Promoting Adolescent Investment In Diabetes Care

NCT04516694 | Completed

• 1 other identifier: 1540260
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

behavioral economics; financial incentive; diabetes; type 1 diabetes; adolescent; AYA; young adult

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Change in HbA1c from baseline to 12 weeks

  12 weeks

Secondary Outcomes (6)

• Glucose monitoring

  12 weeks

• Insulin Administration

  12 weeks

• SCI-R

  12 weeks

• PAID-T

  12 weeks

• DFCS

  12 weeks

Study Arms (3)

Control

NO INTERVENTION

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.

Gain-framed incentive

EXPERIMENTAL

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)

Loss-framed incentive

EXPERIMENTAL

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)

Interventions

Financial incentive (gain) 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.

Gain-framed incentive

Financial incentive (loss) 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.

Loss-framed incentive

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Seattle Children's Hospital: collaborator

Study Sites (1)

Seattle Children's Research Institute

Seattle, Washington, 98121, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: September 10, 2020
• Primary Completion: December 21, 2021
• Study Completion: January 8, 2022
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)