Type 1 Diabetes
Conditions
Keywords
Adolescence, Adherence
Brief summary
The purpose of this study is to determine whether a newly developed intervention is feasible and acceptable to adolescents with type 1 diabetes and their families and diabetes care providers, and to evaluate trends in whether the intervention impacts important diabetes outcomes. The intervention involves diabetes care providers discussing and reinforcing individuals' and families' diabetes management strengths during routine, outpatient diabetes care appointments.
Detailed description
The purpose of this study is to pilot test a newly developed strengths-based clinical intervention delivered by diabetes care providers in the context of routine ambulatory diabetes care, designed to promote resilience and support diabetes management among adolescents with type 1 diabetes and their families. The emphasis of the intervention is shifting the tone of clinical encounters for diabetes care to emphasize and reinforce youths' and families' current diabetes strengths and positive diabetes management behaviors. Youth with type 1 diabetes are seen routinely in clinic every 3-4 months, and this intervention will occur at two consecutive clinic visits. The intervention consists of (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments. Outcome assessments are conducted at baseline (prior to the start of the intervention) and immediately following the conclusion of the intervention (approximately 6-8 months later). The primary outcome is feasibility and acceptability, measured by qualitative feedback from participants and providers, as well as quantification of recruitment and enrollment, provider adherence to intervention protocol, and time to completion. Secondary (exploratory) outcomes include diabetes regimen adherence, glycemic control, family conflict, diabetes burden, diabetes strengths, and satisfaction with the diabetes care provider relationship. Strengths and adherence assessments are also completed prior to the second clinic visit to generate the diabetes strengths profile.
Interventions
BEHAVIORALDiabetes Strengths Study
The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. At least one parent of each adolescent, self-identified as the primary caregiver most involved in diabetes care, will also be enrolled with each adolescent participant. When present, secondary caregivers involved in diabetes management will be invited (not required) to participate. 2. Youth type 1 diabetes diagnosis for at least 12 months, to allow ample opportunity for adjustment to diabetes management 3. Youth and parent fluency in written and spoken English because assessment measures are not available in other languages.
Exclusion criteria
(1) Presence of a serious mental illness or developmental disability in youth or parent that would impede participation would exclude eligibility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Study Design | Immediately following Enrollment (Baseline) | Measured by percent of recruited families that enrolled in study |
| Acceptability: Number of Participants That Felt the Intervention Was Well-Received | 6-8 months after enrollment (follow-up timepoint) | The number of participants that felt the intervention was well-received was collected for Adolescents, Parents, and Providers. To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team. We coded these data qualitatively and classified them as Positive, Negative, or Neutral. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Self-Management Profile - Adolescent-report | 6-8 months after enrollment (follow-up timepoint) | Adolescents will complete the youth-report version of the Diabetes Self-Management Profile Self-Report, a self-reported measure of adherence to diabetes regimen, at baseline and follow-up to assess their perceptions of adherence. The version appropriate to the adolescents' current diabetes regimen (conventional insulin regimen, 24 items; or intensive insulin regimen, 24 items) will be administered. The scale ranges from 0-86, with a higher score representing a better outcome. |
| Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency) | 6-8 months after enrollment (follow-up timepoint) | Objective measurement of adherence will occur through blood glucose monitoring frequency (a well-accepted surrogate of overall adherence), obtained via blood glucose meter downloads. The average daily frequency will be calculated over the 14 days prior to the assessment at the Baseline and second study visits. |
| Glycemic Control | 6-8 months after enrollment (follow-up timepoint) | Diabetes is typically diagnosed with an HbA1c of 6.5% or higher. At the time of this study, the American Diabetes Association generally recommended an HbA1c target of \<7.5% for individuals younger than 18 years (the specific target varies depending on the individual). The DCA 2000 HbA1c Analyzer (Siemens-Bayer) was used for point of care HbA1c analysis, it has an analytical measurement range for HbA1c of 2.5% to 14.0%. HbA1c values are collected via fingerstick and blood assay at routine diabetes care visits and values will be extracted from the medical record at each clinic visit during the study period. |
