Diabetes Mellitus, Type 1
Conditions
Keywords
Family centered care, Patient centered care, Diabetes Mellitus, Type 1, Problem Recognition in Illness Self-Management (PRISM)
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTailored Resources
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.
Sponsors
Medical College of Wisconsin
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Children and adolescents with type 1 diabetes and their parents who receive care at one of two sites in Wisconsin. * Planning to continue care at clinic for the next 2 years. * English speaking * Diagnosed with diabetes for \> 12 months
Exclusion criteria
* Newly diagnosed with diabetes (\< 12 months) * Participant in prior preliminary work for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, 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) | Mean change in A1c per month (slope), during and post-intervention. |
| Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months) | 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. |
| Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Up to 2 time points during the intervention (12 months) and up to 2 time points in the post-intervention period (12 months) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tailored Resources Four 75-minute group-based self-management resource sessions, matched to self-management barriers identified by PRISM survey | 106 |
| Usual Care Routine multidisciplinary diabetes care | 108 |
| Total | 214 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Tailored Resources | Total | Usual Care |
|---|---|---|---|
| Age, Customized 13-16 years old | 59 Participants | 119 Participants | 60 Participants |
| Age, Customized 8-12 years old | 47 Participants | 95 Participants | 48 Participants |
| Baseline A1c | 8.9 Percent A1c STANDARD_DEVIATION 1.5 | 9.1 Percent A1c STANDARD_DEVIATION 1.6 | 9.3 Percent A1c STANDARD_DEVIATION 1.7 |
| Baseline Child Quality of Life (QOL) | 66.7 units on a scale STANDARD_DEVIATION 13.7 | 66.3 units on a scale STANDARD_DEVIATION 12.7 | 66.0 units on a scale STANDARD_DEVIATION 11.6 |
| Baseline Parent Fear of Hypoglycemia (FOH) | 38.0 units on a scale STANDARD_DEVIATION 9.6 | 38.8 units on a scale STANDARD_DEVIATION 9.9 | 39.6 units on a scale STANDARD_DEVIATION 10.3 |
| Baseline Parent Quality of Life (QOL) | 62.1 units on a scale STANDARD_DEVIATION 15.1 | 61.2 units on a scale STANDARD_DEVIATION 15.8 | 60.4 units on a scale STANDARD_DEVIATION 16.5 |
| Clinical Site Site 1 | 49 Participants | 101 Participants | 52 Participants |
| Clinical Site Site 2 | 57 Participants | 113 Participants | 56 Participants |
| Insulin pump use | 62 Participants | 110 Participants | 48 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic, White | 87 Participants | 179 Participants | 92 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Not non-Hispanic, White | 18 Participants | 34 Participants | 16 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown | 1 Participants | 1 Participants | 0 Participants |
| Relationship to child: Mother | 84 Participants | 181 Participants | 97 Participants |
| Sex: Female, Male Female | 46 Participants | 105 Participants | 59 Participants |
| Sex: Female, Male Male | 60 Participants | 109 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 106 | 0 / 108 |
| other Total, other adverse events | 0 / 106 | 0 / 108 |
| serious Total, serious adverse events | 0 / 106 | 0 / 108 |
Outcome results
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.
Time frame: Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | During Intervention | 0.194 QOL scores per month | Standard Error 0.096 |
| Usual Care | Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Post-Intervention | 0.083 QOL scores per month | Standard Error 0.155 |
| Tailored Resources | Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | During Intervention | 0.217 QOL scores per month | Standard Error 0.1 |
| Tailored Resources | Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Post-Intervention | 0.010 QOL scores per month | Standard Error 0.163 |
Comparison: During the intervention period, the treatment effect on child quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.p-value: 0.8795% CI: [-0.249, 0.295]Mixed Models Analysis
Comparison: 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.p-value: 0.7495% CI: [-0.517, 0.369]Mixed Models Analysis
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.
Time frame: Up to 5 time points during the intervention (12 months) and up to 4 time points in the post-intervention period (12 months)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | During Intervention | 0.014 Percent HbA1c per month | Standard Error 0.009 |
| Usual Care | Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Post-Intervention | 0.035 Percent HbA1c per month | Standard Error 0.008 |
| Tailored Resources | Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | During Intervention | 0.018 Percent HbA1c per month | Standard Error 0.009 |
| Tailored Resources | Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Post-Intervention | 0.025 Percent HbA1c per month | Standard Error 0.008 |
Comparison: During the intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.p-value: 0.7295% CI: [-0.021, 0.03]Mixed Models Analysis
Comparison: During the post-intervention period, the treatment effect on A1c. Results reflect the difference in A1c trend between usual care and intervention arms.p-value: 0.3895% CI: [-0.034, 0.013]Mixed Models Analysis
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.
Time frame: Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | During Intervention | 0.115 QOL scores per month | Standard Error 0.097 |
| Usual Care | Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Post-Intervention | 0.182 QOL scores per month | Standard Error 0.161 |
| Tailored Resources | Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | During Intervention | 0.078 QOL scores per month | Standard Error 0.1 |
| Tailored Resources | Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Post-Intervention | 0.172 QOL scores per month | Standard Error 0.168 |
Comparison: During the intervention period, the treatment effect on parent quality of life. Results reflect the difference in QOL trend between usual care and intervention arms.p-value: 0.7995% CI: [-0.312, 0.237]Mixed Models Analysis
Comparison: 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.p-value: 0.9795% CI: [-0.467, 0.448]Mixed Models Analysis
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.
Time frame: Up to 2 time points during the intervention (12 months) and up to 2 time points in the post-intervention period (12 months)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | During Intervention | -0.088 FOH scores per month | Standard Error 0.089 |
| Usual Care | Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Post-Intervention | -0.074 FOH scores per month | Standard Error 0.132 |
| Tailored Resources | Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | During Intervention | 0.046 FOH scores per month | Standard Error 0.093 |
| Tailored Resources | Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention | Post-Intervention | -0.080 FOH scores per month | Standard Error 0.139 |
Comparison: During the intervention period, the treatment effect on parent fear of hypoglycemia. Results reflect the difference in FOH trend between usual care and intervention arms.p-value: 0.395% CI: [-0.121, 0.388]Mixed Models Analysis
Comparison: 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.p-value: 0.9895% CI: [-0.384, 0.373]Mixed Models Analysis