glucose monitoring is generally poor, particularly among youth, with one study reporting that only ~ 25% of adolescents adhered to the recommended frequency of blood glucose testing.
The current study will use a powerful, scientifically-based behavioral intervention - contingency management (CM) to increase self-monitoring of blood glucose and improve glycemic control among adolescents with Type 1 diabetes. CM involves giving incentives for objective evidence of a target behavior and has been shown to have a robust and reliable impact in promoting behavior change. Our previous research used the Internet to objectively monitor smoking and reinforce smoking cessation (via video recorded carbon monoxide submissions), which resulted in robust increases in smoking abstinence. The current proposal extends this effective Internet-based CM intervention to address the significant health issue of non-adherence to blood glucose testing and glycemic control among youth. Two groups of non-adherent adolescents will be recruited. One group will earn incentives over the Internet for submitting webcam recorded videos that show them testing their blood glucose. A different group will be given standard care recommendations for blood glucose testing and management and will be encouraged to submit glucose monitoring videos, but incentives will not be delivered contingent on submissions (instead, they will earn monetary incentives independent of video submissions, but in an overall amount that matches the earnings of a participant in the other group). The purpose of the study is to evaluate the feasibility, convenience, and efficacy of using Internet-based CM to increase blood glucose monitoring in adolescent Type 1 diabetics.
Combining the accessibility of the Internet with a powerful, evidence-based behavioral intervention can have profound effects on adherence to diabetes self-management in this important population. Improving adherence to diabetes management in adolescents is a significant public health issue - serious medical complications, such as heart disease and nerve damage, that would develop with poor glycemic control can be avoided. Importantly, the current study offers a scientifically-based behavioral intervention that could be applied to a range of populations and behavior relevant to adherence with diabetes regimens (e.g., adults, medication adherence, carbohydrate counting, insulin dose adjustment, etc.).
- Being tested
- Internet-delivered, Incentive-based intervention + Motivational Interviewing, Internet-delivered, non-contingent incentives + Motivational Interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered, Incentive-based intervention + Motivational InterviewingBehavioural
Blood glucose monitoring was verified by videos uploaded to a secure server. Participants in the experimental group received incentives for adherence whereas participants in the control group received adherence independent of adherence.
Internet-delivered, non-contingent incentives + Motivational InterviewingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Contingent | Experimental | Participants in this group received incentives contingent on meeting pre-specified daily blood-glucose testing adherence goals. Receives: Behavioral: Internet-delivered, Incentive-based intervention + Motivational Interviewing |
| Noncontingent | Active comparator | Participants in this group received incentives independent of meeting pre-specified daily blood glucose testing adherence goals. Receives: Behavioral: Internet-delivered, non-contingent incentives + Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily frequency of self-monitoring blood glucose
Measured: 45 days
Percentage of days conducted at least 4 tests per day.
Measured: 45 days
Secondary outcomes (2)
Acceptability of the intervention
This was measured using a Treatment Acceptability Questionnaire
Measured: 45 days
Feasibility
Feasibility was based on willingness to participate (recruitment), adherence with the video submission protocol, and attrition
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contingent Versus Noncontingent IncentivesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Development and Research Institutes, Inc.
- Responsible party
- Sponsor
- Investigators
- Bethany Raiff, PhD, Principal investigator, Rowan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638246
- Sponsor's protocol ID
- R21HD061683-02
- Status last verified
- Dec 2015
- First submitted
- 17 Dec 2015
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Only upon request
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentives for Internet-based Glucose Testing in Adolescent Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02638246
- Acronym / sponsor ID
- R21HD061683-02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Collaborators
- National Development and Research Institutes, Inc.
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Dec 2015 (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.
Self-management of diabetes can result in long-term benefits, such as delaying or preventing the development of a number of unnecessary health complications, and can even reduce the chances of premature death. Because adherence to diabetes self-management often declines during adolescence, it is critically important to develop interventions that increase adherence of diabetes self-management skills in this population.
