InvesT1D: Promoting Adolescent Investment In Diabetes Care

Sponsor

Harvard Pilgrim Health Care (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04516694

Collaborator

Seattle Children's Research Institute (SCRI) (Other)

Enrollment

Location

Arms

21.6

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Behavioral: Financial incentive (gain) Behavioral: Financial incentive (loss)	N/A

Detailed Description

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Promoting Adolescent Investment In Diabetes Care

Actual Study Start Date :

Sep 10, 2020

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control 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 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) 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.
Experimental: Loss-framed incentive 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) 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.

Arm

Intervention/Treatment

No Intervention: Control

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

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)

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.

Experimental: Loss-framed incentive

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)

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.

Outcome Measures

Primary Outcome Measures

HbA1c [12 weeks]
Change in HbA1c from baseline to 12 weeks

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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