This study aims to identify the unmet psychoeducational needs of parents of children 8-12 years of age using insulin pump and CGM for pediatric T1D management and to leverage that information to develop an innovative app-based psychoeducational intervention to optimize use of these technologies and improve T1D outcomes.
Despite increased use of insulin pumps and continuous glucose monitors (CGM) for pediatric type 1 diabetes (T1D) management and research studies showing benefits from the use of these devices, real-world glycemic control among youth with T1D has worsened in recent years. Although greater youth and parental diabetes knowledge is associated with better glycemic control, education alone is not sufficient to bring about the behavioral changes needed to improve outcomes in T1D. Psychoeducation recognizes the need to blend educational and behavioral approaches, including problem-solving and goal-setting, to support parents in developing optimal T1D management approaches. There are currently a lack of effective standardized tools to support patients and families in developing the knowledge and behavioral strategies needed to optimize the use of diabetes technologies. The development of innovative family-centered psychoeducational tools addressing both behavior and knowledge will help to realize the full potential of diabetes technologies to improve glycemic control and quality of life while ultimately preventing or delaying the development of both acute and long-term complications of T1D. Interviews with parent-child dyads and diabetes clinicians will be used to identify the unmet parental psychoeducational needs regarding insulin pumps and CGM. These results will inform the use of instructional design to adapt an existing app-delivered diabetes technology curriculum to meet the specific needs of parents of children with T1D. Finally, the investigators will assess the feasibility and acceptability of this novel family-facing psychoeducational app-delivered intervention in a non-randomized pilot study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
app-delivered curriculum to provide psychoeducational education surrounding diabetes technology use
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Study Recruitment
Percentage of eligible patients who are approached and enroll in the study in Arm 3.
Time frame: Arm 3: Months 30-60
Intervention Satisfaction
Score on a survey developed to assess satisfaction with the Technology Knowledge Optimization Type 1 Diabetes: Parents curriculum in Arm 3. Scores range from 0-100 with higher scores reflecting greater satisfaction.
Time frame: Arm 3: Months 30-60
Perceived Intervention Utility
Score on a survey developed to assess the perceived utility of the Technology Knowledge Optimization Type 1 Diabetes: Parents curriculum during Arm 3. Scores range from 0-100 with higher scores reflecting greater perceived utility.
Time frame: Arm 3: Months 30-60
Intervention Completion
Percentage of enrolled participants who complete the TeKnO T1D: Parents Curriculum in Arm 3.
Time frame: Arm 3: Months 30-60
Intervention Retention
Percentage of enrolled participants who complete the entire intervention for Arm 3.
Time frame: Arm 3: Months 30-60
Hemoglobin A1c
Hemoglobin A1c will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
CGM Mean Sensor Glucose
CGM mean sensor glucose will be assessed prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
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Time frame: months 0-60
CGM Glucose Management Indicator
The Glucose Management Indicator will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
CGM Coefficient of Variation of the Mean
The Coefficient of Variation of the Mean will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. .
Time frame: Arm 3: Months 30-60
CGM Time in Range (70-180 mg/dL)
CGM Time in Range (70-180 mg/dL) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
CGM Time Below Range (<70 mg/dL)
CGM Time Below Range (\<70 mg/dL) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
CGM Time Above Range (<180 mg/dL)
CGM Time Above Range (\<180 mg/dL) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
CGM Wear Time
The percentage of CGM wear time will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
Total Daily Insulin Dose
Total Daily Insulin Dose will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
Total Daily Basal Insulin Dose
Total Daily Basal Insulin Dose will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
Percent Basal Insulin Dose
The percentage of the total daily insulin derived from basal insulin (basal insulin/ total daily insulin dose) will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
Number of boluses per day
The number of boluses per day will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
Carbohydrate intake logged on insulin pump
The number of grams of carbohydrate intake logged on insulin pump will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
Episodes of Severe Hypoglycemia
The number of episodes of severe hypoglycemia will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
Emergency Department Visits
The number of diabetes-related emergency department visits will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
Hospital Admissions
The number of diabetes-related hospital admissions will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
Episodes of Diabetic Ketoacidosis
The number of episodes of diabetic ketoacidosis will be assessed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion.
Time frame: Arm 3: Months 30-60
Parent Diabetes-Specific Quality of Life
The Type 1 Diabetes and Life (T1DAL) is a validated survey assessing diabetes-specific quality of life. T1DAL will be will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater quality of life.
Time frame: Arm 3: Months 30-60
Parent Emotional Distress Related to T1D
Parents of Children (P-PAID) is a validated survey assessing emotional distress related to T1D. P-PAID will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 15 to 96 with higher scores reflecting greater emotional distress.
Time frame: Arm 3: Months 30-60
Parent Diabetes Self-Management
The Diabetes Management Questionnaire (DMQ) is a validated survey assessing diabetes self-management. The DMQ will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater adherence to diabetes management.
Time frame: Arm 3: Months 30-60
Parent Perceived CGM Benefits and Burdens
CGM Benefits and Burdens scale is a validated survey exploring perceived benefits and burdens of CGM use. CGM Benefits and Burdens will be completed prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scoring of the CGM Benefits subscale ranges from 1 to 40 with higher scores reflecting greater perceived benefits. Scoring of the CGM Burdens subscale ranges from 1 to 40 with higher scores reflecting less perceived burden.
Time frame: months 0-60
Parent Diabetes Technology Knowledge
A survey assessing diabetes technology knowledge will be developed. This survey will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater knowledge.
Time frame: Arm 3: Months 30-60
Child Diabetes-Specific Quality of Life
The Type 1 Diabetes and Life (T1DAL) is a validated survey assessing diabetes-specific quality of life. T1DAL will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater quality of life.
Time frame: Arm 3: Months 30-60
Child Emotional Distress Related to T1D
Problem Areas in Diabetes- Child Version (PAID-C) is a validated survey assessing emotional distress related to T1D. PAID-C will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion). Scores range from 11 to 84 with higher scores reflecting greater emotional distress.
Time frame: Arm 3: Months 30-60
Child Diabetes Self-Management
The Diabetes Management Questionnaire (DMQ) is a validated survey assessing diabetes self-management. The DMQ will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scores range from 0 to 100 with higher scores reflecting greater adherence to diabetes management.
Time frame: Arm 3: Months 30-60
Child Perceived CGM Benefits and Burdens
CGM Benefits and Burdens scale is a validated survey exploring perceived benefits and burdens of CGM use. CGM Benefits and Burdens will be completed in Arm 3 prior to the curriculum start, upon completion of the TeKnO T1D: Parents curriculum, and 12 weeks after the curriculum completion. Scoring of the CGM Benefits subscale ranges from 1 to 40 with higher scores reflecting greater perceived benefits. Scoring of the CGM Burdens subscale ranges from 1 to 40 with higher scores reflecting less perceived burden.
Time frame: Arm 3: Months 30-60