Promoting Adolescent Investment In Diabetes Care

NCT ID: NCT04516694

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2022-01-08

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.

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).

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Financial incentive (gain)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Financial incentive (loss)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

Harvard Pilgrim Health Care

OTHER

Sponsor Role: lead

Responsible Party

Davene R. Wright

Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seattle Children's Research Institute

Seattle, Washington, United States

Countries

United States

Other Identifiers

1540260

Identifier Type: -

Identifier Source: org_study_id