Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Transdisciplinary Versus Usual Care for Type 1 Diabetes in Adolescence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557151
• Other study ID #: DP3DK113235
• Secondary ID: 1DP3DK113235-01
• Status: Completed
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2022
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	Nemours Children's Hospital	Orlando	Florida
United States	Alfred I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Problem Areas in Diabetes (PAID) Scale - Adolescent Report	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.	Baseline (upon enrollment); 6 months; 12 months
Other	Problem Areas in Diabetes (PAID) Scale - Caregiver Report	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.	Baseline (upon enrollment); 6 months; 12 months
Other	Type 1 Diabetes and Life (T1DAL) - Youth Self Report	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.	Baseline (upon enrollment); 6 months; 12 months (end of study)
Other	Type 1 Diabetes and Life (T1DAL) Scale - Caregiver Report	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.	Baseline (upon enrollment); 6 months; 12 months (end of study)
Primary	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	Diabetes Self Management Profile-Self Report Form	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.	baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)
Secondary	Diabetes Self Management Profile - Parent Proxy Report	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.	baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)