Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03557151

Recruitment Status : Active, not recruiting

First Posted : June 14, 2018

Last Update Posted : September 20, 2021

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

Melissa Alderfer, Nemours Children's Clinic

Study Description

Brief Summary:

This study will consist of a randomized controlled trial to test a novel Transdisciplinary Care (TC) model of delivery of care for type 1 diabetes in adolescence. Adolescents and their parents/caregivers (n=150) will be randomized to Usual Care or TC care in a 1:2 ratio. Approximately half of those in TC care will received TC in person and half will receive it through telehealth. TC visits will consist of conjoint management of T1D by a TC team consisting of an Advanced Practice Nurse, Dietitian and Psychologist who will see parent-adolescent dyads together within the same visit. TC team members have trained each other in their respective disciplines. Outcome measures include glycohemoglobin (HbA1c) and questionnaires assessing diabetes self management behaviors and adolescent and parent coping with T1D and its treatment.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes Mellitus	Other: Usual Care Behavioral: Transdisciplinary Care-In Person & Telehealth	Not Applicable

Show detailed description

Detailed Description:

Large epidemiologic studies show that <25% of adolescents with type 1 diabetes (T1D) achieve targeted glycohemoglobin levels advocated by the American Diabetes Association (< 7.5%) or International Society of Pediatric and Adolescent Diabetes (< 7.0%). Optimal self-management of T1D requires daily insulin replacement by multiple injections or insulin pump, 4-6 daily blood glucose checks, regulation of carbohydrate intake and physical activity, prevention/correction of glycemic fluctuations and perhaps use of a continuous glucose monitor. This regimen places pervasive affective, behavioral, cognitive and social demands on adolescents with T1D and their families and psychosocial variables greatly impact their success in T1D self-care. Struggling with maintaining adequate glycemic control is essentially normative among adolescents, suggesting that conventional systems of care are not meeting the needs of this population. A substantial, growing literature provides an evidence base for psychosocial screening and behavioral intervention strategies targeting improved coping with the demands of T1D, but this evidence base has not penetrated fully into routine T1D care. Rigorous integration of this evidence into routine care for T1D could yield many benefits. Behavioral barriers to effective care are major concerns of all stakeholders, but conventional care is not well-equipped to address these issues. Concomitantly, the supply of board-certified pediatric endocrinologists is not keeping pace with growth of the T1D patient population, amplifying the need to validate alternative delivery systems that multiply the effective workforce of T1D health professionals. We will develop and test a novel Transdisciplinary Care (TC) approach (conjoint TC visits conducted by an Advanced Practice Nurse, Psychology Postdoctoral Fellow and Dietitian) to improve adolescents' T1D outcomes and justify a larger randomized controlled trial (RCT). In Year 1, crowdsourcing methods will engage youths with T1D, parents and health care providers (HCP) in planning a feasible, acceptable, safe and effective TC model that addresses youths' and families' psychosocial needs and capitalizes on the expertise of advanced practice nurses co-managing T1D with psychologists and dietitians. The Wallander et al. stress and coping model and the D'Zurilla and Goldfried problem solving model provide a sound conceptual framework for the TC model of care. The TC team will learn each discipline's skills in T1D management, develop a detailed TC manual to guide this work and others' future studies, see adolescents and parents together as a team, screen for potentially modifiable psychological impediments to T1D care, and promote families' coping resources by enhancing family-centered communication and problem solving, implementing empirically validated behavioral interventions and facilitating additional appropriate services for complex problems. Telehealth delivery of TC care carries several potential advantages, justifying its inclusion within a RCT comparing the effects of UC to TC delivered via various modalities on glycemic control and treatment adherence (primary outcomes) as well as quality of life and other psychosocial variables (secondary outcomes). Qualitative and economic analyses will follow the RCT, providing perspectives on mechanisms of TC effects and its sustainability. Mixed qualitative and quantitative methods will validate an innovative model of T1D care for adolescents that could then be tested in a future definitive, multi-site RCT.

We will address these specific aims:

SPECIFIC AIM 1. In Year 1, with methods used effectively in our ongoing DP3 study of parents of children <6 years old with T1D, we will engage separate "crowds" of adolescents with T1D, parents, and HCPs in planning/refining a feasible, safe, acceptable and efficacious Trans-Disciplinary care model (TC) for T1D in adolescence. This crowdsourcing effort should yield a TC model that meets the needs of all key stakeholder groups, ensuring its feasibility, acceptance and efficacy.

