Iterative Beta Testing of Videos for the DIPPer Academy

NCT ID: NCT03385265

Last Updated: 2022-03-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type1diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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DIPPer Academy

Parents randomized to this group will participate in the DIPPer Academy curriculum.

Group Type EXPERIMENTAL

DIPPer Academy

Intervention Type BEHAVIORAL

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.

Standard of Care Control

Parents randomized to this group will receive care as usual from their child's diabetes provider

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

3 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eve-Lynn Nelson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

The Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1DP3DK108211-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15040153

Identifier Type: -

Identifier Source: org_study_id

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