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Diabetes Strengths Study - Pilot of Provider-delivered Strengths-based Intervention (DSS)

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ClinicalTrials.gov Identifier: NCT02510664
Recruitment Status : Completed
First Posted : July 29, 2015
Results First Posted : February 24, 2020
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Marisa Hilliard, 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: Diabetes Strengths Study Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Promoting Resilience in Youth With Type 1 Diabetes: Pilot of Strengths-Based Family Intervention to Improve Diabetes Outcomes (Diabetes Strengths Study)
Study Start Date : July 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
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.




Primary Outcome Measures :
  1. Feasibility of Study Design [ Time Frame: Immediately following Enrollment (Baseline) ]
    Measured by percent of recruited families that enrolled in study

  2. Feasibility of Study Design [ Time Frame: 6-8 months after enrollment (follow-up timepoint) ]
    Measured by percent of enrolled participants who receive full dose

  3. Feasibility of Study Design [ Time Frame: 6-8 months after enrollment (follow-up timepoint) ]
    Measured by time to complete intervention in months since enrollment in study.

  4. Feasibility of Study Design [ Time Frame: 6-8 months after intervention begins (immediately following second study visit) ]
    Measured by percent of participants who provided complete data from all questionnaires.

  5. Acceptability: Number of Participants That Felt the Intervention Was Well-Received [ Time Frame: 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 :
  1. Diabetes Strengths [ Time Frame: 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.

  2. Diabetes Self-Management Profile - Parent-report [ Time Frame: 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.

  3. Diabetes Self-Management Profile - Adolescent-report [ Time Frame: 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.

  4. Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency) [ Time Frame: 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.

  5. Glycemic Control [ Time Frame: 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.

  6. Problem Areas in Diabetes - Teen [ Time Frame: 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.

  7. Diabetes Burden - Problem Areas in Diabetes - Parent-report [ Time Frame: 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.

  8. Diabetes-related Family Conflict (Parent-report) [ Time Frame: 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.

  9. Diabetes-related Family Conflict (Adolescent Report) [ Time Frame: 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.

  10. Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report [ Time Frame: 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.

  11. Adolescent-provider Relationship - Adolescent-report [ Time Frame: 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.

  12. Provider-family Relationship, Provider-report [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510664


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Marisa E Hilliard, PhD Baylor College of Medicine
  Study Documents (Full-Text)

Documents provided by Marisa Hilliard, Baylor College of Medicine:
Additional Information:
Publications of Results:
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Responsible Party: Marisa Hilliard, Assistant Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02510664    
Other Study ID Numbers: H-34857
1K12DK097696 ( U.S. NIH Grant/Contract )
First Posted: July 29, 2015    Key Record Dates
Results First Posted: February 24, 2020
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants receive informed consent form and a profile of results from two surveys completed during intervention, other participant data not returned to participant
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Receive informed consent form upon signing, and receive profile of results from 2 intervention surveys at the intervention sessions
Access Criteria: All participants receive informed consent form and survey result profile
Keywords provided by Marisa Hilliard, Baylor College of Medicine:
Adolescence
Adherence
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases