An interventional study of Diabetes Strengths Study in Type 1 Diabetes, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-02-24.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Other
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.
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 172 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(1) Presence of a serious mental illness or developmental disability in youth or parent that would impede participation would exclude eligibility.
There is no control/comparator group for this pilot study - all participants receive the intervention
Behavioral: 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.
Feasibility of Study Design
Measured by percent of recruited families that enrolled in study
Time frame: Immediately following Enrollment (Baseline)
Feasibility of Study Design
Measured by percent of enrolled participants who receive full dose
Time frame: 6-8 months after enrollment (follow-up timepoint)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Recruited from diabetes clinics at Texas Children's Hospital
| Milestone | Adolescent | Parent | Provider |
|---|---|---|---|
| Started | 84 | 84 | 4 |
| Completed | 64 | 64 | 4 |
| Not completed | 20 | 20 | 0 |
| Withdrew: Transferred care | 9 | 9 | 0 |
| Withdrew: Provider retired/no time to reschedule | 10 | 10 | 0 |
| Withdrew: Time constraints | 1 | 1 | 0 |
Measured by percent of recruited families that enrolled in study
| Participants | Adolescent | Parent |
|---|---|---|
| Feasibility of Study Design | 84 | 84 |
Measured by percent of enrolled participants who receive full dose
| Participants | Adolescent | Parent |
|---|---|---|
| Feasibility of Study Design | 53 | 53 |
Measured by time to complete intervention in months since enrollment in study.
| months since enrollment | Adolescent | Parent |
|---|---|---|
| Feasibility of Study Design | 8.3 ± 3.6 | 8.3 ± 3.6 |
Measured by percent of participants who provided complete data from all questionnaires.
| Participants | Adolescent | Parent | Provider |
|---|---|---|---|
| Feasibility of Study Design | 60 | 60 | 4 |
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.
| Participants | Adolescent | Parent | Provider |
|---|---|---|---|
| Positive | 46 | 44 | 4 |
| Negative | 0 | 0 | 0 |
| Neutral | 7 | 8 | 0 |
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.
| units on a scale | Adolescent |
|---|---|
| 3-4 months after enrollment (mid-intervention) | 38.1 ± 5.6 |
| 6-8 months after enrollment (follow-up timepoint) | 39.7 ± 5.8 |
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.
| units on a scale | Parent |
|---|---|
| 3-4 months after enrollment (mid-intervention) | 55.2 ± 9.5 |
| 6-8 months after enrollment (follow-up timepoint) | 56.9 ± 10.0 |
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.
| units on a scale | Adolescent |
|---|---|
| Diabetes Self-Management Profile - Adolescent-report | 56.9 ± 10.1 |
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.
| checks per day | Adolescent |
|---|---|
| Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency) | 3.64 ± 1.36 |
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.
| percentage | Adolescent |
|---|---|
| Glycemic Control | 8.54 ± 1.59 |
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.
| units on a scale | Adolescent |
|---|---|
| Problem Areas in Diabetes - Teen | 61.6 ± 23.6 |
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.
| units on a scale | Parent |
|---|---|
| Diabetes Burden - Problem Areas in Diabetes - Parent-report | 64.6 ± 20.3 |
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.
| units on a scale | Parent |
|---|---|
| Diabetes-related Family Conflict (Parent-report) | 24.9 ± 4.6 |
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.
| units on a scale | Adolescent |
|---|---|
| Diabetes-related Family Conflict (Adolescent Report) | 24.3 ± 4.8 |
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.
| units on a scale | Parent |
|---|---|
| Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report | 96.1 ± 10.3 |
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.
| units on a scale | Adolescent |
|---|---|
| Adolescent-provider Relationship - Adolescent-report | 8.5 ± 1.8 |
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.
| units on a scale | Provider |
|---|---|
| Provider-family Relationship, Provider-report | 9.1 ± 1.0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adolescent | 0/84 (0%) | 0/84 (0%) | 0/84 (0%) |
| Parent | 0/84 (0%) | 0/84 (0%) | 0/84 (0%) |
| Provider | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
Of 84 parents and 84 adolescents consented, n=40 (20 parent-adolescent dyads) did not receive the intervention (reasons stated in Participant Flow section), resulting in data from 64 adolescents and 64 parents at baseline (as well as 4 providers)
| Age, Continuous(years) | Adolescent | Parent | Provider | Total |
|---|---|---|---|---|
| Mean | 15.0 ± 1.8 | — | — | 15.0 ± 1.8 |
| Sex: Female, Male(Participants) | Adolescent | Parent | Provider | Total |
|---|---|---|---|---|
| Female | 36 | 53 | — | 89 |
| Male | 28 | 11 | — | 39 |
| Race (NIH/OMB)(Participants) | Adolescent | Parent | Provider | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | — | — | 0 |
| Asian | 4 | — | — | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | — | — | 0 |
| Black or African American | 8 | — | — | 8 |
| White | 44 | — | — | 44 |
| More than one race | 8 | — | — | 8 |
| Unknown or Not Reported | 0 | — | — | 0 |
| Region of Enrollment(participants) | Adolescent | Parent | Provider | Total |
|---|---|---|---|---|
| United States | 64 | 64 | 4 | 132 |
| Diabetes Strengths and Resilience Measure - Adolescent(units on a scale) | Adolescent | Parent | Provider | Total |
|---|---|---|---|---|
| Mean | 37.0 ± 6.6 | — | — | 37.0 ± 6.6 |
| Diabetes Self-Management Profile - Adolescent Self-Report(units on a scale) | Adolescent | Parent | Provider | Total |
|---|---|---|---|---|
| Mean | 52.5 ± 10.3 | — | — | 52.5 ± 10.3 |
| Diabetes Self-Management Profile - Parent-report(units on a scale) | Adolescent | Parent | Provider | Total |
|---|---|---|---|---|
| Mean | — | 54.4 ± 9.2 | — | 54.4 ± 9.2 |
| Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency)(checks per day) | Adolescent | Parent | Provider | Total |
|---|---|---|---|---|
| Mean | 3.6 ± 1.4 | — | — | 3.6 ± 1.4 |
8 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Participants receive informed consent form and a profile of results from two surveys completed during intervention, other participant data not returned to participant
Supporting information: Icf
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