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| ID | Type | Description | Link |
|---|---|---|---|
| 1DP3HD076602-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The overall goal of this project is to develop a novel family friendly intervention that will help teens with poor metabolic control of their type 1 diabetes increase and sustain daily self monitoring of blood glucose and lower HbA1c. This is important because poor metabolic control has long-term health implications. This project will provide important information regarding new effective ways to improve outcomes among teens with poorly controlled type 1 diabetes.
Primary hypotheses are that the intervention, MAxIM, will: (1) help teens improve and maintain glucose control, and (2) improve decision making (improve executive function and reduce delay discounting), which will predict treatment outcome.
Type 1 diabetes in adolescents is a significant medical condition associated with high economic costs and increased mortality, and its incidence is increasing. Unfortunately, adolescents show poorer adherence to self monitoring of blood glucose (SMBG) recommendations and poorer metabolic control than adults. Although some individual and family-based interventions have shown promise in improving metabolic control, there is a critical need to develop more effective interventions. The overall goal of this DP3 project is to develop a new innovative intervention that targets decision making to help teens with poor diabetic metabolic control increase the frequency of SMBG and improve HbA1c. The target population will be teens aged 13-17 with type 1 diabetes and HbA1c >8%. Based on our prior work and a conceptual model, the proposed study will develop and pilot test a novel, multifaceted, developmentally appropriate intervention aimed at improving adolescent decision making. An integrated set of components target adolescents' need for frequent positive feedback, improved future orientation, and motivational support. While past research indicates that behavioral interventions are frequently more successful when they include multiple elements, no previous intervention has combined multiple empirically-based components that target key decision making levers in one intervention. This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), an efficacious method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet to increase the reach of the intervention to families living distant from their treating endocrinologist. MAxIM will be teen and parent friendly and designed to increase engagement and compliance with the intervention. Primary hypotheses are that MAxIM will: (1) help teens improve and maintain glucose control, and (2) improve decision making (improve executive function and reduce delay discounting), which will predict treatment outcome. The unique set of interventions holds promise for improving adherence by affecting multiple basic mechanisms that determine poor decision making. The project will develop a novel, highly transportable, home based intervention designed to maximize and sustain HbA1c reductions and SMBG frequency over time in adolescents. Innovations include the targeting of multiple levers specific to adolescent decision making, use of technology to deliver the intervention to families at home, and testing cognitive predictors of treatment outcome for teens with diabetes. Successful achievement of this study's aims will bring the field closer to a cost effective, long-lasting intervention to improve outcomes among these high-risk youth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAxIM | Experimental | This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet. |
|
| Usual Care | Active Comparator | Usual Care reflects the standard treatment currently provided at the Children's Hospital at Dartmouth. Teens will be followed by their treating endocrinologist and receive the following standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAxIM | Behavioral | This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c at 12 Months | Glycated hemoglobin test (HbA1c) measures the non-enzymatic glycation status of hemoglobin expressed in percentage points. Analyses control for pump status, diabetes duration and baseline HbA1c | 12 months following enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment | Participants will use a glucometer to self-monitor blood glucose daily. Readings from the glucometer will be uploaded at each session and at the follow up visits. The glucometer records the blood glucose level as well as a date/time stamp over a 90 day period. To assess the daily testing frequency, the total number of blood glucose tests a day during the 14 days prior to each assessment will be recorded from the study provided glucometer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Stanger, PhD | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth College | Hanover | New Hampshire | 03755 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32508201 | Derived | Crochiere RJ, Hughes Lansing A, Carracher A, Vaid E, Stanger C. Attentional bias to diabetes cues mediates disease management improvements in a pilot randomized controlled trial for adolescents with type 1 diabetes. J Health Psychol. 2021 Dec;26(14):2699-2710. doi: 10.1177/1359105320926535. Epub 2020 Jun 7. | |
| 30418521 | Derived | Stanger C, Lansing AH, Scherer E, Budney A, Christiano AS, Casella SJ. A Web-Delivered Multicomponent Intervention for Adolescents with Poorly Controlled Type 1 Diabetes: A Pilot Randomized Controlled Trial. Ann Behav Med. 2018 Nov 12;52(12):1010-1022. doi: 10.1093/abm/kay005. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MAxIM | This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet. |
| FG001 | Usual Care | Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MAxIM | This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1c at 12 Months | Glycated hemoglobin test (HbA1c) measures the non-enzymatic glycation status of hemoglobin expressed in percentage points. Analyses control for pump status, diabetes duration and baseline HbA1c | Posted | Least Squares Mean | Standard Error | percentage glycated hemoglobin | 12 months following enrollment |
|
12 months
Adverse events were collected at each assessment through 12 months via the Health Services Utilization form (Huang, E. S., O'Grady, M., Basu, A., Winn, A., John, P., Lee, J., ... & Wysocki, T. (2010). The cost-effectiveness of continuous glucose monitoring in type 1 diabetes. Diabetes care, 33(6), 1269-1274.)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MAxIM | This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER visit with or without hospitalization for low blood sugar | Endocrine disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe low blood sugar event requiring assistance to treat | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine Stanger | Dartmouth-Hitchcock | 603-646-7023 | catherine.stanger@dartmouth.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Usual Care | Behavioral | Usual Care reflects the standard treatment currently provided at the Children's Hospital at Dartmouth. Teens will be followed by their treating endocrinologist and receive the following standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits. |
|
| 12 months following enrollment |
| BG001 | Usual Care | Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HbA1c | Mean | Standard Deviation | percentage glycated hemoglobin |
|
| OG001 | Usual Care | Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits. |
|
|
| Secondary | Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment | Participants will use a glucometer to self-monitor blood glucose daily. Readings from the glucometer will be uploaded at each session and at the follow up visits. The glucometer records the blood glucose level as well as a date/time stamp over a 90 day period. To assess the daily testing frequency, the total number of blood glucose tests a day during the 14 days prior to each assessment will be recorded from the study provided glucometer. | 1 participant in the MaxIM arm and 1 participant in the Usual Care arm did not provide meter data at 12 months so do not have data for this outcome. | Posted | Least Squares Mean | Standard Error | readings per day | 12 months following enrollment |
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| 1 |
| 30 |
| EG001 | Usual Care | Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits. | 0 | 31 | 3 | 31 | 1 | 31 |
| ER visit with or without hospitalization for high blood sugar | Endocrine disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |