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| Name | Class |
|---|---|
| Children's Mercy Hospital Kansas City | OTHER |
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Pilot of a novel video-based telemedicine intervention to reduce fear of hypoglycemia in parents of young children with type 1 diabetes.
This was a two group randomized controlled study using a wait-list control design. All participating parents had the opportunity to receive 10 video-based telemedicine sessions administered over 13 weeks. Study assessments took place at baseline, post-treatment, and 3 month followup. Study outcomes included parent reported hypoglycemia fear, parenting stress, diabetes distress, and child glycated hemoglobin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REDCHiP | Experimental | 10 week video-based telemedicine intervention to reduce parents hypoglycemia fear |
|
| Waitlist | No Intervention | 10 week no intervention to provide waitlist control condition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REDCHiP | Behavioral | 10 week video-based telemedicine intervention to reduce hypoglycemia fear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia Fear Survey | Hypoglycemia Fear Survey-Parents of Young Children. This is a measure of parents' perceived hypoglycemia fear. Higher scores suggest greater fear (worse outcome). Total possible range: 26-130. | absolute value at post-treatment (week 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Child Hemoglobin A1c | Child hemoglobin A1c- biological marker of glycemic control | absolute value at post-treatment (week 14) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35045389 | Derived | Patton SR, Monzon AD, Noser AE, Clements MA. Physical Activity, Glycemic Variability, and Parental Hypoglycemia Fear in Preschoolers With Type 1 Diabetes. Pediatr Exerc Sci. 2022 Jan 19;34(3):135-140. doi: 10.1123/pes.2021-0046. Print 2022 Aug 1. | |
| 31610073 | Derived | Patton SR, Clements MA, Marker AM, Nelson EL. Intervention to reduce hypoglycemia fear in parents of young kids using video-based telehealth (REDCHiP). Pediatr Diabetes. 2020 Feb;21(1):112-119. doi: 10.1111/pedi.12934. Epub 2019 Nov 3. |
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the study over-recruited the original study protocol by 3 parents; pre-assignment, parents completed baseline assessment measures;
recruitment in clinic and by telephone
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| ID | Title | Description |
|---|---|---|
| FG000 | REDCHiP | 10 week video-based telemedicine intervention to reduce parents hypoglycemia fear REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear |
| FG001 | Waitlist | 10 week no intervention to provide waitlist control condition |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | REDCHiP | 10 week video-based telemedicine intervention to reduce parents hypoglycemia fear REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear |
| BG001 | Waitlist |
| 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 | Hypoglycemia Fear Survey | Hypoglycemia Fear Survey-Parents of Young Children. This is a measure of parents' perceived hypoglycemia fear. Higher scores suggest greater fear (worse outcome). Total possible range: 26-130. | 43 parents enrolled and were randomized; 36 parents completed the treatment. Therefore number analyzed reflects 36 parents who completed treatment. | Posted | Mean | Standard Deviation | units on a scale | absolute value at post-treatment (week 14) |
|
through study completion, average 7 months
Adverse event = episodes of prolong low blood glucose value (>1 hour); increase in frequency of any low blood glucose events (glucose <70 mg/dl)
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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 | REDCHiP | 10 week video-based telemedicine intervention to reduce parents hypoglycemia fear REDCHiP: 10 week video-based telemedicine intervention to reduce hypoglycemia fear |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susana Patton | Nemours Children's Health-Jacksonville | 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 | Oct 12, 2017 | Jan 16, 2022 | Prot_SAP_001.pdf |
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randomized control pilot using a waitlist control group
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| 31517512 | Derived | Marker AM, Monzon AD, Nelson EL, Clements MA, Patton SR. An Intervention to Reduce Hypoglycemia Fear in Parents of Young Kids with Type 1 Diabetes Through Video-Based Telemedicine (REDCHiP): Trial Design, Feasibility, and Acceptability. Diabetes Technol Ther. 2020 Jan;22(1):25-33. doi: 10.1089/dia.2019.0244. Epub 2019 Nov 13. |
10 week no intervention to provide waitlist control condition
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | one parent from each condition did not complete all the baseline assessment measures | Mean | Standard Deviation | years |
|
| Sex: Female, Male | one parent from each condition did not complete all baseline assessments | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | one parent in the waitlist control group did not complete this survey | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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10 week no intervention to provide waitlist control condition
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| Secondary | Child Hemoglobin A1c | Child hemoglobin A1c- biological marker of glycemic control | 43 parents enrolled and were randomized; 36 parents completed the treatment. Therefore number analyzed reflects 36 parents who completed treatment. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin cells | absolute value at post-treatment (week 14) |
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|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Waitlist | 10 week no intervention to provide waitlist control condition | 0 | 21 | 0 | 21 | 0 | 21 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|