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

NCT02510664 | Completed Results

• 2 other identifiers: H-348571K12DK097696
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Adolescence; Adherence

Outcome Measures

Primary Outcomes (5)

• Feasibility of Study Design

  Measured by percent of recruited families that enrolled in study

  Immediately following Enrollment (Baseline)

• Feasibility of Study Design

  Measured by percent of enrolled participants who receive full dose

  6-8 months after enrollment (follow-up timepoint)

• Feasibility of Study Design

  Measured by time to complete intervention in months since enrollment in study.

  6-8 months after enrollment (follow-up timepoint)

• Feasibility of Study Design

  Measured by percent of participants who provided complete data from all questionnaires.

  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.

  6-8 months after enrollment (follow-up timepoint)

Secondary Outcomes (12)

• Diabetes Strengths

  3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)

• Diabetes Self-Management Profile - Parent-report

  3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)

• Diabetes Self-Management Profile - Adolescent-report

  6-8 months after enrollment (follow-up timepoint)

• Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency)

  6-8 months after enrollment (follow-up timepoint)

• Glycemic Control

  6-8 months after enrollment (follow-up timepoint)

Study Arms (1)

Intervention

EXPERIMENTAL

There is no control/comparator group for this pilot study - all participants receive the intervention

Behavioral: Diabetes Strengths Study

Interventions

Diabetes Strengths Study BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Youth type 1 diabetes diagnosis for at least 12 months, to allow ample opportunity for adjustment to diabetes management
• Youth and parent fluency in written and spoken English because assessment measures are not available in other languages.

You may not qualify if:

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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Hilliard ME, Eshtehardi SS, Minard CG, Wheat S, Gunn S, Sanders C, Klenk R, Anderson BJ. Featured Article: Strengths-Based, Clinic-Integrated Nonrandomized Pilot Intervention to Promote Type 1 Diabetes Adherence and Well-Being. J Pediatr Psychol. 2019 Jan 1;44(1):5-15. doi: 10.1093/jpepsy/jsy051.

  PMID: 29982765 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Marisa Hilliard PhD, Principal Investigator
• Organization: Baylor College of Medicine

marisa.hilliard@bcm.edu

832-824-7209

Study Officials

• Marisa E Hilliard, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 29, 2015
• Study Start: July 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

US (1)