| Problem Areas in Diabetes - Teen | 6-8 months after enrollment (follow-up timepoint) | Burden will be assessed via the Problem Areas in Diabetes - Teen. The scale has 26 items and demonstrates good psychometric properties. The scale ranges from 26-156, with higher scores representing worse outcomes. |
| Diabetes Burden - Problem Areas in Diabetes - Parent-report | 6-8 months after enrollment (follow-up timepoint) | Burden will be assessed via the Problem Areas in Diabetes measures for parents. The scale has 26 items and demonstrates good psychometric properties. The scale ranges from 26-156, with a higher score representing a worse outcome. |
| Diabetes Strengths | 3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint) | Adolescent will self-report on the frequency of 12 resilience-promoting behaviors via the Diabetes Strengths and Resilience, a self-report assessment of positive behaviors related to diabetes resilience for youth with type 1 diabetes, such as perceived competence to manage the demanding diabetes regimen, to adapt to the unpredictability of diabetes, and to seek help and support with diabetes challenges. The scale ranges from 0-48, with a higher score representing a better outcome. |
| Diabetes-related Family Conflict (Adolescent Report) | 6-8 months after enrollment (follow-up timepoint) | Adolescents will also complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity. The scale ranges from 19-57, with higher scores representing a worse outcome. |
| Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report | 6-8 months after enrollment (follow-up timepoint) | To assess healthcare satisfaction, parents will complete three subscales of the PedsQL Inventory Healthcare Satisfaction Generic Module, assessing their satisfaction with communication, inclusion of family, and how well the patient's emotional needs are addressed during the clinical encounter (13 items). The scale ranges from 0-100, with a higher score representing a better outcome. |
| Adolescent-provider Relationship - Adolescent-report | 6-8 months after enrollment (follow-up timepoint) | Adolescents will rate their overall satisfaction with the patient-provider relationship on a 1-10 scale single item developed for this study, as there is no validated youth-report measure of satisfaction with care. The scale ranges from 1-10, with higher scores representing a better outcome. |
| Provider-family Relationship, Provider-report | 6-8 months after enrollment (follow-up timepoint) | Providers will rate their overall satisfaction with the provider-family relationship on a scale developed for this study. The Provider-Family Relationship scale measures the provider's perspective on the quality of their relationship with the teen and family. 4 healthcare providers completed this scale for 48 families. The scale range of the minimum to maximum possible score is 1-10. A higher score represents a better outcome. |
| Diabetes-related Family Conflict (Parent-report) | 6-8 months after enrollment (follow-up timepoint) | Parents will complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity. The scale ranges from 19-57, with higher scores representing a worse outcome. |
| Diabetes Self-Management Profile - Parent-report | 3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint) | Parents will rate adolescents' adherence to the diabetes regimen using the 24-item Diabetes Self-Management Profile Self-Report. The version appropriate to their child's current diabetes regimen (conventional insulin regimen, 24 items; flexible insulin regimen, 24 items) was administered. The scale ranges from 0-86, with a higher score representing a better outcome. |
Countries
United States
Participant flow
Recruitment details
Recruited from diabetes clinics at Texas Children's Hospital
Pre-assignment details
Of 172 individuals (84 parents, 84 adolescents, 4 providers) consented, n=40 (20 parent-adolescent dyads) did not receive the intervention: 18 (9 dyads) transferred care to a provider not trained in intervention, 20 (10 dyads) because their provider retired & insufficient time to reschedule in study period, 2 (1 dyad) due to time constraints
Participants by arm
| Arm | Count |
|---|---|
| Adolescent There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Adolescent group completed different sets of questionnaires than the Parent and Provider groups.
Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments. | 64 |
| Parent There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Parent group completed different sets of questionnaires than the Adolescent and Provider groups.
Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments | 64 |
| Provider There is no control/comparator group for this pilot study - adolescents and their parent receive the intervention that is delivered by their provider. The Provider group completed different sets of questionnaires than the Adolescent and Parent groups. Diabetes care providers were trained to deliver the intervention and were asked to complete sets of questionnaires at various timepoints.
