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

NCT ID: NCT02510664

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-08-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Diabetes Strengths Study

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Marisa Hilliard

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marisa E Hilliard, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 29982765 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1K12DK097696

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-34857

Identifier Type: -

Identifier Source: org_study_id