Pilot-Testing Strategies to Improve Outcomes for Youth With Type 2 Diabetes by Addressing Health-Related Social Needs (ONWARD)

University of Pittsburgh

Status: Begins enrollment in 1 month

Conditions: Social Needs; Diabetes in Adolescence; Type 2 Diabetes

Treatments: Behavioral: Tailored Resources; Behavioral: Community Health Workers (CHW); Behavioral: Text Messages; Behavioral: Universal Empowerment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07216118

1R01DK142766-01 (U.S. NIH Grant/Contract)

STUDY25030030

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Adolescent-Caregiver Dyads will be recruited together.

Adolescent 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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104 participants in 4 patient groups

Tailored Resources and Text Messages

Experimental group

Description:

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.

Treatment:

Behavioral: Text Messages

Behavioral: Tailored Resources

Tailored Resources and Community Health Worker

Experimental group

Description:

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.

Treatment:

Behavioral: Community Health Workers (CHW)

Behavioral: Tailored Resources

Universal Empowerment and Text Messages

Experimental group

Description:

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.

Treatment:

Behavioral: Universal Empowerment

Behavioral: Text Messages

Universal Empowerment and Community Health Worker

Experimental group

Description:

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.

Treatment:

Behavioral: Universal Empowerment

Behavioral: Community Health Workers (CHW)