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| ID | Type | Description | Link |
|---|---|---|---|
| 1DP3DK108211-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DIPPer Academy | Experimental | Parents randomized to this group will participate in the DIPPer Academy curriculum. |
|
| Standard of Care Control | Active Comparator | Parents randomized to this group will receive care as usual from their child's diabetes provider |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIPPer Academy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Child Glycemic Control | Measure of hemoglobin A1c (HbA1c). | absolute value Post-treatment (Week 33) |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Parents' Hypoglycemia Fear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eve-Lynn Nelson, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| The Children's Mercy Hospital |
pre-assignment all parents completed baseline assessment measures
recruited in clinic or by telephone.
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| ID | Title | Description |
|---|---|---|
| FG000 | DIPPer Academy- Parents | Parents randomized to this group will participate in the DIPPer Academy curriculum via the internet. |
| FG001 | Standard of Care Control- Parents | Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. |
| FG002 | DIPPer Academy- Children | Parents randomized to this group will participate in DIPPer Academy via the internet. We collect Child HbA1c levels. Children do not receive treatment. |
| FG003 | Standard of Care- Children | Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. We collect Child HbA1c levels. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
overall baseline participant number is consistent with flow documentation
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| ID | Title | Description |
|---|---|---|
| BG000 | DIPPer Academy- Parents | Parents randomized to this group will participate in the DIPPer Academy curriculum. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Child Glycemic Control | Measure of hemoglobin A1c (HbA1c). | lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin cells | absolute value Post-treatment (Week 33) |
|
through study completion, average 7 months
Definition for Serious Adverse Events and Adverse Events did not differ from clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DIPPer Academy- Parents | Parents randomized to this group will participate in the DIPPer Academy curriculum via the internet. |
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Small sample size leading to limited power to examine for treatment effects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susana Patton | Nemours Children's Health | 904-697-2000 | susana.patton@nemours.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2021 | Feb 7, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of Care | Other | Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by the diabetes team. |
|
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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Kansas City |
| Missouri |
| 64108 |
| United States |
| BG001 | Standard of Care Control- Parents | Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. |
| BG002 | DIPPer Academy- Children | Parents randomized to this group will participate in the DIPPer Academy curriculum. We collect children's HbA1c level. 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. Children do not receive treatment. |
| BG003 | Standard of Care Control- Children | Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. We collect children's HbA1c level. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. |
|
|
|
| Primary | Parent Depressive Symptoms | Center for Epidemiological Studies-Depression Scale Revised (CES-D); higher scores suggest worse outcome. Range 0-60. | lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves. | Posted | Mean | Standard Deviation | units on a scale | 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 | lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves. | Posted | Mean | Standard Deviation | units on a scale | 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. | lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves. | Posted | Mean | Standard Deviation | units on a scale | 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. | lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves. | Posted | Mean | Standard Deviation | units on a scale | 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 | lost to follow-up n=5 families in DIPPer group and n=2 families in standard care at 33 weeks; families withdrew themselves. | Posted | Mean | Standard Deviation | units on a scale | 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. | lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves. | Posted | Mean | Standard Deviation | units on a scale | 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. | lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves. | Posted | Mean | Standard Deviation | percentage of correct items | 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. | lost to follow-up n=5 parents in DIPPer group and n=2 parents in standard care at 33 weeks; parents withdrew themselves. | Posted | Mean | Standard Deviation | score on a scale | Absolute value at Post-treatment (Week 33) |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Standard of Care Control- Parents | Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | DIPPer Academy- Children | Parents randomized to this group will participate in the DIPPer Academy curriculum via the internet. Children did not receive treatment. We collected child HbA1c. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Standard of Care Control- Children | Standard of Care: Parents in the standard of care control group will be instructed to manage their child's T1D as recommended by their diabetes team. We collected child HbA1c | 0 | 9 | 0 | 9 | 0 | 9 |
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