SPECIFIC AIM 2. With study oversight by a diverse stakeholder panel and guided by a detailed intervention manual, 150 families of adolescents treated for T1D at Nemours practices in the Delaware Valley or Florida will participate in a rigorous Randomized Controlled Trial (RCT) in years 2 and 3. The RCT will compare Usual Care (UC) with Trans-Disciplinary Care on glycohemoglobin (HbA1C), treatment adherence, health care use, T1D-related distress, quality of life, and treatment satisfaction. Delivery mode of Trans-Disciplinary Care will also be explored (e.g., Face-to-Face, Telehealth, Combined). The proposed trial will yield substantial information that could justify a definitive future test of this model, inform methodological planning for subsequent studies, and explore whether certain modes of delivery (e.g., Telehealth) are justified for evaluation in future trials.

SPECIFIC AIM 3. Qualitative interviews of adolescents, parents, and health care providers completed at the midpoint and end of the RCT will identify possible mediators or moderators of TC efficacy and guide refinements to the TC model. We will interview third party payers about the feasibility of dissemination of the TC model into practice and collect health care cost data. These analyses will strengthen the justification for a future, larger trial of TC, and guide refinements to the TC model to further enhance its efficacy.

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	115 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	The study design randomizes participants to standard care or transdisciplinary care delivered through various modalities (in person; telehealth). Data collection occurs at 5 Time Points (0, 3, 6, 9 and 12 months).
Masking:	Single (Outcomes Assessor)
Masking Description:	Persons completing data scoring and entry tasks will be kept blinded to a given participant's treatment assignment. Most scoring is automated via the REDCap platform.
Primary Purpose:	Treatment
Official Title:	Transdisciplinary Versus Usual Care for Type 1 Diabetes in Adolescence
Actual Study Start Date :	July 13, 2018
Actual Primary Completion Date :	March 31, 2021
Estimated Study Completion Date :	March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Usual Care Usual Care participants will receive the same excellent multidisciplinary care they would receive at the same center were they not enrolled in the trial. In clinic visits scheduled at approximately 3-month intervals, they will see subspecialty board certified or eligible pediatric endocrinologists, supplemented as needed with involvement of certified diabetes educators, dietitians, social workers or psychologists. HbA1c target is < 7.5% with no severe hypoglycemia and acceptable quality of life. About half are expected to be on insulin pumps and carbohydrate counting, while the great majority of others are following basal-bolus multiple daily injection regimens, also based on carbohydrate counting. A rising proportion of patients use continuous glucose monitors and this trend is likely to accelerate during the study.	Other: Usual Care Usual Care participants will receive the same excellent multidisciplinary Care they would receive at the same center were they not enrolled in the trial. In clinic visits scheduled at approximately 3-month intervals, they will see subspecialty board certified or eligible pediatric endocrinologists, supplemented as needed with involvement of certified diabetes educators, dietitians, social workers or psychologists. HbA1c target is < 7.5% with no severe hypoglycemia and acceptable quality of life. About half are expected to be on insulin pumps and carbohydrate counting, while the great majority of others are following basal-bolus multiple daily injection regimens, also based on carbohydrate counting. A rising proportion of patients use continuous glucose monitors and this trend is likely to accelerate during the study.
Experimental: Transdisciplinary Care-In Person & Telehealth In addition to all elements of Usual Care, TC-IP participants will have follow-up clinic visits in-person or by telehealth at approximately 3 month intervals during the study that will consist of simultaneous involvement of an advanced practice nurse, dietitian and psychologist who will see the parent and adolescent together. TC team members will have passed a competency exam following completion of a training course on each of the TC team professional disciplines.	Behavioral: Transdisciplinary Care-In Person & Telehealth TC participants will receive all elements of the Usual Care intervention but they will do so in the context of face to face or telehealth delivery of TC follow-up visits with simultaneous involvement of an advanced practice nurse, dietitian and psychologist at each visit.

Arm

Intervention/treatment

Active Comparator: Usual Care

Usual Care participants will receive the same excellent multidisciplinary care they would receive at the same center were they not enrolled in the trial. In clinic visits scheduled at approximately 3-month intervals, they will see subspecialty board certified or eligible pediatric endocrinologists, supplemented as needed with involvement of certified diabetes educators, dietitians, social workers or psychologists. HbA1c target is < 7.5% with no severe hypoglycemia and acceptable quality of life. About half are expected to be on insulin pumps and carbohydrate counting, while the great majority of others are following basal-bolus multiple daily injection regimens, also based on carbohydrate counting. A rising proportion of patients use continuous glucose monitors and this trend is likely to accelerate during the study.

