Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence

NCT03557151 | Completed Results DMC

• 2 other identifiers: DP3DK1132351DP3DK113235-01
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 3

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. Other ancillary/exploratory measures are also completed.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glycosylated Hemoglobin (HbA1c)

  HbA1c expressed as percentage of glycosylated hemoglobin

  baseline (enrollment; visit 1), 3 months (start of intervention; visit 2), 6 months (visit 3), 9 months (visit 4), 12 months (end of study; visit 5)

Secondary Outcomes (2)

• Diabetes Self Management Profile-Self Report Form

  baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)

• Diabetes Self Management Profile - Parent Proxy Report

  baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)

Other Outcomes (4)

• Problem Areas in Diabetes (PAID) Scale - Adolescent Report

  Baseline (upon enrollment); 6 months; 12 months

• Problem Areas in Diabetes (PAID) Scale - Caregiver Report

  Baseline (upon enrollment); 6 months; 12 months

• Type 1 Diabetes and Life (T1DAL) - Youth Self Report

  Baseline (upon enrollment); 6 months; 12 months (end of study)

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Transdisciplinary Care-In Person & Telehealth

EXPERIMENTAL

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

Interventions

Usual Care OTHER

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.

Usual Care

Transdisciplinary Care-In Person & Telehealth BEHAVIORAL

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.

Transdisciplinary Care-In Person & Telehealth

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 16803, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Nemours Children's Hospital

Orlando, Florida, 33827, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Melissa A. Alderfer, Ph.D., Center Director & Principal Research Scientist
• Organization: Nemours Children's Hospital, Delaware

melissa.alderfer@nemours.org

302-651-6522

Study Officials

• Melissa Alderfer, PhD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Scientist and Associate Director, Center for Health Care Delivery Science

Model Details: 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).

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: July 13, 2018
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2022
• Last Updated: August 5, 2022
• Results First Posted: July 6, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (3)