Detailed description
Intensive glycemic control among diabetics decreases the risk of both the development and progression of a number of medical complications associated with diabetes. Self-monitoring blood glucose is a critical component of diabetes self-management and is correlated with improvements in glycemic control. Nevertheless, adherence to blood glucose monitoring is generally poor, particularly among youth, with one study reporting that only ~ 25% of adolescents adhered to the recommended frequency of blood glucose testing.
The current study will use a powerful, scientifically-based behavioral intervention - contingency management (CM) to increase self-monitoring of blood glucose and improve glycemic control among adolescents with Type 1 diabetes. CM involves giving incentives for objective evidence of a target behavior and has been shown to have a robust and reliable impact in promoting behavior change. Our previous research used the Internet to objectively monitor smoking and reinforce smoking cessation (via video recorded carbon monoxide submissions), which resulted in robust increases in smoking abstinence. The current proposal extends this effective Internet-based CM intervention to address the significant health issue of non-adherence to blood glucose testing and glycemic control among youth. Two groups of non-adherent adolescents will be recruited. One group will earn incentives over the Internet for submitting webcam recorded videos that show them testing their blood glucose. A different group will be given standard care recommendations for blood glucose testing and management and will be encouraged to submit glucose monitoring videos, but incentives will not be delivered contingent on submissions (instead, they will earn monetary incentives independent of video submissions, but in an overall amount that matches the earnings of a participant in the other group). The purpose of the study is to evaluate the feasibility, convenience, and efficacy of using Internet-based CM to increase blood glucose monitoring in adolescent Type 1 diabetics.
Combining the accessibility of the Internet with a powerful, evidence-based behavioral intervention can have profound effects on adherence to diabetes self-management in this important population. Improving adherence to diabetes management in adolescents is a significant public health issue - serious medical complications, such as heart disease and nerve damage, that would develop with poor glycemic control can be avoided. Importantly, the current study offers a scientifically-based behavioral intervention that could be applied to a range of populations and behavior relevant to adherence with diabetes regimens (e.g., adults, medication adherence, carbohydrate counting, insulin dose adjustment, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingent | Experimental | Behavioral: Internet-delivered, Incentive-based intervention + Motivational InterviewingParticipants in this group received incentives contingent on meeting pre-specified daily blood-glucose testing adherence goals. |
| Noncontingent | Active comparator | Behavioral: Internet-delivered, non-contingent incentives + Motivational InterviewingParticipants in this group received incentives independent of meeting pre-specified daily blood glucose testing adherence goals. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with Type 1 diabetes for at least one year
- Self-reported self-monitoring blood glucose less than four times per day
- Lived in a home with Internet access
- No travel plans within 2 months of enrolling in the study
- Read and spoke English
Key exclusion criteria (2 listed)
- Diagnosis other Type 1 diabetes within one year of screening
- Not attending regular clinic appointment within 3 months of screening
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 |
|---|---|---|
| Internet-delivered, Incentive-based intervention + Motivational InterviewingBlood glucose monitoring was verified by videos uploaded to a secure server. Participants in the experimental group received incentives for adherence whereas participants in the control group received adherence independent of adherence. | Behavioural | Contingent |
| Internet-delivered, non-contingent incentives + Motivational Interviewing | Behavioural | Noncontingent |
Primary outcome
Daily frequency of self-monitoring blood glucose
Time frame: 45 days
Percentage of days conducted at least 4 tests per day.
Time frame: 45 days
2 secondary outcomes
Acceptability of the intervention
Time frame: 45 days
Feasibility
Time frame: 45 days
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 23 Dec 2015.
- Individual participant dataSharing planned: No. Only upon request
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.
Bethany Raiff, PhD principal investigator
Rowan University
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered, Incentive-based intervention + Motivational Interviewing and Internet-delivered, non-contingent incentives + Motivational Interviewing in people with Contingent Versus Noncontingent Incentives, run by Rowan 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 5 inclusion and 2 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 23 Dec 2015. 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.
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?
Daily frequency of self-monitoring blood glucose (time frame: 45 days). 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 23 Dec 2015; AzTrials last refreshed its copy on 2 Nov 2026.