Promoting Adolescent Investment In Diabetes Care

Study Overview
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Brief Summary
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Two financial incentive strategies targeting adolescents with type 1 diabetes will be compared to usual care for motivating adolescents to engage in improved self-care to manage their diabetes.

Detailed Description
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Participants will be asked to choose a self-care goal relevant to the device(s) they use to manage their diabetes from a pre-defined list of self-care targets. A randomized 3 (treatment) x 3 (occasion) crossover design will be used to compare treatments that are administered to participants in a predetermined sequence. The intervention arms include financial incentives administered in a gain- and loss-frame for adherence to daily self-care goals. The control arm is usual care. Participants can also earn additional incentives for meeting clinical care goals such as an improvement in the percentage of time glucose levels are consistent with hyperglycemia (>180 mg/dL). The primary outcome will be HbA1c at 12 weeks compared to baseline. Secondary outcomes will include frequency of insulin administration, engagement in diabetes self-care (SCI-R), patient-reported outcomes (Problem Areas in Diabetes - Teen version and Diabetes Family Conflict Scale).

Official Title
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Promoting Adolescent Investment In Diabetes Care

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Financial incentive (gain)
* Behavioral: Financial incentive (loss)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >12 and ≤18 years old Diagnosed with type 1 diabetes ≥12 months Speaks English fluently Cognitively able to participate in incentive program and complete surveys. Have access to a mobile phone to receive goal-obtainment and incentive updates Receives diabetes-related clinical care from Seattle Children's Hospital Diabetes Clinic Have the ability to upload medical data remotely from home per usual care processes employed by Seattle Children's Hospital Diabetes Clinics Exclusion Criteria: Patient is already participating in another research study to improve diabetes self-care and/or glycemic control Baseline daily average glucose checks are greater than 4 checks per day OR baseline daily CGM active wear is greater than 70% of the time AND baseline average insulin bolus score is greater than 3 times a day OR they do not use an insulin pump (or are unwilling to use a smart insulin pen) Patient refusal to participate (any age), or caregiver refusal to participate for patients less than 18 years of age Cognitively or physically unable to participate Patient is unable to speak in the English language Patient is unable to read in the English language Patient is a ward of the state Patient has severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care reflects the standard treatment currently provided to T1D patients. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. Telephone consultations are available 24/7 as often as necessary between clinic visits. | |
| Experimental: Gain-framed incentive<br>Participants will start off with nothing at the beginning of the treatment period. For each day that participants' meet goals, value will be added to their incentive balance. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. Telephone consultations are available 24/7 as often as necessary between clinic visits. | Behavioral: Financial incentive (gain)<br>* Participants will receive a daily financial incentive framed as a gain with money allocated each day of adherence to a self-care coal. Participants will receive an additional weekly incentive for meeting a clinical outcome goal.<br>|
| Experimental: Loss-framed incentive<br>Participants will start off at the maximum incentive balance at the beginning of the treatment period and for each day that participants' fail to meet goals, value will be subtracted from their incentive balance over the 12-week. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. Telephone consultations are available 24/7 as often as necessary between clinic visits. | Behavioral: Financial incentive (loss)<br>* Participants will receive a daily financial incentive framed as a loss with money allocated up front and taken away each day of non-adherence to a self-care coal. An additional weekly incentive will be deducted for failure to meet a clinical outcome goal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change in HbA1c from baseline to 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose monitoring | Frequency of glucose monitoring | 12 weeks | 
| Insulin Administration | Insulin pumps and smart insulin pens track administration of all insulin manually delivered by the participant | 12 weeks | 
| SCI-R | The Self Care Inventory Revised is a 14-item self-report measure of perceived adherence to diabetes self-care recommendations | 12 weeks | 
| PAID-T | Problem Areas in Diabetes- Teen version | 12 weeks | 
| DFCS | Diabetes Family Conflict Scale | 12 weeks | 
| Time in Range | Evaluation of percentage of time spent in goal range via continuous glucose monitor system | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AYA, behavioral economics, financial incentive, diabetes, type 1 diabetes, adolescent, young adult