Iterative Beta Testing of Videos for the DIPPer Academy

Type1diabetes Clinical Trial

— DIPPer Academy  

Official title:

An Interactive mHealth App for Better Glycemic Control in Parents of Young Kids With T1D

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385265
• Other study ID #: 15040153
• Secondary ID: 1DP3DK108211-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2022
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to develop DIPPer Academy, a parent-focused, mobile health (mHealth) behavioral intervention to promote glycemic control in young children.

Description:

Because many young children with T1D have glucose levels that exceed targets, investigators need to develop efficacious, accessible, and readily disseminable interventions to help them to improve their glycemic control. To do this, the investigators need efficacious interventions that specifically address the challenges that parents of young children face in daily T1D management. Providers need mHealth interventions that minimize barriers that parents experience when trying to access face-to-face or in clinic interventions. Finally, interventions are needed that are packaged to be easily deployable by other diabetes centers. The investigator's proposed intervention, DIPPer Academy, will include all of these recommended advancements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 1, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 65 Years

Eligibility

Inclusion Criteria:

• Parents of a young child who is between 3-5.99 years old and at least 6 months post T1D diagnosis

• Parents who are English-speaking.

Exclusion Criteria:

• Parents of young children with evidence of type 2 diabetes or monogenic diabetes.

• Parents with evidence of severe psychiatric disorder.

• Parents of young children with a comorbid chronic illness (e.g., renal disease) that requires ongoing care beyond T1D.

• Parents of young children with a history of anemia or medication use that may interact with glycemic control (e.g., systemic steroids).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Behavioral:
• DIPPer Academy
The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.

Other:
• Standard of Care
Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by the diabetes team.

Locations

Country	Name	City	State
United States	The Children's Mercy Hospital	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Glycemic Control	Measure of hemoglobin A1c (HbA1c).	absolute value Post-treatment (Week 33)
Primary	Parent Depressive Symptoms	Center for Epidemiological Studies-Depression Scale Revised (CES-D); higher scores suggest worse outcome. Range 0-60.	absolute value Post-treatment (Week 33)
Primary	Parent Diabetes Distress	Problem Areas in Diabetes Distress- Parent Report Questionnaire. Higher scores reflect worse outcome. Range 0-72	Absolute value at Post-treatment (Week 33)
Secondary	Family Mealtime behaviors_Frequency	Behavioral Pediatrics Feeding Assessment Scale. This is a 35 item scale. This subscale reflects the frequency of perceived mealtime behavior problems (possible range: 35-175). Higher scores represent a worse outcome.	absolute value at Post-treatment (Week 33)
Secondary	Parents' Hypoglycemia Fear	Measured using the Hypoglycemia Fear Survey (HFS-PYC). This is a 26 item measure and higher values represent a worse outcome. Range: 26-130.	absolute value at Post-treatment (Week 33)
Secondary	Parenting Stress- Frequency	Measured using the Pediatric Inventory for Parents. This is a 42 item measure. Measure is scored so that higher values represent a worse outcome. Range: 42-210	Absolute value at Post-treatment (Week 33)
Secondary	Parents' T1D Self-efficacy	Measured using the Parental Self-Efficacy Scale for Diabetes Management. This is an 8 item measure of self-efficacy. It has only a total score (items are summed for the total). Range 8-40. Higher scores represent a better outcome.	Absolute value at Post-treatment (Week 33)
Secondary	Parent Knowledge of T1D	Test of Diabetes Knowledge-5. This is a 41 item measure. There is general knowledge (0-29) and Problem solving (0-11). This is scored based on percent of items correct, so higher scores represent a better outcome.	Absolute value at Post-treatment (Week 33)
Secondary	Behavioral Pediatric Feeding Assessment Scale_Problem	Measured using the Behavioral Pediatrics Feeding Assessment Scale. This is a 35 item scale. This subscale reflects the number of mealtime behaviors that parents identify as problematic (possible range: 0-35). Higher scores represent a worse outcome.	Absolute value at Post-treatment (Week 33)