Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence

• Sponsor: Nemours Children's Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03557151
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 230
• Locations: 3
• Arms: 2
• Actual Duration (Months): 44.6
• Patients Per Site: 76.7
• Patients Per Site Per Month: 1.7

Study Details

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. Other ancillary/exploratory measures are also completed.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Other: Usual Care; Behavioral: Transdisciplinary Care-In Person & Telehealth	N/A

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 (exploratory 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, along with exploratory outcomes including 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

• Study Type: Interventional
• Actual Enrollment: 230 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).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: Jul 13, 2018
• Actual Primary Completion Date: Mar 31, 2021
• Actual Study Completion Date: Mar 31, 2022

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.

Outcome Measures

Primary Outcome Measures

1. Glycosylated Hemoglobin (HbA1c) [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)]

   HbA1c expressed as percentage of glycosylated hemoglobin

Secondary Outcome Measures

1. Diabetes Self Management Profile-Self Report Form [baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)]

   This 24 item measure assesses self-care behaviors that typify current T1D care. It is completed by the adolescent with T1D. Total scores are being used and range from 0 to 84 with higher scores indicating better adherence. In previous work, the scale had an internal consistency coefficient of .79 and a mean correlation of .48 with HbA1C.

2. Diabetes Self Management Profile - Parent Proxy Report [baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)]

   This 24 item parent-report measure parallels the youth self report measure and assesses self-care behaviors that typify current T1D care. The total scores is being reported with possible scores ranging from 0 to 84. Higher scores indicate better adherence to T1D care. In past work parent and youth reports have correlated at .63.

Other Outcome Measures

1. Problem Areas in Diabetes (PAID) Scale - Adolescent Report [Baseline (upon enrollment); 6 months; 12 months]

   This 14 item brief version of the scale measures problems, hassles, and distress related to diabetes and diabetes care. Respondents rate each item on a Likert-type scale ranging from 1 (not a problem) to 6 (serious problems). Scores range from 14 to 84 with higher scores indicating more diabetes-related problems.

2. Problem Areas in Diabetes (PAID) Scale - Caregiver Report [Baseline (upon enrollment); 6 months; 12 months]

   This 15 item brief version of the scale measures problems, hassles, and distress related to diabetes and diabetes care. Respondents rate each item on a Likert-type scale ranging from 1 (not a problem) to 6 (serious problems). Scores range from 15 to 90 with higher scores indicating more diabetes-related problems.

3. Type 1 Diabetes and Life (T1DAL) - Youth Self Report [Baseline (upon enrollment); 6 months; 12 months (end of study)]

   This measure assesses the adolescent's diabetes-related quality of life. Raw scores are converted to standardized scores that can range from 1 to 100. Higher scores indicate greater quality of life.

4. Type 1 Diabetes and Life (T1DAL) Scale - Caregiver Report [Baseline (upon enrollment); 6 months; 12 months (end of study)]

   This caregiver-report measure assesses caregiver quality of life related to their child's diabetes. Raw scores are standardized to range from 0 to 100 with higher scores indicating better quality of life.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 11 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Alfred I. duPont Hospital for Children	Wilmington	Delaware	United States	16803
2	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
3	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

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 26, 2020

More Information

Publications

None provided.

• 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; 1DP3DK113235-01
• First Posted: Jun 14, 2018
• Last Update Posted: Aug 5, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

Participant Flow

Recruitment Details	Adolescents with T1D and their caregiver were recruited and randomized as a dyad. 115 dyads (families) enrolled in the study
Pre-assignment Detail	After enrollment, participants were required to complete baseline measures prior to randomization. A total of 11 families (22 participants) did not complete baseline measures and were not randomized to condition.

