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| ID | Type | Description | Link |
|---|---|---|---|
| 1DP3DK113235-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Adolescents:
Parents:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Alderfer, PhD | Nemours Children's Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 16803 | United States | ||
| Nemours Children's Clinic |
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).
Once analyses of primary study hypotheses have been completed and published, the de-identified data set will be available for 5 years.
Contact the PI with a data use request and initiate a Data Use Agreement if the request is deemed to be feasible.
Not provided
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.
Adolescents with T1D and their caregiver were recruited and randomized as a dyad. 115 dyads (families) enrolled in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | 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. |
| FG001 | Transdisciplinary Care (In Person or Telehealth) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization to 3 Months |
|
| ||||||||||||||||||||||||
| 3 to 6 Months |
| |||||||||||||||||||||||||
| 6 to 9 Months |
| |||||||||||||||||||||||||
| 9 to 12 Months (End of Study) |
|
Adolescents with T1D and their caregivers were recruited and randomized to condition as a dyad. Diabetes-related medical variables (i.e., HbA1c) are only relevant for the adolescent participants and patient-reported outcomes (e.g., T1D treatment adherence, diabetes-related distress, diabetes-related quality of life) are reported separately by adolescents and caregivers and are reported here separately for these subsamples.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Adolescents with T1D and their caregivers were recruited and randomized to condition as a dyad. Demographic information is being reported separately for participating adolescents and their caregivers. Two caregivers failed to report their age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycosylated Hemoglobin (HbA1c) | HbA1c expressed as percentage of glycosylated hemoglobin | 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. | Posted | Mean | Standard Deviation | 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) |
|
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.
ClinicalTrials.gov definitions are being used. Serious Adverse Events include hospitalizations for any reason and emergency room visits related to diabetes care.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Hospitalization related to diabetes | Endocrine disorders | Systematic Assessment | Two instances of the AE reported for those randomized to TC occurred prior to beginning the intervention (1 patient) or after opting out of TC and returning to Usual Care (1 patient) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase of 1.5% or more in HbA1c from one data point to another during study participation | Endocrine disorders | Systematic Assessment | Seven instances of this AE were reported among 7 TC participants prior to their receipt of the TC intervention. Two additionally instances occurred among 2 participants randomized to TC but opting to return to Usual Care prior to receiving TC |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa A. Alderfer, Ph.D., Center Director & Principal Research Scientist | Nemours Children's Hospital, Delaware | 302-651-6522 | melissa.alderfer@nemours.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2020 | Jul 23, 2020 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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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).
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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.
|
| 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. |
|
| 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) |
| 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 |
| 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) |
| 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) |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Nemours Children's Hospital | Orlando | Florida | 33827 | United States |
| Caregiver Participants |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Caregiver Participants |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Caregiver Participants |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG001 | Transdisciplinary Care (In Person or Telehealth) | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is being provided separately for adolescents and their caregivers. One caregiver did not provide their demographic information. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Demographic information is provided separately for adolescent participants and their caregivers. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers | Count of Participants | Participants |
|
| HbA1c | percentage glycosylated hemoglobin. Higher values indicate poorer glycemic control. | HbA1c was only collected for adolescent participants, not their caregivers | Mean | Standard Deviation | percentage glycosylated hemoglobin |
|
| Diabetes Self Management Profile - Youth Self Report | The Diabetes Self Management Profile - Self report version is completed by adolescents and assesses their adherence to T1D care. Total scores range from 0 to 84 points. Higher scores indicate better adherence/self-management | Two participants did not complete the measure at baseline | Mean | Standard Deviation | score on a scale |
|
| Diabetes Self Management Profile - Parent Proxy Report | The Diabetes Self Management Profile - Parent proxy version is completed by a caregiver and reports on their adolescent's adherence to T1D care. Total scores range from 0 to 84 points. Higher scores indicate better adherence. | This measure was completed by caregivers. One caregiver did not provide complete data on this measure at baseline | Mean | Standard Deviation | score on a scale |
|
| OG001 | Transdisciplinary Care (In Person or Telehealth) | 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. |
|
|
|
| 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. | These are raw data from all adolescent participants providing data. Decrements in the number of participants are due to missing data. | Posted | Mean | Standard Deviation | score on a scale | 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. | These are raw data. Discrepancies in participant numbers are due to missing data. | Posted | Mean | Standard Deviation | score on a scale | baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5) |
|
|
|
|
| Other Pre-specified | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (upon enrollment); 6 months; 12 months |
|
|
|
|
| Other Pre-specified | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (upon enrollment); 6 months; 12 months |
|
|
|
|
| Other Pre-specified | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (upon enrollment); 6 months; 12 months (end of study) |
|
|
|
|
| Other Pre-specified | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (upon enrollment); 6 months; 12 months (end of study) |
|
|
|
|
| 0 |
| 37 |
| 3 |
| 37 |
| 18 |
| 37 |
| EG001 | Transdisciplinary Care (In Person or Telehealth) | 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. | 0 | 67 | 7 | 67 | 26 | 67 |
|
| Emergency Room visit related to diabetes | Endocrine disorders | Systematic Assessment | One instance of this AE occurred for a patient randomized to TC before receiving the intervention. Two additional instances of this AE occurred for a patient randomized to TC who opted to return to Usual Care prior to receiving any TC care visits |
|
| Inpatient Hospitalization unrelated to diabetes | General disorders | Systematic Assessment | Instances included appendicitis and injury |
|
|
| Decrease in QoL of 1.5SD or more | General disorders | Systematic Assessment | Two instances of this AE (drop from baseline to 6 months and drop from baseline to 12 months) were reported by 1 participant randomized to TC but who opted to return to Usual Care before receiving TC |
|
| Gap in clinical care of 6 months or more | Surgical and medical procedures | Systematic Assessment | All instances of this AE reported for participants randomized to TC occurred after the participant opted out of the assigned intervention |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 12 month assessment |
|
|
| 12 month assessment |
|
|
| 6 months |
|
|
| 12 months (end of study) |
|
|
| 6 months |
|
|
| 12 months |
|
|
| 6 months |
|
|
| 12 months |
|
|
| 6 months |
|
|
| 12 months |
|
|