Trial Outcomes & Findings for Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence (NCT NCT03557151)
NCT ID: NCT03557151
Last Updated: 2022-08-05
Results Overview
HbA1c expressed as percentage of glycosylated hemoglobin
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
230 participants
Primary outcome 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)
Results posted on
2022-08-05
Participant Flow
Adolescents with T1D and their caregiver were recruited and randomized as a dyad. 115 dyads (families) enrolled in the study
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Randomization to 3 Months
STARTED
|
74
|
134
|
|
Randomization to 3 Months
Adolescent Participants
|
37
|
67
|
|
Randomization to 3 Months
Caregiver Participants
|
37
|
67
|
|
Randomization to 3 Months
COMPLETED
|
72
|
132
|
|
Randomization to 3 Months
NOT COMPLETED
|
2
|
2
|
|
3 to 6 Months
STARTED
|
72
|
132
|
|
3 to 6 Months
Adolescent Participants
|
36
|
66
|
|
3 to 6 Months
Caregiver Participants
|
36
|
66
|
|
3 to 6 Months
COMPLETED
|
72
|
132
|
|
3 to 6 Months
NOT COMPLETED
|
0
|
0
|
|
6 to 9 Months
STARTED
|
72
|
132
|
|
6 to 9 Months
Adolescent Participants
|
36
|
66
|
|
6 to 9 Months
Caregiver Participants
|
36
|
66
|
|
6 to 9 Months
COMPLETED
|
70
|
132
|
|
6 to 9 Months
NOT COMPLETED
|
2
|
0
|
|
9 to 12 Months (End of Study)
STARTED
|
70
|
132
|
|
9 to 12 Months (End of Study)
Adolescent Participants
|
35
|
66
|
|
9 to 12 Months (End of Study)
Caregiver Participants
|
35
|
66
|
|
9 to 12 Months (End of Study)
COMPLETED
|
70
|
130
|
|
9 to 12 Months (End of Study)
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Randomization to 3 Months
Lost to Follow-up
|
2
|
2
|
|
6 to 9 Months
moved out of state/discontinued care at Nemours
|
2
|
0
|
|
9 to 12 Months (End of Study)
moved out of state/discontinued care at Nemours
|
0
|
2
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Usual Care
n=74 Participants
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 (In Person or Telehealth)
n=134 Participants
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
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Adolescents
|
13.88 years
STANDARD_DEVIATION 1.77 • n=37 Participants • 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.
|
14.07 years
STANDARD_DEVIATION 1.74 • n=67 Participants • 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.
|
14.01 years
STANDARD_DEVIATION 1.75 • n=104 Participants • 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.
|
|
Age, Continuous
Caregivers of adolescents
|
42.61 years
STANDARD_DEVIATION 6.89 • n=36 Participants • 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.
|
42.98 years
STANDARD_DEVIATION 7.06 • n=66 Participants • 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.
|
42.85 years
STANDARD_DEVIATION 6.97 • n=102 Participants • 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.
|
|
Sex: Female, Male
Adolescents · Female
|
19 Participants
n=37 Participants • 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.
|
36 Participants
n=67 Participants • 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.
|
55 Participants
n=104 Participants • 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.
|
|
Sex: Female, Male
Adolescents · Male
|
18 Participants
n=37 Participants • 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.
|
31 Participants
n=67 Participants • 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.
|
49 Participants
n=104 Participants • 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.
|
|
Sex: Female, Male
Caregivers of adolescents · Female
|
33 Participants
n=37 Participants • 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.
|
58 Participants
n=66 Participants • 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.
|
91 Participants
n=103 Participants • 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.
|
|
Sex: Female, Male
Caregivers of adolescents · Male
|
4 Participants
n=37 Participants • 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.
|
8 Participants
n=66 Participants • 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.
|
12 Participants
n=103 Participants • 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.
|
|
Ethnicity (NIH/OMB)
Adolescents · Hispanic or Latino
|
8 Participants
n=37 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
11 Participants
n=67 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
19 Participants
n=104 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
|
Ethnicity (NIH/OMB)
Adolescents · Not Hispanic or Latino
|
29 Participants
n=37 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
54 Participants
n=67 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
83 Participants
n=104 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
|
Ethnicity (NIH/OMB)
Adolescents · Unknown or Not Reported
|
0 Participants
n=37 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
2 Participants
n=67 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
2 Participants
n=104 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
6 Participants
n=37 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
11 Participants
n=67 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
17 Participants
n=104 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
31 Participants
n=37 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
55 Participants
n=67 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
86 Participants
n=104 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=37 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
1 Participants
n=67 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
1 Participants
n=104 Participants • Demographic information is provided separately for adolescent participants and their caregivers.
