Clinical trial NCT03557151: Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence
Official title: Transdisciplinary Versus Usual Care for Type 1 Diabetes in Adolescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-06-14
Enrollment: 230
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Glycosylated Hemoglobin (HbA1c)
timeFrame: 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:
measure: Diabetes Self Management Profile-Self Report Form
timeFrame: baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)
measure: Diabetes Self Management Profile - Parent Proxy Report
timeFrame: baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)
Other outcomes:
measure: Problem Areas in Diabetes (PAID) Scale - Adolescent Report
timeFrame: Baseline (upon enrollment); 6 months; 12 months
measure: Problem Areas in Diabetes (PAID) Scale - Caregiver Report
timeFrame: Baseline (upon enrollment); 6 months; 12 months
measure: Type 1 Diabetes and Life (T1DAL) - Youth Self Report
timeFrame: Baseline (upon enrollment); 6 months; 12 months (end of study)
measure: Type 1 Diabetes and Life (T1DAL) Scale - Caregiver Report
timeFrame: Baseline (upon enrollment); 6 months; 12 months (end of study)
Locations:
city: Wilmington
country: United States
facility: Alfred I. duPont Hospital for Children
state: Delaware
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Melissa Alderfer, PhD
role: PRINCIPAL_INVESTIGATOR
References: