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Purpose

The goal of this clinical trial is to pilot test different strategies to address health related social needs (HRSN) experienced by adolescent and young adult patients with type 2 diabetes and their families. The main questions it aims to answer are: - How feasible are the strategies? - How acceptable are the strategies? - How reliably and consistently can the strategies be implemented? Participants will: Attend regularly scheduled diabetes clinic visits. Complete surveys and interviews. Be connected to community resources and organizations to help address HRSN.

Conditions

Eligibility

Eligible Ages
Over 13 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age 13 to 22 years old - known diagnosis of type 2 diabetes - followed clinically at UPMC Children's Hospital of Pittsburgh - able to provide assent/consent Caregiver Inclusion Criteria: - Adult (18 years or older) identifying as a primary caretaker of an adolescent or young adult with type 2 diabetes - Has an adolescent/young adult who agrees to participate in the study - able to provide consent

Exclusion Criteria

  • Inability to complete study questionnaires in English

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tailored Resources and Text Messages 		Tailored Resources AND Text Messages: Tailored Resources: Participants will be offered resource lists and warm referrals specific to health-related social needs (HRSN) on a screener. Their clinical team will be sent screener results and asked to talk about and address HRSN at the visit without additional guidance. Participants will be offered physical resources related to disclosed HRSN (e.g., food box for food insecurity). Text Messages: Participants will receive text messages once per month for 3 months. Messages will state that community-based resources to address HRSN are available if needed, with a link to opt-in to resource lists and warm referral links. Messages will include contact information for the study and clinical teams for optional HRSN discussion. Community Health Worker will not be assigned.
  • Behavioral: Tailored Resources
    Participants will be offered resource lists and warm referrals specific to health-related social needs (HRSN) on a screener. Their clinical team will be sent screener results and asked to talk about and address HRSN at the visit without additional guidance. Participants will be offered physical resources related to disclosed HRSN (e.g., food box for food insecurity).
    Other names:
    • Tailored
  • Behavioral: Text Messages
    Participants will receive text messages once per month for 3 months. Messages will state that community-based resources to address health-related social needs (HRSN) are available if needed, with a link to opt-in to resource lists and warm referral links. Messages will include contact information for the study and clinical teams for optional HRSN discussion. Community Health Worker will not be assigned.
    Other names:
    • Text Only
Experimental
Tailored Resources and Community Health Worker 		Tailored Resources AND Community Health Worker (CHW): Tailored Resources: Participants will be offered resource lists and warm referrals specific to health-related social needs (HRSN) on a screener. Their clinical team will be sent screener results and asked to talk about and address HRSN at the visit without additional guidance. Participants will be offered physical resources related to disclosed HRSN. CHW: Participants will be assigned a trained CHW to support connection with resources to address HRSN.
  • Behavioral: Tailored Resources
    Participants will be offered resource lists and warm referrals specific to health-related social needs (HRSN) on a screener. Their clinical team will be sent screener results and asked to talk about and address HRSN at the visit without additional guidance. Participants will be offered physical resources related to disclosed HRSN (e.g., food box for food insecurity).
    Other names:
    • Tailored
  • Behavioral: Community Health Workers (CHW)
    Participants will be assigned a trained CHW to support connection with resources to address HRSN.
    Other names:
    • CHW
Experimental
Universal Empowerment and Text Messages 		Assigned to Universal Empowerment AND Text Messages: Universal Empowerment: Regardless of disclosed health-related social needs (HRSN), participants will be offered physical resources and the opportunity to meet with a social worker. In place of screening results, the clinical team will be sent a message requesting that, when seeing the patient in clinic, they use the provided, easily accessible empowering script about HRSN. Text Messages: Participants randomized to text message will receive text messages once per month for 3 months. Messages will state that community-based resources to address HRSN are available if needed, with a link to opt-in to resource lists and warm referral links. Messages will include contact information for the study and clinical teams for optional HRSN discussion. Community Health Worker will not be assigned to participants.
  • Behavioral: Universal Empowerment
    Regardless of disclosed health-related social needs (HRSN), participants will be offered resource lists and warm referral links for food, housing, and transportation needs. At clinic visit, all will be offered physical resources and the opportunity to meet with a social worker. In place of screening results, the clinical team will be sent a message requesting that, when seeing the patient in clinic, they use the provided, easily accessible empowering script about HRSN.
    Other names:
    • Universal
  • Behavioral: Text Messages
    Participants will receive text messages once per month for 3 months. Messages will state that community-based resources to address health-related social needs (HRSN) are available if needed, with a link to opt-in to resource lists and warm referral links. Messages will include contact information for the study and clinical teams for optional HRSN discussion. Community Health Worker will not be assigned.
    Other names:
    • Text Only
Experimental
Universal Empowerment and Community Health Worker 		Universal Empowerment AND Community Health Worker (CHW): Universal Empowerment: Regardless of disclosed health-related social needs (HRSN), participants will be offered physical resources and the opportunity to meet with a social worker. In place of screening results, the clinical team will be sent a message requesting that, when seeing the patient in clinic, they use the provided, easily accessible empowering script about HRSN. CHW: Participants will be assigned a trained CHW to support connection with resources to address HRSN.
  • Behavioral: Universal Empowerment
    Regardless of disclosed health-related social needs (HRSN), participants will be offered resource lists and warm referral links for food, housing, and transportation needs. At clinic visit, all will be offered physical resources and the opportunity to meet with a social worker. In place of screening results, the clinical team will be sent a message requesting that, when seeing the patient in clinic, they use the provided, easily accessible empowering script about HRSN.
    Other names:
    • Universal
  • Behavioral: Community Health Workers (CHW)
    Participants will be assigned a trained CHW to support connection with resources to address HRSN.
    Other names:
    • CHW

Recruiting Locations

UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
Contact:
Mary Ellen Vajravelu, MD MSHP
4126926533

More Details

NCT ID
NCT07216118
Status
Recruiting
Sponsor
University of Pittsburgh

Study Contact

Mary Ellen Vajravelu, MD MSHP
412-692-6533
maryellen.vajravelu@pitt.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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