|
|
Race (NIH/OMB)
Adolescents · American Indian or Alaska Native
|
0 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
0 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
0 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Adolescents · Asian
|
1 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
0 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
1 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Adolescents · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
0 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
0 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Adolescents · Black or African American
|
5 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
13 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
18 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Adolescents · White
|
23 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
43 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
66 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Adolescents · More than one race
|
5 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
7 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
12 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Adolescents · Unknown or Not Reported
|
3 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
4 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
7 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Caregivers of adolescents · American Indian or Alaska Native
|
0 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
0 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
0 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Caregivers of adolescents · Asian
|
0 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
0 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
0 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Caregivers of adolescents · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
0 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
0 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Caregivers of adolescents · Black or African American
|
5 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
13 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
18 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Caregivers of adolescents · White
|
26 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
43 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
69 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Caregivers of adolescents · More than one race
|
1 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
6 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
7 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
Race (NIH/OMB)
Caregivers of adolescents · Unknown or Not Reported
|
5 Participants
n=37 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
5 Participants
n=67 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
10 Participants
n=104 Participants • Adolescents with T1D and their caregivers were recruited and randomized as a dyad. Demographic information is presented separately for adolescent participants and their caregivers
|
|
HbA1c
|
8.52 percentage glycosylated hemoglobin
STANDARD_DEVIATION 1.19 • n=37 Participants • HbA1c was only collected for adolescent participants, not their caregivers
|
8.87 percentage glycosylated hemoglobin
STANDARD_DEVIATION 1.26 • n=67 Participants • HbA1c was only collected for adolescent participants, not their caregivers
|
8.74 percentage glycosylated hemoglobin
STANDARD_DEVIATION 1.24 • n=104 Participants • HbA1c was only collected for adolescent participants, not their caregivers
|
|
Diabetes Self Management Profile - Youth Self Report
|
53.87 score on a scale
STANDARD_DEVIATION 12.33 • n=37 Participants • Two participants did not complete the measure at baseline
|
52.37 score on a scale
STANDARD_DEVIATION 11.39 • n=65 Participants • Two participants did not complete the measure at baseline
|
52.92 score on a scale
STANDARD_DEVIATION 11.70 • n=102 Participants • Two participants did not complete the measure at baseline
|
|
Diabetes Self Management Profile - Parent Proxy Report
|
55.20 score on a scale
STANDARD_DEVIATION 12.1 • n=37 Participants • This measure was completed by caregivers. One caregiver did not provide complete data on this measure at baseline
|
53.68 score on a scale
STANDARD_DEVIATION 11.97 • n=66 Participants • This measure was completed by caregivers. One caregiver did not provide complete data on this measure at baseline
|
54.23 score on a scale
STANDARD_DEVIATION 11.98 • n=103 Participants • This measure was completed by caregivers. One caregiver did not provide complete data on this measure at baseline
|
PRIMARY outcome
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)Population: 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.
HbA1c expressed as percentage of glycosylated hemoglobin
Outcome measures
| Measure |
Usual Care
n=37 Participants
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 (In Person or Telehealth)
n=67 Participants
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.
|
|---|---|---|
|
Glycosylated Hemoglobin (HbA1c)
3 months
|
8.59 percentage of glycosylated hemoglobin
Standard Deviation 1.56
|
9.02 percentage of glycosylated hemoglobin
Standard Deviation 1.50
|
|
Glycosylated Hemoglobin (HbA1c)
6 months
|
8.71 percentage of glycosylated hemoglobin
Standard Deviation 1.41
|
9.03 percentage of glycosylated hemoglobin
Standard Deviation 1.58
|
|
Glycosylated Hemoglobin (HbA1c)
9 months
|
8.59 percentage of glycosylated hemoglobin
Standard Deviation 1.66
|
8.98 percentage of glycosylated hemoglobin
Standard Deviation 1.27
|
|
Glycosylated Hemoglobin (HbA1c)
12 months
|
8.45 percentage of glycosylated hemoglobin
Standard Deviation 1.21
|
8.97 percentage of glycosylated hemoglobin
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)Population: These are raw data from all adolescent participants providing data. Decrements in the number of participants are due to missing data.
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.
Outcome measures
| Measure |
Usual Care
n=37 Participants
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 (In Person or Telehealth)
n=67 Participants
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.
|
|---|---|---|
|
Diabetes Self Management Profile-Self Report Form
6 month assessment
|
53.45 score on a scale
Standard Deviation 11.55
|
55.99 score on a scale
Standard Deviation 11.86
|
|
Diabetes Self Management Profile-Self Report Form
12 month assessment
|
53.97 score on a scale
Standard Deviation 10.61
|
55.09 score on a scale
Standard Deviation 12.09
|
SECONDARY outcome
Timeframe: baseline (enrollment; visit 1); 6 months (visit 3); 12 months (end of study, visit 5)Population: These are raw data. Discrepancies in participant numbers are due to missing data.
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.