Diabetes Strengths Study: The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments | 4 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Provider Retired/No Time to Reschedule | 10 | 10 | 0 |
| Overall Study | Time Constraints | 1 | 1 | 0 |
| Overall Study | Transferred Care | 9 | 9 | 0 |
Baseline characteristics
| Characteristic | Total | Adolescent | Parent | Provider |
|---|---|---|---|---|
| Adolescent-provider relationship, adolescent-report | 7.9 units on a scale STANDARD_DEVIATION 1.6 | 7.9 units on a scale STANDARD_DEVIATION 1.6 | — | — |
| Age, Continuous | 15.0 years STANDARD_DEVIATION 1.8 | 15.0 years STANDARD_DEVIATION 1.8 | — | — |
| Diabetes Family Conflict Scale - Revised, Adolescent-report | 25.5 units on a scale STANDARD_DEVIATION 5.7 | 25.5 units on a scale STANDARD_DEVIATION 5.7 | — | — |
| Diabetes Family Conflict Scale - Revised, Parent-report | 24.7 units on a scale STANDARD_DEVIATION 4.8 | — | 24.7 units on a scale STANDARD_DEVIATION 4.8 | — |
| Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency) | 3.6 checks per day STANDARD_DEVIATION 1.4 | 3.6 checks per day STANDARD_DEVIATION 1.4 | — | — |
| Diabetes Self-Management Profile - Adolescent Self-Report | 52.5 units on a scale STANDARD_DEVIATION 10.3 | 52.5 units on a scale STANDARD_DEVIATION 10.3 | — | — |
| Diabetes Self-Management Profile - Parent-report | 54.4 units on a scale STANDARD_DEVIATION 9.2 | — | 54.4 units on a scale STANDARD_DEVIATION 9.2 | — |
| Diabetes Strengths and Resilience Measure - Adolescent | 37.0 units on a scale STANDARD_DEVIATION 6.6 | 37.0 units on a scale STANDARD_DEVIATION 6.6 | — | — |
| Glycemic Control (HbA1c) | 8.6 percentage STANDARD_DEVIATION 1.6 | 8.56 percentage STANDARD_DEVIATION 1.6 | — | — |
| PedsQL-Healthcare Satisfaction, parent-report | 96.4 units on a scale STANDARD_DEVIATION 6.5 | — | 96.4 units on a scale STANDARD_DEVIATION 6.5 | — |
| Problem Areas in Diabetes - Adolescent Self-report | 68.6 units on a scale STANDARD_DEVIATION 28 | 68.6 units on a scale STANDARD_DEVIATION 28 | — | — |
| Problem Areas in Diabetes - Parent-report | 71.3 units on a scale STANDARD_DEVIATION 25.2 | — | 71.3 units on a scale STANDARD_DEVIATION 25.2 | — |
| Provider-family relationship, provider-report | 8.7 units on a scale STANDARD_DEVIATION 1 | — | — | 8.7 units on a scale STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | — | — |
| Race (NIH/OMB) Black or African American | 8 Participants | 8 Participants | — | — |
| Race (NIH/OMB) More than one race | 8 Participants | 8 Participants | — | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — | — |
| Race (NIH/OMB) White | 44 Participants | 44 Participants | — | — |
| Region of Enrollment United States | 132 participants | 64 participants | 64 participants | 4 participants |
| Sex: Female, Male Female | 89 Participants | 36 Participants | 53 Participants | — |
| Sex: Female, Male Male | 39 Participants | 28 Participants | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 84 | 0 / 4 |
| other Total, other adverse events | 0 / 84 | 0 / 84 | 0 / 4 |
| serious Total, serious adverse events | 0 / 84 | 0 / 84 | 0 / 4 |
Outcome results
Primary
Acceptability: Number of Participants That Felt the Intervention Was Well-Received
The number of participants that felt the intervention was well-received was collected for Adolescents, Parents, and Providers. To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team. We coded these data qualitatively and classified them as Positive, Negative, or Neutral.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: n = number with complete data at this follow-up timepoint to calculate a score.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adolescent | Acceptability: Number of Participants That Felt the Intervention Was Well-Received | Negative | 0 Participants |
| Adolescent | Acceptability: Number of Participants That Felt the Intervention Was Well-Received | Positive | 46 Participants |
| Adolescent | Acceptability: Number of Participants That Felt the Intervention Was Well-Received | Neutral | 7 Participants |
| Parent | Acceptability: Number of Participants That Felt the Intervention Was Well-Received | Negative | 0 Participants |
| Parent | Acceptability: Number of Participants That Felt the Intervention Was Well-Received | Positive | 44 Participants |
| Parent | Acceptability: Number of Participants That Felt the Intervention Was Well-Received | Neutral | 8 Participants |
| Provider | Acceptability: Number of Participants That Felt the Intervention Was Well-Received | Positive | 4 Participants |
| Provider | Acceptability: Number of Participants That Felt the Intervention Was Well-Received | Neutral | 0 Participants |
| Provider | Acceptability: Number of Participants That Felt the Intervention Was Well-Received | Negative | 0 Participants |
Primary
Feasibility of Study Design
Measured by percent of recruited families that enrolled in study
Time frame: Immediately following Enrollment (Baseline)
Population: Over 12 months (10/2014-9/2015), staff screened 212 adolescents for eligibility via electronic medical record, of whom 8 could not be contacted, 11 opted out of learning about research before the study could be introduced, \& 88 were ineligible. Of the remaining 105 adolescents, 21 declined to participate, resulting in a consent rate of 80% (n=84).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent | Feasibility of Study Design | 84 Participants |
| Parent | Feasibility of Study Design | 84 Participants |
Primary
Feasibility of Study Design
Measured by percent of enrolled participants who receive full dose