Arm/Group Title	Usual Care	Transdisciplinary Care (In Person or Telehealth)
Arm/Group Description	Usual Care includes the multidisciplinary health care, education and supports that are routinely available to Nemours families of youth with T1D. This includes clinic visits approximately every 3 months with a pediatric endocrinologist or advanced practice nurse, with referrals to a certified diabetes educator, dietitian, social worker or psychologist as deemed clinically necessary by that HCP.	Transdisciplinary Care includes all elements of Usual Care, but quarterly T1D visits are co-managed by an APN, RD and a Psychologist who provide care to the adolescent and parent(s) as a team during each visit. A central TC feature is active incorporation of evidence-based psychosocial care for T1D into visits including motivational interviewing techniques, systematic problem solving, and the facilitation of family communication to address each family's self-identified T1D challenges. TC visits will include interaction with all three team members jointly, with subsequent interaction between the parent/youth or both with a subset of this team as decided by family and team consensus during the visit.
Period Title: Randomization to 3 Months
STARTED	74	134
Adolescent Participants	37	67
Caregiver Participants	37	67
COMPLETED	72	132
NOT COMPLETED	2	2
Period Title: Randomization to 3 Months
STARTED	72	132
Adolescent Participants	36	66
Caregiver Participants	36	66
COMPLETED	72	132
NOT COMPLETED	0	0
Period Title: Randomization to 3 Months
STARTED	72	132
Adolescent Participants	36	66
Caregiver Participants	36	66
COMPLETED	70	132
NOT COMPLETED	2	0
Period Title: Randomization to 3 Months
STARTED	70	132
Adolescent Participants	35	66
Caregiver Participants	35	66
COMPLETED	70	130
NOT COMPLETED	0	2

Baseline Characteristics

Arm/Group Title	Usual Care	Transdisciplinary Care (In Person or Telehealth)	Total
Arm/Group Description	Usual Care includes the multidisciplinary health care, education and supports that are routinely available to Nemours families of youth with T1D. This includes clinic visits approximately every 3 months with a pediatric endocrinologist or advanced practice nurse, with referrals to a certified diabetes educator, dietitian, social worker or psychologist as deemed clinically necessary by that HCP.	Transdisciplinary Care includes all elements of Usual Care, but quarterly T1D visits are co-managed by an APN, RD and a Psychologist who provide care to the adolescent and parent(s) as a team during each visit. A central TC feature is active incorporation of evidence-based psychosocial care for T1D into visits including motivational interviewing techniques, systematic problem solving, and the facilitation of family communication to address each family's self-identified T1D challenges. TC visits will include interaction with all three team members jointly, with subsequent interaction between the parent/youth or both with a subset of this team as decided by family and team consensus during the visit.	Total of all reporting groups
Overall Participants	74	134	208
Age (years) [Mean (Standard Deviation) ]
Adolescents	13.88 (1.77)	14.07 (1.74)	14.01 (1.75)
Caregivers of adolescents	42.61 (6.89)	42.98 (7.06)	42.85 (6.97)
Sex: Female, Male (Count of Participants)
Female	19 25.7%	36 26.9%	55 26.4%
Male	18 24.3%	31 23.1%	49 23.6%
Female	33 44.6%	58 43.3%	91 43.8%
Male	4 5.4%	8 6%	12 5.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 10.8%	11 8.2%	19 9.1%
Not Hispanic or Latino	29 39.2%	54 40.3%	83 39.9%
Unknown or Not Reported	0 0%	2 1.5%	2 1%
Hispanic or Latino	6 8.1%	11 8.2%	17 8.2%
Not Hispanic or Latino	31 41.9%	55 41%	86 41.3%
Unknown or Not Reported	0 0%	1 0.7%	1 0.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.4%	0 0%	1 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 6.8%	13 9.7%	18 8.7%
White	23 31.1%	43 32.1%	66 31.7%
More than one race	5 6.8%	7 5.2%	12 5.8%
Unknown or Not Reported	3 4.1%	4 3%	7 3.4%
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 6.8%	13 9.7%	18 8.7%
White	26 35.1%	43 32.1%	69 33.2%
More than one race	1 1.4%	6 4.5%	7 3.4%
Unknown or Not Reported	5 6.8%	5 3.7%	10 4.8%
HbA1c (percentage glycosylated hemoglobin) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage glycosylated hemoglobin]	8.52 (1.19)	8.87 (1.26)	8.74 (1.24)
Diabetes Self Management Profile - Youth Self Report (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	53.87 (12.33)	52.37 (11.39)	52.92 (11.70)
Diabetes Self Management Profile - Parent Proxy Report (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	55.20 (12.1)	53.68 (11.97)	54.23 (11.98)

Outcome Measures

1. Primary Outcome

Title	Glycosylated Hemoglobin (HbA1c)
Description	HbA1c expressed as percentage of glycosylated hemoglobin
Time Frame	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)

Outcome Measure Data

Analysis Population Description

These values are derived from blood work on the adolescent patients and represent all available raw data. HbA1c data were not available at all timepoints due to missed clinical visits and/or unreturned blood spot kits.

