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| ID | Type | Description | Link |
|---|---|---|---|
| MSN164403 | Other Identifier | Patient-Centered Outcomes Research Institute | |
| IRB 00016300 | Other Identifier | Study Team |
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| Name | Class |
|---|---|
| Medical College of Wisconsin | OTHER |
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Children with type 1 diabetes face complex self-management regimens which make adherence challenging and ultimately result in poor blood sugar control. Several common barriers interfere with diabetes control such as limited knowledge or challenges with staying motivated. Efficacious strategies exist to improve diabetes self-management including, but not limited to, diabetes education or family therapy. Patients and families often do not access these strategies, in part due to healthcare systems-based issues such as accessibility, provider availability, or insurance coverage.
A family-centered approach has been suggested to tailor diabetes care to provide improved outcomes for each child. Family-centered care engages the family in the decision-making about the child's health and well-being. In this study we will take a family-centered approach to providing diabetes self-management by identifying families' unique self-management barriers through a 10-minute survey tool called PRISM (Problem Recognition in Illness Self-Management). Based upon the results of PRISM, we will provide tailored self-management resources (interventions) to meet the family's needs. We will coordinate group-based delivery of the resources with routine diabetes clinic visits. These group-based resources will be delivered in four 75-minute sessions over a year.
The primary goal of this study is to compare the effectiveness of family-centered tailoring of diabetes self-management resources with the untailored approach of usual care. We hypothesize that the family-centered model of care with tailored resources will improve the outcomes of glycemic control and quality of life among children with type 1 diabetes and their parents.
This project's long-term goal is to develop a system-level method to move existing, efficacious self-management resources into the hands of children with type 1 diabetes and their families. Over 175,000 US children have type 1 diabetes and face a lifetime of self-management decisions in an attempt to delay or prevent complications, avoid hypoglycemia, and maintain quality of life for themselves and their parents. Although efficacious self-management resources exist, most children with diabetes struggle to manage their disease. Several barriers to diabetes management exist, including knowledge, motivation, and family interactions. Because barriers are unique for each child and family, family-centered approaches are recommended. Currently, no systematic approach exists to identify and address each family's self-management barriers. Information from PRISM (Problem Recognition in Illness Self-Management), a 10-minute survey tool, could help families and clinicians make better decisions to address these barriers, ultimately improving outcomes, fostering family-centered diabetes care, and optimizing resource use.
This randomized, pragmatic trial will compare outcomes from PRISM-based, family-centered tailoring of self-management resources (intervention) to outcomes from the untailored approach of usual care. Our specific aims are to assess the effect of family-centered tailoring of diabetes self-management resources on outcomes that matter to the children and parents: glycemic control (A1c and fear of hypoglycemia) and child and parent quality of life.
Children 8-16 years old with diabetes (150 each in usual care and intervention groups) and their parents will be enrolled at two large pediatric diabetes clinics. We will 1) use PRISM to identify families' unique self-management barriers; 2) tailor self-management resources to identified barriers; and 3) coordinate group-based delivery of the resources with routine diabetes visits. The group-based resources will be delivered in four 75-minute sessions over 12 months. A1c will be assessed after sessions, along with fear of hypoglycemia and quality of life for the child and parent. We will compare outcomes with mixed-effects models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Resources | Experimental | Use of PRISM screening tool to identify self-management needs and to provide tailored group session resources over 1 year |
|
| Usual Care | No Intervention | Patients and families obtain routine multidisciplinary diabetes care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Resources | Behavioral | Based upon PRISM screening tool results that identifies self-management barriers, patient/family will receive self-management resources matched to their barriers. These resources could be focused on: 1. Understanding and organizing care; 2. Motivation to self-manage; and 3. Family Teamwork. Group session of about 6 families with the same barrier will meet four times fo 75-minutes over a year, at the clinic site on same date as routine clinic visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Mean change in A1c per month (slope), during and post-intervention. | Up to 5 time points during the intervention (12 months) and up to 4 time points in the post-intervention period (12 months) |
| Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Mean change in child quality of life per month (slope), during and post-intervention. Child quality of life is measured by the PedsQL Diabetes Module. Possible scores range from 0 to 100 with higher scores indicating better quality of life. Positive slopes reflect improving quality of life. | Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months) |
| Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Mean change in parent quality of life per month (slope), during and post-intervention. Parent quality of life is measured by the PedsQL Family Impact Module. Possible scores range from 0 to 100 with higher scores indicating better quality of life. Positive slopes reflect improving quality of life. | Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Mean change in parent fear of hypoglycemia per month (slope), during and post-intervention. Parent fear of hypoglycemia is measured by the Hypoglycemia Fear Survey Worry Subscale. Possible scores range from 15 to 75 with higher scores indicating greater fear of hypoglycemia. Positive slopes reflect increasing fear of hypoglycemia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth D Cox, MD,PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | United States | ||
| Children's Hospital of Wisconsin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31355957 | Derived | Fiallo-Scharer R, Palta M, Chewning BA, Rajamanickam V, Wysocki T, Wetterneck TB, Cox ED. Impact of family-centered tailoring of pediatric diabetes self-management resources. Pediatr Diabetes. 2019 Nov;20(7):1016-1024. doi: 10.1111/pedi.12899. Epub 2019 Aug 8. | |