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: 84 ppts enrolled. 64 (76% of consented, 61% of eligible invited to participate) completed baseline surveys \& were eligible to participate in the intervention. 63 (75% of consented, 98% of ppts with baseline data) received at least one intervention session. 53 (63% of consented, 83% of ppts with baseline data) completed 2 intervention sessions.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent | Feasibility of Study Design | 53 Participants |
| Parent | Feasibility of Study Design | 53 Participants |
Primary
Feasibility of Study Design
Measured by time to complete intervention in months since enrollment in study.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: Includes participants who completed post-intervention data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent | Feasibility of Study Design | 8.3 months since enrollment | Standard Deviation 3.6 |
| Parent | Feasibility of Study Design | 8.3 months since enrollment | Standard Deviation 3.6 |
Primary
Feasibility of Study Design
Measured by percent of participants who provided complete data from all questionnaires.
Time frame: 6-8 months after intervention begins (immediately following second study visit)
Population: Out of 84 enrolled and 64 who provided baseline data, 60 (71% of enrolled, 94% of ppts with baseline data) provided post-intervention questionnaire battery (some individual measures may not have been complete to calculate a score)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adolescent | Feasibility of Study Design | 60 Participants |
| Parent | Feasibility of Study Design | 60 Participants |
| Provider | Feasibility of Study Design | 4 Participants |
Secondary
Adolescent-provider Relationship - Adolescent-report
Adolescents will rate their overall satisfaction with the patient-provider relationship on a 1-10 scale single item developed for this study, as there is no validated youth-report measure of satisfaction with care. The scale ranges from 1-10, with higher scores representing a better outcome.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: n = number with data at this follow-up timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent | Adolescent-provider Relationship - Adolescent-report | 8.5 units on a scale | Standard Deviation 1.8 |
Secondary
Diabetes Burden - Problem Areas in Diabetes - Parent-report
Burden will be assessed via the Problem Areas in Diabetes measures for parents. The scale has 26 items and demonstrates good psychometric properties. The scale ranges from 26-156, with a higher score representing a worse outcome.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: n = number with complete data at this timepoint to calculate a score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent | Diabetes Burden - Problem Areas in Diabetes - Parent-report | 64.6 units on a scale | Standard Deviation 20.3 |
Secondary
Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency)
Objective measurement of adherence will occur through blood glucose monitoring frequency (a well-accepted surrogate of overall adherence), obtained via blood glucose meter downloads. The average daily frequency will be calculated over the 14 days prior to the assessment at the Baseline and second study visits.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: n = number with complete meter data at this follow-up timepoint to calculate a score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent | Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency) | 3.64 checks per day | Standard Deviation 1.36 |
Secondary
Diabetes-related Family Conflict (Adolescent Report)
Adolescents will also complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity. The scale ranges from 19-57, with higher scores representing a worse outcome.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: n = number with complete data at this follow-up timepoint to calculate a score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent | Diabetes-related Family Conflict (Adolescent Report) | 24.3 units on a scale | Standard Deviation 4.8 |
Secondary
Diabetes-related Family Conflict (Parent-report)
Parents will complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity. The scale ranges from 19-57, with higher scores representing a worse outcome.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: n = number with complete data at this follow-up timepoint to calculate a score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent | Diabetes-related Family Conflict (Parent-report) | 24.9 units on a scale | Standard Deviation 4.6 |
Secondary
Diabetes Self-Management Profile - Adolescent-report
Adolescents will complete the youth-report version of the Diabetes Self-Management Profile Self-Report, a self-reported measure of adherence to diabetes regimen, at baseline and follow-up to assess their perceptions of adherence. The version appropriate to the adolescents' current diabetes regimen (conventional insulin regimen, 24 items; or intensive insulin regimen, 24 items) will be administered. The scale ranges from 0-86, with a higher score representing a better outcome.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: n = number with complete data at this follow-up timepoint to calculate a score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent | Diabetes Self-Management Profile - Adolescent-report | 56.9 units on a scale | Standard Deviation 10.1 |
Secondary
Diabetes Self-Management Profile - Parent-report
Parents will rate adolescents' adherence to the diabetes regimen using the 24-item Diabetes Self-Management Profile Self-Report. The version appropriate to their child's current diabetes regimen (conventional insulin regimen, 24 items; flexible insulin regimen, 24 items) was administered. The scale ranges from 0-86, with a higher score representing a better outcome.