Arm/Group Title	Usual Care	Transdisciplinary Care (In Person or Telehealth)
Arm/Group Description	Usual Care includes the multidisciplinary health care, education and supports that are routinely available to Nemours families of youth with T1D. This includes clinic visits approximately every 3 months with a pediatric endocrinologist or advanced practice nurse, with referrals to a certified diabetes educator, dietitian, social worker or psychologist as deemed clinically necessary by that HCP.	Transdisciplinary Care includes all elements of Usual Care, but quarterly T1D visits are co-managed by an APN, RD and a Psychologist who provide care to the adolescent and parent(s) as a team during each visit. A central TC feature is active incorporation of evidence-based psychosocial care for T1D into visits including motivational interviewing techniques, systematic problem solving, and the facilitation of family communication to address each family's self-identified T1D challenges. TC visits will include interaction with all three team members jointly, with subsequent interaction between the parent/youth or both with a subset of this team as decided by family and team consensus during the visit.
Measure Participants	37	67
3 months	8.59 (1.56)	9.02 (1.50)
6 months	8.71 (1.41)	9.03 (1.58)
9 months	8.59 (1.66)	8.98 (1.27)
12 months	8.45 (1.21)	8.97 (1.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Transdisciplinary Care (In Person or Telehealth)
	Comments	Transdisciplinary Care is being compared to Usual Care using the Time 2 HbA1c (as baseline) and Time 5 HbA1c (as the outcome) controlling for race/ethnicity, gender, and age of the patient. The interaction of condition and time is used to evaluate the treatment effect. Missing data were not imputed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.895
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 95%; -0.68 to 0.60
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.33
	Estimation Comments

2. Secondary Outcome

Title	Diabetes Self Management Profile-Self Report Form
Description	This 24 item measure assesses self-care behaviors that typify current T1D care. It is completed by the adolescent with T1D. Total scores are being used and range from 0 to 84 with higher scores indicating better adherence. In previous work, the scale had an internal consistency coefficient of .79 and a mean correlation of .48 with HbA1C.
Time Frame	baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)

Outcome Measure Data

Analysis Population Description

These are raw data from all adolescent participants providing data. Decrements in the number of participants are due to missing data.

Arm/Group Title	Usual Care	Transdisciplinary Care (In Person or Telehealth)
Arm/Group Description	Usual Care includes the multidisciplinary health care, education and supports that are routinely available to Nemours families of youth with T1D. This includes clinic visits approximately every 3 months with a pediatric endocrinologist or advanced practice nurse, with referrals to a certified diabetes educator, dietitian, social worker or psychologist as deemed clinically necessary by that HCP.	Transdisciplinary Care includes all elements of Usual Care, but quarterly T1D visits are co-managed by an APN, RD and a Psychologist who provide care to the adolescent and parent(s) as a team during each visit. A central TC feature is active incorporation of evidence-based psychosocial care for T1D into visits including motivational interviewing techniques, systematic problem solving, and the facilitation of family communication to address each family's self-identified T1D challenges. TC visits will include interaction with all three team members jointly, with subsequent interaction between the parent/youth or both with a subset of this team as decided by family and team consensus during the visit.
Measure Participants	37	67
6 month assessment	53.45 (11.55)	55.99 (11.86)
12 month assessment	53.97 (10.61)	55.09 (12.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Transdisciplinary Care (In Person or Telehealth)
	Comments	TC is being compared to UC using baseline and 12 month data, controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to examine the treatment effect. Missing data were not imputed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.33
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	2.29
	Confidence Interval	(2-Sided) 95%; -2.29 to 6.88
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.34
	Estimation Comments

3. Secondary Outcome

Title	Diabetes Self Management Profile - Parent Proxy Report
Description	This 24 item parent-report measure parallels the youth self report measure and assesses self-care behaviors that typify current T1D care. The total scores is being reported with possible scores ranging from 0 to 84. Higher scores indicate better adherence to T1D care. In past work parent and youth reports have correlated at .63.
Time Frame	baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)

Outcome Measure Data

Analysis Population Description

These are raw data. Discrepancies in participant numbers are due to missing data.

Arm/Group Title	Usual Care	Transdisciplinary Care (In Person or Telehealth)
Arm/Group Description	Usual Care includes the multidisciplinary health care, education and supports that are routinely available to Nemours families of youth with T1D. This includes clinic visits approximately every 3 months with a pediatric endocrinologist or advanced practice nurse, with referrals to a certified diabetes educator, dietitian, social worker or psychologist as deemed clinically necessary by that HCP.	Transdisciplinary Care includes all elements of Usual Care, but quarterly T1D visits are co-managed by an APN, RD and a Psychologist who provide care to the adolescent and parent(s) as a team during each visit. A central TC feature is active incorporation of evidence-based psychosocial care for T1D into visits including motivational interviewing techniques, systematic problem solving, and the facilitation of family communication to address each family's self-identified T1D challenges. TC visits will include interaction with all three team members jointly, with subsequent interaction between the parent/youth or both with a subset of this team as decided by family and team consensus during the visit.
Measure Participants	37	67
6 month assessment	53.73 (11.39)	54.44 (12.27)
12 month assessment	52.67 (14.40)	55.64 (13.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Transdisciplinary Care (In Person or Telehealth)
	Comments	TC is being compared to UC using baseline and 12 month data and controlling for patient age, sex, and race/ethnicity. The interaction between condition and time is used to evaluate the treatment effect. Missing data are not imputed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.07
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	4.1
	Confidence Interval	(2-Sided) 95%; -.32 to 8.53
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.25
	Estimation Comments

4. Other Pre-specified Outcome

Title	Problem Areas in Diabetes (PAID) Scale - Adolescent Report
Description	This 14 item brief version of the scale measures problems, hassles, and distress related to diabetes and diabetes care. Respondents rate each item on a Likert-type scale ranging from 1 (not a problem) to 6 (serious problems). Scores range from 14 to 84 with higher scores indicating more diabetes-related problems.
Time Frame	Baseline (upon enrollment); 6 months; 12 months

Outcome Measure Data

Analysis Population Description

This adolescent-report measure was only completed by the adolescents taking part in the study (not caregivers). The data reported below are raw data (not imputed) and the discrepancies in the number of subjects are due to missing data.

Arm/Group Title	Usual Care	Transdisciplinary Care-In Person & Telehealth
Arm/Group Description	Usual Care participants 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.	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. 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.
Measure Participants	37	66
Baseline	38.73 (16.88)	35.62 (16.45)
6 months	39.57 (15.01)	30.12 (13.97)
12 months (end of study)	37.12 (17.16)	30.55 (16.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Transdisciplinary Care (In Person or Telehealth)
	Comments	This analysis included baseline and 12-month data. The interaction of condition (TC or UC) and time was used to examine the treatment effect. Child sex, age, and race/ethnicity were covariates. Missing data were not imputed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.527
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-2.38
	Confidence Interval	(2-Sided) 95%; -9.77 to 5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.77
	Estimation Comments

5. Other Pre-specified Outcome

Title	Problem Areas in Diabetes (PAID) Scale - Caregiver Report
Description	This 15 item brief version of the scale measures problems, hassles, and distress related to diabetes and diabetes care. Respondents rate each item on a Likert-type scale ranging from 1 (not a problem) to 6 (serious problems). Scores range from 15 to 90 with higher scores indicating more diabetes-related problems.
Time Frame	Baseline (upon enrollment); 6 months; 12 months

Outcome Measure Data

Analysis Population Description

This caregiver-report measure was completed only by the caregiver participants in the study. Raw data are reported. Any deviations from the expected number of subjects is due to missing data.

Arm/Group Title	Usual Care	Transdisciplinary Care-In Person & Telehealth
Arm/Group Description	Usual Care participants 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.	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. 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.
Measure Participants	37	66
Baseline	52.85 (17.40)	44.92 (19.73)
6 months	54.42 (17.10)	43.24 (19.44)
12 months	53.46 (15.91)	42.15 (18.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Transdisciplinary Care (In Person or Telehealth)
	Comments	This analysis uses baseline and 12 month data. The interaction of condition and time is used to evaluate the treatment effect. Child sex, age, and race/ethnicity were used as covariates. Missing data were not imputed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.253
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-3.30
	Confidence Interval	(2-Sided) 95%; -8.94 to 2.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.89
	Estimation Comments

6. Other Pre-specified Outcome

Title	Type 1 Diabetes and Life (T1DAL) - Youth Self Report
Description	This measure assesses the adolescent's diabetes-related quality of life. Raw scores are converted to standardized scores that can range from 1 to 100. Higher scores indicate greater quality of life.
Time Frame	Baseline (upon enrollment); 6 months; 12 months (end of study)

Outcome Measure Data

Analysis Population Description

This youth-report measure was completed only by adolescent participants. Raw data are reported below. Any deviations in sample size are due to missing data.

