Adherence, Patient, Type 1 Diabetes
Conditions
Keywords
Adolescent, mHealth, executive functioning skills, adherence barriers
Brief summary
The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a web-based intervention addressing adherence barriers in adolescents with T1D.
Detailed description
Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. Evidence demonstrates that adhering to T1D treatment is challenging, especially during adolescence. Non-adherence leads to suboptimal glycemic levels that severely compromise health and quality of life. Suboptimal adherence to T1D treatment regimen is common in \>50% of adolescents and directly related to suboptimal glycemic control, increased risk of hospitalizations for diabetic ketoacidosis, and decreased health-related quality of life (HRQOL). The maximum benefits of current diabetes technology are limited by the knowledge, skills, adherence barriers, and non-adherence behaviors.10-14 Ultimately, adolescents have to overcome these barriers in order to benefit from technological advances. Thus, there is a clear need for behaviorally focused interventions to identify and reduce adherence barriers. The overall objective of this study is to identify adolescents with elevated adherence barriers and provide novel tailored mHealth intervention (Diabetes Journey) targeting these barriers. This study is two phases and includes a small pilot of up to 12 adolescents with type 1 diabetes (Phase 1) and a randomized controlled clinical trial (Phase 2). The randomized controlled clinical trial will examine feasibility, acceptability and preliminary efficacy of Diabetes Journey versus enhanced standard of care (control group) in approximately 256 adolescents with type 1 diabetes. Primary and secondary outcomes include adherence barriers, adherence, health-related quality of life and A1C. Satisfaction and acceptability will also be examined. Mediators and moderators will include executive functioning, diabetes distress, family conflict, depressive symptoms, fear of hypoglycemia and sleep.
Interventions
BEHAVIORALDiabetes Journey
Web-based telehealth intervention focused on adherence barriers and problem-solving
BEHAVIORALEnhanced Standard of Care
General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
Sponsors
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Outcome measures are patient-reported and thus masking will not occur at the level of participant, investigator or outcomes assessor.
Intervention model description
Participants will be randomized to one of two conditions: 1) Diabetes Journey or 2) Enhanced Standard of Care.
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* T1D diagnosis \>1 year * Adolescents with T1D ages 13-17 * Elevations on the Barriers to Diabetes Adherence questionnaire (scores of ≥3 of 53 for the Stress/Burnout and/or Time Pressure/Planning subscales) based on their previous clinic visit scores * Ability to read/speak English (all measures are in English)
Exclusion criteria
* Diagnosis of significant developmental disorders (e.g., autism spectrum disorder, moderate/severe developmental or intellectual disability) * Comorbid medical diagnoses (e.g., cystic fibrosis, asthma) with the exception of endocrine disorders (e.g., Celiac disease, thyroid) * No use of/plans to use non-insulin medication for blood glucose control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale | 6-month follow-up | Stress and Burnout Scale - assesses frustration and feeling burned out by diabetes and its management. Score range from 1-5, with higher scores representing greater barriers. |
| Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale | 6-month follow-up | Time Pressure and Planning Subscale - assesses the time and energy it takes to plan for diabetes self-management, including carrying supplies and making management decisions. Score range from 1-5, with higher scores representing greater barriers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence for Continuous Glucose Monitors | 6-month follow-up | % Time in Range for those on continuous glucose monitors. |
| Adherence | 6-month follow-up | \# blood glucose checks per day |
| Hemoglobin A1C | 6-month follow-up | A blood test that measures the average blood sugar levels over the past two to three months. |
| Adherence to Insulin Boluses | 6-month follow-up | The average of the frequency of insulin boluses delivered per day |
| Adherence for Insulin Pump Users | 6-month follow-up | \# carbohydrate entries per day for insulin pump users |
| Type 1 Diabetes and Life -Youth Report | 6-month follow-up | Total Quality of Life Scores range from 0-100, with higher scores indicating better quality of life |
Countries
United States
Participant flow
Pre-assignment details
After participants were consented, there was a screening process. If participants were elevated on the BDA, they were eligible to be randomized. If they were not elevated, they screen failed. Of the 195 participants who were consented, n=13 screen failed and additional n=20 withdrew prior to randomization. Thus, only n=162 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Diabetes Journey Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving | 97 |
| Enhanced Standard of Care Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided. | 65 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up 1 | Missing Data | 4 | 7 |
| Follow-up 1 | Withdrawal by Subject | 5 | 1 |
| Follow-up 2 | Missing Data | 6 | 5 |
| Follow-up 2 | Withdrawal by Subject | 1 | 1 |
| Intervention | Did not complete all intervention sessions | 2 | 1 |
| Intervention | Withdrawal by Subject | 15 | 3 |
| Post-Intervention | Missing Data | 1 | 2 |
Baseline characteristics
| Characteristic | Enhanced Standard of Care | Total | Diabetes Journey |
|---|---|---|---|
| Age, Continuous | 14.74 years STANDARD_DEVIATION 1.72 | 14.79 years STANDARD_DEVIATION 1.58 | 14.82 years STANDARD_DEVIATION 1.49 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 14 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 148 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 56 Participants | 142 Participants | 86 Participants |
| Sex: Female, Male Female | 37 Participants | 93 Participants | 56 Participants |
| Sex: Female, Male Male | 28 Participants | 69 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 65 |
| other Total, other adverse events | 50 / 97 | 39 / 65 |
| serious Total, serious adverse events | 0 / 97 | 1 / 65 |
Outcome results
Primary
Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale
Stress and Burnout Scale - assesses frustration and feeling burned out by diabetes and its management. Score range from 1-5, with higher scores representing greater barriers.
Time frame: 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes Journey | Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale | 2.36 score on a scale | Standard Deviation 0.9 |
| Enhanced Standard of Care | Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale | 2.31 score on a scale | Standard Deviation 1.05 |
Primary
Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale
Time Pressure and Planning Subscale - assesses the time and energy it takes to plan for diabetes self-management, including carrying supplies and making management decisions. Score range from 1-5, with higher scores representing greater barriers.
Time frame: 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes Journey | Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale | 1.92 score on a scale | Standard Deviation 0.58 |
| Enhanced Standard of Care | Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale | 2.03 score on a scale | Standard Deviation 0.89 |
Secondary
Adherence
\# blood glucose checks per day
Time frame: 6-month follow-up
Secondary
Adherence for Continuous Glucose Monitors
% Time in Range for those on continuous glucose monitors.
Time frame: 6-month follow-up
Secondary
Adherence for Insulin Pump Users
\# carbohydrate entries per day for insulin pump users
Time frame: 6-month follow-up
Secondary
Adherence to Insulin Boluses
The average of the frequency of insulin boluses delivered per day
Time frame: 6-month follow-up
Secondary
Hemoglobin A1C
A blood test that measures the average blood sugar levels over the past two to three months.
Time frame: 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes Journey | Hemoglobin A1C | 8.06 percentage of glycosylated hemoglobin | Standard Deviation 1.72 |
| Enhanced Standard of Care | Hemoglobin A1C | 7.98 percentage of glycosylated hemoglobin | Standard Deviation 1.67 |
Secondary
Type 1 Diabetes and Life -Youth Report
Total Quality of Life Scores range from 0-100, with higher scores indicating better quality of life
Time frame: 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetes Journey | Type 1 Diabetes and Life -Youth Report | 65.84 score on a scale | Standard Deviation 14.71 |
| Enhanced Standard of Care | Type 1 Diabetes and Life -Youth Report | 65.82 score on a scale | Standard Deviation 18.32 |