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Trial record 78 of 89 for:    NIDDK endocrine and diabetes | Recruiting, Not yet recruiting, Available Studies

Iterative Beta Testing of Videos for the DIPPer Academy (DIPPer Academy)

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ClinicalTrials.gov Identifier: NCT03385265
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The purpose of this research is to develop DIPPer Academy, a family-focused, mobile health (mHealth) behavioral intervention to promote glycemic control and type 1 diabetes (T1D) adherence in young children.

Condition or disease Intervention/treatment Phase
Type1diabetes Behavioral: DIPPer Academy Behavioral: Standard of Care Not Applicable

Detailed 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, as well as learning activities that are targeted to the ever evolving abilities of young children. Providers need mHealth interventions that minimize barriers that families 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Interactive mHealth App for Better Glycemic Control in Families of Young Kids With T1D
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DIPPer Academy
Families randomized to this group will participate in the DIPPer Academy curriculum.
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.

Active Comparator: Standard of Care Control 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.

Behavioral: Standard of Care
Families in the standard of care control group will be instructed to manage their child's T1D as recommended.




Primary Outcome Measures :
  1. Child glycemic control [ Time Frame: Change from Baseline to Post-treatment (Week 33) ]
    Measure of hemoglobin A1c (HbA1c).

  2. T1D adherence [ Time Frame: Change from Baseline to Post-treatment (Week 33) ]
    Measured via mean frequency of blood glucose (BG) checks and mealtime insulin bolus scores.

  3. Mean daily glucose [ Time Frame: Change from Baseline to Post-treatment (Week 33) ]
    Measured via 14-day glucometer downloads. This will be collected at each assessment point and biweekly during the intervention. Measure will be mean over the time period.


Secondary Outcome Measures :
  1. Family mealtime behaviors [ Time Frame: Change from Baseline to Post-treatment (Week 33) ]
    Measured using the Behavioral Pediatrics Feeding Assessment Scale. This is a 35 item scale. It contains four subscales: Child Frequency (25-125), Child Problems (0-25), Parent Frequency (10-50), Parent Problem (0-10). All subscales are scored so that higher values represent a worse outcome.

  2. Parents' hypoglycemia fear [ Time Frame: Change from Baseline to Post-treatment (Week 33) ]
    Measured using the Hypoglycemia Fear Survey (HFS-PYC). This is a 26 item measure. It contains two subscales: Behavior (10-50) and Worry (15-75). All subscales are scored so that higher values represent a worse outcome.

  3. Parenting stress [ Time Frame: Change from Baseline to Post-treatment (Week 33) ]
    Measured using the Pediatric Inventory for Parents. This is a 42 item measure. It contains two subscales: Frequency (42-210) and Difficulty (42-210). All subscales are scored so that higher values represent a worse outcome.

  4. Parents' T1D self-efficacy [ Time Frame: Change from Baseline to Post-treatment (Week 33) ]
    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.

  5. Parent knowledge of T1D [ Time Frame: Change from Baseline to Post-treatment (Week 33) ]
    Test of Diabetes Knowledge-5. This is a 41 item measure. There is general knowledge (0-29) and Problem solving (0-11). Higher scores represent a better outcome.

  6. Parents' depression symptoms [ Time Frame: Change from Baseline to Post-treatment (Week 33) ]
    Measured using the Center for Epidemiological Studies-Depression Scale. This is a 20 item measure. It has only a total score (items are summed for the total). Range 0-60. Higher scores represent a worse outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Families of a young child who is between 1-5.99 years old and at least 6 months post T1D diagnosis
  • Families who are English-speaking.

Exclusion Criteria:

  • Young children with evidence of type 2 diabetes or monogenic diabetes.
  • Children/parents with evidence of severe psychiatric disorder.
  • Young children with a comorbid chronic illness (e.g., renal disease) that requires ongoing care beyond T1D.
  • Young children with a history of anemia or medication use that may interact with glycemic control (e.g., systemic steroids).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385265


Contacts
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Contact: Eve-Lynn Nelson, PhD (913) 588-6323 enelson2@kumc.edu
Contact: Susana R Patton, PhD ABPP CDE 904-697-3595 susana.patton@nemours.org

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
United States, Missouri
The Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Principal Investigator: Mark Clements, MD         
Principal Investigator: Kathy Goggin, PhD         
Sponsors and Collaborators
University of Kansas Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Eve-Lynn Nelson, PhD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03385265     History of Changes
Other Study ID Numbers: 15040153
1DP3DK108211-01 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases