Tailoring Resources to Help Children and Parents Manage Type 1 Diabetes

This project has results

Abstracts

Public Abstract

Download this abstract: English (pdf) | Español (pdf) | Audio Recording (mp3)

What was the research about?

About 165,000 children in the United States have type 1 diabetes. Because their bodies don’t make insulin, these children must carefully manage their blood sugar every day. Children and their parents may struggle to manage the disease and keep the child healthy.

In this study, the research team compared families who received usual diabetes care with families who got resources tailored to the families’ concerns about managing diabetes.

The research team compared how each approach helped children. They also looked at whether children’s and parents’ quality of life improved.

What were the results?

The groups didn’t differ in the children’s diabetes control or in children’s and parents’ quality of life. At one clinic, youth ages 13 to 16 who got tailored resources had better diabetes control than those who had usual care.

Who was in the study?

The study included 214 families of children ages 8 to 16 with diabetes. Of the children, 51 percent were male, 84 percent were white, 3 percent were black, 6 percent were multiple or other races, and 8 percent were Hispanic. All children were patients at one of two diabetes clinics in Wisconsin. Of the parents, 85 percent were mothers and the average age was 42.

What did the research team do?

The research team assigned families to one of two groups by chance. The first group got usual care. They met with diabetes clinic staff about every three months for a check-up and to update their care plan.

In the second group, children and their parents each took a survey that asked about concerns managing diabetes. Families in this group were invited to 75-minute group sessions that met on days when patients had clinic visits. Sessions met four times over nine months. Each session focused on specific concerns found by the survey, like the pain and bother of treatment or how families can manage care together.

In both groups, children and parents filled out surveys about their quality of life before, during, and after the study. The research team looked at children’s health records to track their blood sugar control.

Health system managers, clinicians, diabetes advocates, and children with diabetes and their parents worked with the research team to plan and conduct the study.

What were the limits of the study?

The study only included two clinics and only families that could speak or read English. Results might be different at other clinics or with families that don’t speak English. Because diabetes control improved for older children at one clinic, future research could explore whether group sessions help some patients compared with usual care.

How can people use the results?

Researchers could use results from this study to plan studies on other ways to help patients and families manage diabetes. They also could look at why the group sessions helped some patients more than usual care.

Professional Abstract

Objective

To test the effect of self-management resources, tailored to the needs of children with type 1 diabetes and their parents, on glycemic control, quality of life, and fear of hypoglycemia

Study Design

Design Element Description
Design Randomized controlled trial
Population 214 children ages 8–16 with type 1 diabetes and their parents
Interventions/
Comparators
  • Tailored self-management resources based on children and parents’ self-management barriers, plus usual care
  • Usual care
Outcomes

Primary: glycemic control, child quality of life, parent quality of life

Secondary: parent-reported fear of hypoglycemia
Timeframe 1-year follow-up for primary outcomes

Researchers conducted a randomized controlled trial to compare tailored diabetes self-management resources with usual care for children with type 1 diabetes to see how each affected children’s glycemic control and parents’ and children’s quality of life.

Children and parents in the intervention arm took the Problem Recognition in Illness Self-Management (PRISM) survey at the start of the study to identify barriers they experienced managing diabetes. Barriers included difficulties with understanding and organizing care, the pain and bother of the diabetes management regimen, denial of diabetes and its consequences, and family interactions. Research staff scheduled four group sessions during patients’ quarterly clinic visits. The sessions, delivered over nine months, focused on barriers identified in the survey. Nurses, psychologists, diabetes educators, or trained motivational interviewers provided the evidence-based self-management resources. Usual care included patients’ regular quarterly clinic visits, during which patients received testing, a physical exam, and adjustments to their insulin regimen, and discussed challenges that could affect diabetes management.

The study included 214 families with children with type 1 diabetes. Families received either tailored diabetes self-management resources or usual care at one of two diabetes clinics in Wisconsin. Of the children, 84% were white, 3% were black, and 6% were multiple or other races; 8% were Hispanic. Also, 51% were male; 56% percent were ages 13 to 16 years and the rest were 8 to 12 years. Parents’ average age was 42, and 85% were mothers.