Arm/Group Title	Usual Care	Transdisciplinary Care-In Person & Telehealth
Arm/Group Description	Usual Care participants 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.	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. 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.
Measure Participants	36	66
Baseline	61.84 (16.62)	61.46 (18.21)
6 months	57.85 (15.81)	67.76 (18.74)
12 months	57.76 (17.04)	67.66 (19.71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Transdisciplinary Care (In Person or Telehealth)
	Comments	This analysis included baseline and 12 month data. The condition by time interaction was used to evaluate the treatment effect. Child age, sex, and race/ethnicity were included as covariates. Missing data were not imputed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	9.69
	Confidence Interval	(2-Sided) 95%; 2.31 to 17.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.77
	Estimation Comments

7. Other Pre-specified Outcome

Title	Type 1 Diabetes and Life (T1DAL) Scale - Caregiver Report
Description	This caregiver-report measure assesses caregiver quality of life related to their child's diabetes. Raw scores are standardized to range from 0 to 100 with higher scores indicating better quality of life.
Time Frame	Baseline (upon enrollment); 6 months; 12 months (end of study)

Outcome Measure Data

Analysis Population Description

This caregiver-report measure was only completed by caregiver participants. Raw data is presented. Any deviations in the number of subjects across time points is due to missing data.

Arm/Group Title	Usual Care	Transdisciplinary Care-In Person & Telehealth
Arm/Group Description	Usual Care participants 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.	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. 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.
Measure Participants	37	66
Baseline	55.97 (11.50)	65.64 (14.74)
6 months	56.62 (10.10)	66.73 (14.54)
12 months	55.36 (11.20)	66.32 (15.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Usual Care, Transdisciplinary Care (In Person or Telehealth)
	Comments	This analysis uses baseline and 12-month data. The interaction between condition and time is used to evaluate the treatment effect. Child age, sex, and race/ethnicity were covariates. Missing data were not imputed.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.83
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	.45
	Confidence Interval	(2-Sided) 95%; -3.62 to 4.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.07
	Estimation Comments

Adverse Events

Time Frame	Approximately 1 year. Adverse events (AEs) were recorded for adolescent participants from the time of randomization through final study visit or close of final study visit time window. AEs were not collected regarding caregivers. Of note, the report of AEs for those randomized to Transdisciplinary Care (TC) includes the 3 month time period AFTER randomization but PRIOR to receiving the intervention. It also includes 6 participants who were randomized to but never attended a TC visit.
Adverse Event Reporting Description	ClinicalTrials.gov definitions are being used. Serious Adverse Events include hospitalizations for any reason and emergency room visits related to diabetes care.
Arm/Group Title	Usual Care		Transdisciplinary Care (In Person or Telehealth)
Arm/Group Description	Usual Care includes the multidisciplinary health care, education and supports that are routinely available to Nemours families of youth with T1D. This includes clinic visits approximately every 3 months with a pediatric endocrinologist or advanced practice nurse, with referrals to a certified diabetes educator, dietitian, social worker or psychologist as deemed clinically necessary by that HCP.		Transdisciplinary Care includes all elements of Usual Care, but quarterly T1D visits are co-managed by an APN, RD and a Psychologist who provide care to the adolescent and parent(s) as a team during each visit. A central TC feature is active incorporation of evidence-based psychosocial care for T1D into visits including motivational interviewing techniques, systematic problem solving, and the facilitation of family communication to address each family's self-identified T1D challenges. TC visits will include interaction with all three team members jointly, with subsequent interaction between the parent/youth or both with a subset of this team as decided by family and team consensus during the visit.
All Cause Mortality
	Usual Care		Transdisciplinary Care (In Person or Telehealth)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/67 (0%)
Serious Adverse Events
	Usual Care		Transdisciplinary Care (In Person or Telehealth)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/37 (8.1%)		7/67 (10.4%)
Endocrine disorders
Inpatient Hospitalization related to diabetes	1/37 (2.7%)	1	3/67 (4.5%)	3
Emergency Room visit related to diabetes	1/37 (2.7%)	1	6/67 (9%)	8
General disorders
Inpatient Hospitalization unrelated to diabetes	1/37 (2.7%)	1	1/67 (1.5%)	1
Other (Not Including Serious) Adverse Events
	Usual Care		Transdisciplinary Care (In Person or Telehealth)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/37 (48.6%)		26/67 (38.8%)
Endocrine disorders
Increase of 1.5% or more in HbA1c from one data point to another during study participation	7/37 (18.9%)	14	19/67 (28.4%)	28
General disorders
Decrease in QoL of 1.5SD or more	8/37 (21.6%)	8	7/67 (10.4%)	8
Surgical and medical procedures
Gap in clinical care of 6 months or more	8/37 (21.6%)	9	5/67 (7.5%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.