Diabetes Strengths Study - Pilot of Provider-delivered Strengths-based Intervention

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Diabetes Strengths Study

• Registration Number: NCT02510664
• Lead Sponsor: Baylor College of Medicine

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-29
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2019-07-09
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-11
• Last Update Submitted: 2020-02-11
• Results First Posted: 2020-02-24
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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.

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Exclusion Criteria

(1) Presence of a serious mental illness or developmental disability in youth or parent that would impede participation would exclude eligibility.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Diabetes Strengths Study	There is no control/comparator group for this pilot study - all participants receive the intervention

Primary Outcome Measures

Name	Time	Method
Feasibility of Study Design	6-8 months after intervention begins (immediately following second study visit)	Measured by percent of participants who provided complete data from all questionnaires.
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 Outcome Measures

Name	Time	Method
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 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.
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.
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-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.
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States