| 28450194 | Derived | Fiallo-Scharer R, Palta M, Chewning BA, Wysocki T, Wetterneck TB, Cox ED. Design and baseline data from a PCORI-funded randomized controlled trial of family-centered tailoring of diabetes self-management resources. Contemp Clin Trials. 2017 Jul;58:58-65. doi: 10.1016/j.cct.2017.04.007. Epub 2017 Apr 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored Resources | Four 75-minute group-based self-management resource sessions, matched to self-management barriers identified by PRISM survey |
| FG001 | Usual Care | Routine multidisciplinary diabetes care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored Resources | Four 75-minute group-based self-management resource sessions, matched to self-management barriers identified by PRISM survey |
| BG001 | Usual Care | Routine multidisciplinary diabetes care |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Mean change in A1c per month (slope), during and post-intervention. | 214 participants were analyzed for up to 5 time points during the intervention and up to 4 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families. | Posted | Mean | Standard Error | Percent HbA1c per month | Up to 5 time points during the intervention (12 months) and up to 4 time points in the post-intervention period (12 months) | HbA1c Observations | HbA1c Observations |
|
24 months
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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 | Tailored Resources | Four 75-minute group-based self-management resource sessions, matched to self-management barriers identified by PRISM survey. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Cox | University of Wisconsin School of Medicine and Public Health | 608-263-9104 | ecox@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2017 | Nov 22, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2017 | Nov 22, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Up to 2 time points during the intervention (12 months) and up to 2 time points in the post-intervention period (12 months) |
| Milwaukee |
| Wisconsin |
| 53201 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Clinical Site | Count of Participants | Participants |
|
| Relationship to child: Mother | Count of Participants | Participants |
|
| Insulin pump use | Count of Participants | Participants |
|
| Baseline A1c | Mean | Standard Deviation | Percent A1c |
|
| Baseline Child Quality of Life (QOL) | Measured with PedsQL Diabetes Module, with values ranging 0-100 and higher values representing higher quality of life. | Mean | Standard Deviation | units on a scale |
|
| Baseline Parent Quality of Life (QOL) | Measured with PedsQL Family Impact Module, with values ranging 0-100 and higher values representing higher quality of life. | Mean | Standard Deviation | units on a scale |
|
| Baseline Parent Fear of Hypoglycemia (FOH) | Measured with the Worry Subscale from the Hypoglycemia Fear Survey Parent Version, with values ranging 0-75 and higher values representing greater fear of hypoglycemia. | Mean | Standard Deviation | units on a scale |
|
Participants who received tailored resources. |
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|
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| Primary | Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Mean change in child quality of life per month (slope), during and post-intervention. Child quality of life is measured by the PedsQL Diabetes Module. Possible scores range from 0 to 100 with higher scores indicating better quality of life. Positive slopes reflect improving quality of life. | 214 participants were analyzed for up to 2 time points during the intervention and up to 3 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families. | Posted | Mean | Standard Error | QOL scores per month | Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months) | Quality of Life Measures | Quality of Life Measures |
|
|
|
|
| Primary | Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Mean change in parent quality of life per month (slope), during and post-intervention. Parent quality of life is measured by the PedsQL Family Impact Module. Possible scores range from 0 to 100 with higher scores indicating better quality of life. Positive slopes reflect improving quality of life. | 214 parents were analyzed for up to 2 time points during the intervention and up to 3 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families. | Posted | Mean | Standard Error | QOL scores per month | Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months) | Quality of Life Measures | Quality of Life Measures |
|
|
|
|
| Secondary | Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Mean change in parent fear of hypoglycemia per month (slope), during and post-intervention. Parent fear of hypoglycemia is measured by the Hypoglycemia Fear Survey Worry Subscale. Possible scores range from 15 to 75 with higher scores indicating greater fear of hypoglycemia. Positive slopes reflect increasing fear of hypoglycemia. | 214 parents were analyzed for up to 2 time points during the intervention and up to 2 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families. | Posted | Mean | Standard Error | FOH scores per month | Up to 2 time points during the intervention (12 months) and up to 2 time points in the post-intervention period (12 months) | Fear of Hypoglycemia Measures | Fear of Hypoglycemia Measures |
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|
| 0 |
| 106 |
| 0 |
| 106 |
| 0 |
| 106 |
| EG001 | Usual Care | Routine multidisciplinary diabetes care | 0 | 108 | 0 | 108 | 0 | 108 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| During the post-intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms. | Mixed Models Analysis | Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline. | 0.74 | The a priori threshold for statistical significance was p<0.05. | Mean Difference (Net) | -0.074 | 2-Sided | 95 | -0.517 | 0.369 | Positive values indicate a clinical benefit. | Other |
| During the post-intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms. | Mixed Models Analysis | Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline. | 0.97 | The a priori threshold for statistical significance was p<0.05. | Mean Difference (Net) | -0.009 | 2-Sided | 95 | -0.467 | 0.448 | Positive values indicate a clinical benefit. | Other |
| During the post-intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms. | Mixed Models Analysis | Adjustments were made for study stratification variables and covariates that were imbalanced between study arms at baseline. | 0.98 | The a priori threshold for statistical significance was p<0.05. | Mean Difference (Net) | -0.006 | 2-Sided | 95 | -0.384 | 0.373 | Positive values indicate a clinical benefit. | Other |