Clinical Trials Directory

Trials / Completed

CompletedNCT04516694

Promoting Adolescent Investment In Diabetes Care

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
39 (actual)
Sponsor
Harvard Pilgrim Health Care · Academic / Other
Sex
All
Age
12 Years – 18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALFinancial 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.
BEHAVIORALFinancial 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.

Timeline

Start date
2020-09-10
Primary completion
2021-12-21
Completion
2022-01-08
First posted
2020-08-18
Last updated
2024-03-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04516694. Inclusion in this directory is not an endorsement.