Outcome measures
| Measure |
Usual Care
n=37 Participants
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 (In Person or Telehealth)
n=67 Participants
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.
|
|---|---|---|
|
Diabetes Self Management Profile - Parent Proxy Report
6 month assessment
|
53.73 score on a scale
Standard Deviation 11.39
|
54.44 score on a scale
Standard Deviation 12.27
|
|
Diabetes Self Management Profile - Parent Proxy Report
12 month assessment
|
52.67 score on a scale
Standard Deviation 14.40
|
55.64 score on a scale
Standard Deviation 13.72
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (upon enrollment); 6 months; 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Usual Care
n=37 Participants
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 (In Person or Telehealth)
n=66 Participants
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.
|
|---|---|---|
|
Problem Areas in Diabetes (PAID) Scale - Adolescent Report
6 months
|
39.57 score on a scale
Standard Deviation 15.01
|
30.12 score on a scale
Standard Deviation 13.97
|
|
Problem Areas in Diabetes (PAID) Scale - Adolescent Report
12 months (end of study)
|
37.12 score on a scale
Standard Deviation 17.16
|
30.55 score on a scale
Standard Deviation 16.78
|
|
Problem Areas in Diabetes (PAID) Scale - Adolescent Report
Baseline
|
38.73 score on a scale
Standard Deviation 16.88
|
35.62 score on a scale
Standard Deviation 16.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (upon enrollment); 6 months; 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Usual Care
n=37 Participants
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 (In Person or Telehealth)
n=66 Participants
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.
|
|---|---|---|
|
Problem Areas in Diabetes (PAID) Scale - Caregiver Report
Baseline
|
52.85 score on a scale
Standard Deviation 17.40
|
44.92 score on a scale
Standard Deviation 19.73
|
|
Problem Areas in Diabetes (PAID) Scale - Caregiver Report
6 months
|
54.42 score on a scale
Standard Deviation 17.10
|
43.24 score on a scale
Standard Deviation 19.44
|
|
Problem Areas in Diabetes (PAID) Scale - Caregiver Report
12 months
|
53.46 score on a scale
Standard Deviation 15.91
|
42.15 score on a scale
Standard Deviation 18.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (upon enrollment); 6 months; 12 months (end of study)Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=36 Participants
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 (In Person or Telehealth)
n=66 Participants
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.
|
|---|---|---|
|
Type 1 Diabetes and Life (T1DAL) - Youth Self Report
12 months
|
57.76 score on a scale
Standard Deviation 17.04
|
67.66 score on a scale
Standard Deviation 19.71
|
|
Type 1 Diabetes and Life (T1DAL) - Youth Self Report
Baseline
|
61.84 score on a scale
Standard Deviation 16.62
|
61.46 score on a scale
Standard Deviation 18.21
|
|
Type 1 Diabetes and Life (T1DAL) - Youth Self Report
6 months
|
57.85 score on a scale
Standard Deviation 15.81
|
67.76 score on a scale
Standard Deviation 18.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (upon enrollment); 6 months; 12 months (end of study)Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=37 Participants
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 (In Person or Telehealth)
n=66 Participants
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.
|
|---|---|---|
|
Type 1 Diabetes and Life (T1DAL) Scale - Caregiver Report
Baseline
|
55.97 score on a scale
Standard Deviation 11.50
|
65.64 score on a scale
Standard Deviation 14.74
|
|
Type 1 Diabetes and Life (T1DAL) Scale - Caregiver Report
6 months
|
56.62 score on a scale
Standard Deviation 10.10
|
66.73 score on a scale
Standard Deviation 14.54
|
|
Type 1 Diabetes and Life (T1DAL) Scale - Caregiver Report
12 months
|
55.36 score on a scale
Standard Deviation 11.20
|
66.32 score on a scale
Standard Deviation 15.80
|
Adverse Events
Usual Care
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Transdisciplinary Care (In Person or Telehealth)
Serious events: 7 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=37 participants at risk
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 (In Person or Telehealth)
n=67 participants at risk
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.
|
|---|---|---|
|
Endocrine disorders
Inpatient Hospitalization related to diabetes
|
2.7%
1/37 • Number of events 1 • 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.
|
4.5%
3/67 • Number of events 3 • 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.
|
|
Endocrine disorders
Emergency Room visit related to diabetes
|
2.7%
1/37 • Number of events 1 • 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.
|
9.0%
6/67 • Number of events 8 • 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.
|
|
General disorders
Inpatient Hospitalization unrelated to diabetes
|
2.7%
1/37 • Number of events 1 • 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.
|
1.5%
1/67 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Usual Care
n=37 participants at risk
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 (In Person or Telehealth)
n=67 participants at risk
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.
|
|---|---|---|
|
Endocrine disorders
Increase of 1.5% or more in HbA1c from one data point to another during study participation
|
18.9%
7/37 • Number of events 14 • 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.
|
28.4%
19/67 • Number of events 28 • 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.
|
|
General disorders
Decrease in QoL of 1.5SD or more
|
21.6%
8/37 • Number of events 8 • 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.
|
10.4%
7/67 • Number of events 8 • 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.
|
|
Surgical and medical procedures
Gap in clinical care of 6 months or more
|
21.6%
8/37 • Number of events 9 • 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.
|
7.5%
5/67 • Number of events 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.
|
Additional Information
Melissa A. Alderfer, Ph.D., Center Director & Principal Research Scientist
Nemours Children's Hospital, Delaware
Phone: 302-651-6522
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place