Other: Usual Care

Usual Care participants will receive the same excellent multidisciplinary Care they would receive at the same center were they not enrolled in the trial. In clinic visits scheduled at approximately 3-month intervals, they will see subspecialty board certified or eligible pediatric endocrinologists, supplemented as needed with involvement of certified diabetes educators, dietitians, social workers or psychologists. HbA1c target is < 7.5% with no severe hypoglycemia and acceptable quality of life. About half are expected to be on insulin pumps and carbohydrate counting, while the great majority of others are following basal-bolus multiple daily injection regimens, also based on carbohydrate counting. A rising proportion of patients use continuous glucose monitors and this trend is likely to accelerate during the study.

Experimental: Transdisciplinary Care-In Person & Telehealth

In addition to all elements of Usual Care, TC-IP participants will have follow-up clinic visits in-person or by telehealth at approximately 3 month intervals during the study that will consist of simultaneous involvement of an advanced practice nurse, dietitian and psychologist who will see the parent and adolescent together. TC team members will have passed a competency exam following completion of a training course on each of the TC team professional disciplines.

Behavioral: Transdisciplinary Care-In Person & Telehealth

TC participants will receive all elements of the Usual Care intervention but they will do so in the context of face to face or telehealth delivery of TC follow-up visits with simultaneous involvement of an advanced practice nurse, dietitian and psychologist at each visit.

Outcome Measures

Primary Outcome Measures :

Glycosylated hemoglobin (HbA1c) [ Time Frame: 3-months ]
HbA1c expressed as % of red cells bound to glucose

Secondary Outcome Measures :

Diabetes Self Management Profile-Self Report Form [ Time Frame: 3 months ]
Adherence Measure
Problem Areas in Diabetes Scale-Adolescent and Parent Versions [ Time Frame: 3 months ]
Diabetes coping measure
Hilliard Quality of Life Scales [ Time Frame: 3 months ]
QOL measure

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	11 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Adolescents:

Age > 11 years but < 17 years at time of consent
Diagnosis of Type 1 diabetes with duration of > 1 year
Most recent HbA1C or mean HbA1C over the prior year 7.5-10.0%, inclusive
Has had at least one clinic visit for T1D at a Nemours Children's Clinic within the past year
Is not currently participating in any other research in which treatment adherence or glycemic control are study outcomes
No T1D clinic visits in the preceding 12 months in which two or more care providers saw the patient together
Is not on daily oral glucocorticoid treatment
Is considered developmentally normal by the treating clinician (not in a self- contained special education classroom or been retained in 2 or more grades)
Is able to read/comprehend study questionnaires in English
Is not currently undergoing treatment for a coincident medical condition that, in the opinion of the treating physician, represents a contraindication to study participation
Family must be able to access the internet

Parents:

Is either a biological parent or legally appointed caregiver of the child
Is the primary diabetes caregiver of the child: and at least weekly involvement in T1D care
Routinely accompanies child for diabetes care at Nemours
Is willing to schedule T1D clinic visits at a specific available location in Orlando or Wilmington
Capable of participating in conversations in English during medical visits
Anticipates continued medical care for T1D at Nemours for a year following study enrollment
Is able to read/comprehend study questionnaires and decision aids in English
Does not have an open abuse/neglect case with any child protection agency over the prior 3 years
There is no evidence of frequent changes in the adolescent's household or living arrangements

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557151

Locations

Layout table for location information

United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 16803
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Nemours Children's Hospital
Orlando, Florida, United States, 33827

Sponsors and Collaborators

Nemours Children's Clinic

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Layout table for investigator information

Principal Investigator:	Melissa Alderfer, PhD	Nemours Children's Clinic

Study Documents (Full-Text)

Documents provided by Melissa Alderfer, Nemours Children's Clinic:

Study Protocol and Statistical Analysis Plan [PDF] June 26, 2020

More Information

Layout table for additonal information

Responsible Party:	Melissa Alderfer, Principal Research Scientist and Associate Director, Center for Health Care Delivery Science, Nemours Children's Clinic
ClinicalTrials.gov Identifier:	NCT03557151
Other Study ID Numbers:	DP3DK113235 ( U.S. NIH Grant/Contract ) 1DP3DK113235-01 ( U.S. NIH Grant/Contract )
First Posted:	June 14, 2018 Key Record Dates
Last Update Posted:	September 20, 2021
Last Verified:	September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	A redacted data set stripped of all HIPAA-defined identifiers will be made available to interested and qualified researchers once all of the analyses of the study hypotheses have been completed and published. Access will require negotiation of a satisfactory Data Use Agreement between the Nemours Foundation and the interested party(ies).
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Analytic Code
Time Frame:	Once analyses of primary study hypotheses have been completed and published, the de-identified data set will be available for 5 years.
Access Criteria:	Contact the PI with a data use request and initiate a Data Use Agreement if the request is deemed to be feasible.

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases	Endocrine System Diseases Autoimmune Diseases Immune System Diseases

To Top