Time frame: 3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
Population: n = number with complete data at baseline timepoint to calculate a score
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adolescent | Diabetes Self-Management Profile - Parent-report | 3-4 months after enrollment (mid-intervention) | 55.2 units on a scale | Standard Deviation 9.5 |
| Adolescent | Diabetes Self-Management Profile - Parent-report | 6-8 months after enrollment (follow-up timepoint) | 56.9 units on a scale | Standard Deviation 10 |
Secondary
Diabetes Strengths
Adolescent will self-report on the frequency of 12 resilience-promoting behaviors via the Diabetes Strengths and Resilience, a self-report assessment of positive behaviors related to diabetes resilience for youth with type 1 diabetes, such as perceived competence to manage the demanding diabetes regimen, to adapt to the unpredictability of diabetes, and to seek help and support with diabetes challenges. The scale ranges from 0-48, with a higher score representing a better outcome.
Time frame: 3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
Population: n = number with complete data at baseline to calculate a score
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adolescent | Diabetes Strengths | 3-4 months after enrollment (mid-intervention) | 38.1 units on a scale | Standard Deviation 5.6 |
| Adolescent | Diabetes Strengths | 6-8 months after enrollment (follow-up timepoint) | 39.7 units on a scale | Standard Deviation 5.8 |
Secondary
Glycemic Control
Diabetes is typically diagnosed with an HbA1c of 6.5% or higher. At the time of this study, the American Diabetes Association generally recommended an HbA1c target of \<7.5% for individuals younger than 18 years (the specific target varies depending on the individual). The DCA 2000 HbA1c Analyzer (Siemens-Bayer) was used for point of care HbA1c analysis, it has an analytical measurement range for HbA1c of 2.5% to 14.0%. HbA1c values are collected via fingerstick and blood assay at routine diabetes care visits and values will be extracted from the medical record at each clinic visit during the study period.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: n = number with HbA1c value available at this follow-up timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent | Glycemic Control | 8.54 percentage | Standard Deviation 1.59 |
Secondary
Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report
To assess healthcare satisfaction, parents will complete three subscales of the PedsQL Inventory Healthcare Satisfaction Generic Module, assessing their satisfaction with communication, inclusion of family, and how well the patient's emotional needs are addressed during the clinical encounter (13 items). The scale ranges from 0-100, with a higher score representing a better outcome.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: n = number with complete data at this follow-up timepoint to calculate a score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent | Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report | 96.1 units on a scale | Standard Deviation 10.3 |
Secondary
Problem Areas in Diabetes - Teen
Burden will be assessed via the Problem Areas in Diabetes - Teen. The scale has 26 items and demonstrates good psychometric properties. The scale ranges from 26-156, with higher scores representing worse outcomes.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: n = number with complete data at this follow-up timepoint to calculate a score
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent | Problem Areas in Diabetes - Teen | 61.6 units on a scale | Standard Deviation 23.6 |
Secondary
Provider-family Relationship, Provider-report
Providers will rate their overall satisfaction with the provider-family relationship on a scale developed for this study. The Provider-Family Relationship scale measures the provider's perspective on the quality of their relationship with the teen and family. 4 healthcare providers completed this scale for 48 families. The scale range of the minimum to maximum possible score is 1-10. A higher score represents a better outcome.
Time frame: 6-8 months after enrollment (follow-up timepoint)
Population: n represents number with complete data to calculate a score. 4 healthcare providers completed this scale for 48 families (adolescent-parent dyads).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adolescent | Provider-family Relationship, Provider-report | 9.1 units on a scale | Standard Deviation 1 |