Clinical trial NCT04516694: Promoting Adolescent Investment In Diabetes Care
Official title: Promoting Adolescent Investment In Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: behavioral economics
financial incentive
diabetes
type 1 diabetes
adolescent
AYA
young adult
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
First posted: 2020-08-18
Enrollment: 39
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Glucose monitoring
timeFrame: 12 weeks
measure: Insulin Administration
timeFrame: 12 weeks
measure: SCI-R
timeFrame: 12 weeks
measure: PAID-T
timeFrame: 12 weeks
measure: DFCS
timeFrame: 12 weeks
measure: Time in Range
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
References: