Diabetes Mellitus, Type 1NCT02024750
Tailored Diabetes Self-Management Resources
A study testing Tailored Resources in people with Diabetes Mellitus, Type 1, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Tailored Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to 8 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Newly diagnosed with diabetes (< 12 months)
- Participant in prior preliminary work for this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
About this study
Official title: Family-Centered Tailoring of Pediatric Diabetes Self-Management Resources
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Tailored Resources
- Keywords
- Family centered care, Patient centered care, Diabetes Mellitus, Type 1, Problem Recognition in Illness Self-Management (PRISM)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored ResourcesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Resources | Experimental | Use of PRISM screening tool to identify self-management needs and to provide tailored group session resources over 1 year Receives: Behavioral: Tailored Resources |
| Usual Care | No intervention | Patients and families obtain routine multidisciplinary diabetes care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months)
Secondary outcomes (1)
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.
Measured: Up to 2 time points during the intervention (12 months) and up to 2 time points in the post-intervention period (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startSep 2014
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin
- Responsible party
- Sponsor
- Investigators
- Elizabeth D Cox, MD,PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024750
- Sponsor's protocol ID
- 2013-1506
- Other IDs
- MSN164403, IRB 00016300
- Status last verified
- Sep 2019
- First submitted
- 27 Dec 2013
- Last updated
- 18 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31355957Fiallo-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.
PubMed 28450194
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Centered Tailoring of Pediatric Diabetes Self-Management Resources
- ClinicalTrials.gov ID
- NCT02024750
- Acronym / sponsor ID
- 2013-1506
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Family centered care, Patient centered care, Diabetes Mellitus, Type 1, Problem Recognition in Illness Self-Management (PRISM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin
- Study start
- Sep 2014
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Posted 18 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Resources | Experimental | Behavioral: Tailored ResourcesUse 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 |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Newly diagnosed with diabetes (< 12 months)
- Participant in prior preliminary work for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored ResourcesBased 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. | Behavioural | Tailored Resources |
Primary outcome
Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, 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)
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
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)
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
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)
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.
1 secondary outcome
Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31355957Fiallo-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.
- Derived from this study: PubMed 28450194Fiallo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth D Cox, MD,PhD principal investigator
University of Wisconsin, Madison
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Resources in people with Diabetes Mellitus, Type 1, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02024750, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019; AzTrials last refreshed its copy on 28 Oct 2026.