InvesT1D: Promoting Adolescent Investment in Diabetes Care

Part of paid clinical trials in Seattle, Washington.

Sponsor
Harvard Pilgrim Health Care
Study ID
NCT06384911
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Financial Incentives Program — BEHAVIORAL
    Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals.

Study Details

The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes. Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels, as well as adolescent and caregiver person-reported outcomes between groups.

Key Dates

Start date
Jun 25, 2024
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (low-value incentive, 6 months [24 weeks])
    If the participant is assigned to Group A, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $294 over a period of 24 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $66 over a period of 24 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $360 over a period of 24 weeks.
  • Experimental: Group B (high-value incentive, 6 months [24 weeks])
    If the participant is assigned to Group B, they would receive $3.50 for each day that they meet their diabetes self-management goal. This equates to up to $98 every 4 weeks ($3.50 x 28 days = $98), or up to $588 over a period of 24 weeks. They would also receive $5.50 for each week that they meet their clinical outcome goal. This equates to up to $22 every 4 weeks ($5.50 x 4 weeks), or up to $132 over a period of 24 weeks. In total, they could earn up to $120 ($98 + $22) every 4 weeks, or up to $720 over a period of 24 weeks.
  • Experimental: Group C (low-value incentive, 12 months [48 weeks])
    If the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks.
  • Experimental: Group D (high-value incentive, 12 months [48 weeks])
    If the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks.
  • No Intervention: Group E (usual care, 6 months [24 weeks])
    Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. 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. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits.
  • No Intervention: Group F (usual care, 12 months [48 weeks])
    Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. 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. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits.

Primary Outcome Measure

Time In Range [ Time Frame: Change over 12-18 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Children'sSeattleWashington98105
Ciara A DeGraff, BA
206-884-1809
Beth Loots, MPH, MSW
206-884-4488
Catherine Pihoker, MD (PRINCIPAL_INVESTIGATOR)

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