search
Back to results

Promoting Adolescent Investment In Diabetes Care (InvesT1D)

Primary Purpose

Type 1 Diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial incentive (gain)
Financial incentive (loss)
Sponsored by
Harvard Pilgrim Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring behavioral economics, financial incentive, diabetes, type 1 diabetes, adolescent, AYA, young adult

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seattle Children's Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Gain-framed incentive

Loss-framed incentive

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

HbA1c
Change in HbA1c from baseline to 12 weeks

Secondary Outcome Measures

Glucose monitoring
Frequency of glucose monitoring
Insulin Administration
Insulin pumps and smart insulin pens track administration of all insulin manually delivered by the participant
SCI-R
The Self Care Inventory Revised is a 14-item self-report measure of perceived adherence to diabetes self-care recommendations
PAID-T
Problem Areas in Diabetes- Teen version
DFCS
Diabetes Family Conflict Scale
Time in Range
Evaluation of percentage of time spent in goal range via continuous glucose monitor system

Full Information

First Posted
August 13, 2020
Last Updated
March 18, 2022
Sponsor
Harvard Pilgrim Health Care
Collaborators
Seattle Children's Research Institute (SCRI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04516694
Brief Title
Promoting Adolescent Investment In Diabetes Care
Acronym
InvesT1D
Official Title
Promoting Adolescent Investment In Diabetes Care
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Pilgrim Health Care
Collaborators
Seattle Children's Research Institute (SCRI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
behavioral economics, financial incentive, diabetes, type 1 diabetes, adolescent, AYA, young adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Gain-framed incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
Loss-framed incentive
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Financial incentive (gain)
Intervention Description
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
Intervention Name(s)
Financial incentive (loss)
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c
Description
Change in HbA1c from baseline to 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Glucose monitoring
Description
Frequency of glucose monitoring
Time Frame
12 weeks
Title
Insulin Administration
Description
Insulin pumps and smart insulin pens track administration of all insulin manually delivered by the participant
Time Frame
12 weeks
Title
SCI-R
Description
The Self Care Inventory Revised is a 14-item self-report measure of perceived adherence to diabetes self-care recommendations
Time Frame
12 weeks
Title
PAID-T
Description
Problem Areas in Diabetes- Teen version
Time Frame
12 weeks
Title
DFCS
Description
Diabetes Family Conflict Scale
Time Frame
12 weeks
Title
Time in Range
Description
Evaluation of percentage of time spent in goal range via continuous glucose monitor system
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Seattle Children's Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Promoting Adolescent Investment In Diabetes Care

We'll reach out to this number within 24 hrs