Researchers measured children’s A1c levels and parent and child quality of life at baseline; three months after the first session; and three, six, and nine months after the intervention ended. In addition, researchers tracked parents’ worries about their children’s hypoglycemia.

Health system administrators, clinical staff, diabetes advocates, and children with diabetes and their parents worked with researchers to plan the study, develop the surveys, and provide feedback on the intervention.

Results

A1c levels did not differ significantly between the two groups overall, or during or after the intervention period. At one clinic, youth ages 13 to 16 who received tailored resources had better A1c control than those who had usual care (p=0.02) after 12 months.

Neither quality of life scores for children or parents, nor parents’ fears about their children’s hypoglycemia differed significantly between groups during or after the intervention period.

Limitations

The study only included two clinics and families that could speak or read English. Results might be different at other clinics or with non-English-speaking families. Twelve families in the intervention arm did not attend any sessions, possibly affecting study findings.

Conclusions and Relevance

Tailoring resources to address child and parent barriers to successful diabetes management did not change children’s A1c levels, child or parent quality of life, or parental worry about hypoglycemia.

Future Research Needs

Because glycemic control improved for 13- to 16-year-olds at one of the two study clinics, future research could explore further whether the intervention helps some subgroups of children with type 1 diabetes as compared with usual care.

This project's final research report is expected to be available by July 2019.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:

  • Reviewers asked what barriers prevented a substantial fraction of potential participants from joining the study. The researchers explained that the main barrier was coordination of group sessions in the diabetes clinics. They designed sessions to be tied with routine diabetes clinic appointments, but there were many more families interested in participating than there were available clinic appointments to accompany the group-based intervention. The seemingly low participation rates did not reflect families’ lack of willingness to participate and did not seem to affect how representative study participants were of the overall population.
  • Reviewers deemed the study important and well reported. Reviewers did wonder why the interventions did seem to show effects at one of the two sites but not overall. The researchers responded that they did not know what differences between sites led to greater success at one site and not the other, but they added more discussion about possible reasons for the different outcomes. These included reasons such as differences in implementation fidelity at the two sites or the possibility that teens struggle more with self-management than slightly younger children.

Study Protocol

View this project's study protocol.

Conflict of Interest Disclosures

View the COI disclosure form.

Journal Articles

Related Articles

Diabetic Medicine

The relationship of Type 1 diabetes self-management barriers to child and parent quality of life: a US cross-sectional study

Contemporary Clinical Trials

Design and baseline data from a PCORI-funded randomized controlled trial of family-centered tailoring of diabetes self-management resources.

The Diabetes Educator

Outcomes That Matter to Teens With Type 1 Diabetes

Family Practice

Patient-centred outcomes research: brave new world meets old institutional policies

More on this Project  

PCORI Stories

Does a Personalized Approach Help Young People Manage Type 1 Diabetes?
This feature story delves into the challenge that many people with type 1 diabetes face -- staying on top of blood sugar levels is of utmost importance for -- and it looks at whether group-based self-management resources tailored to specific needs can help children and teens.

Videos

Helping Families Manage Type 1 Diabetes in Adolescents
Principal investigator Elizabeth Cox, MD, PhD talks about what prompted her to pursue research that's long-term goal is to provide families with the best help for managing diabetes.

Project Details

Principal Investigator
Elizabeth D. Cox, MD, PhD
Project Status
Completed; PCORI Public and Professional Abstracts Posted
Project Title
Family-Centered Tailoring of Pediatric Diabetes Self-Management Resources
Board Approval Date
September 2013
Project End Date
December 2018
Organization
University of Wisconsin-Madison
Year Awarded
2013
State
Wisconsin
Year Completed
2018
Project Type
Research Project
Funding Announcement
Improving Healthcare Systems
Conditions 
Nutritional and Metabolic Disorders
Diabetes
Respiratory Diseases
Asthma
Project Budget
$2,150,963
Study Registration Information
HSRP20143552
NCT02024750
Page Last Updated: 
November 19, 2018