Pilot Study for Improving Outcomes in Youth with Type 2 Diabetes
This study is looking at different ways to help young people (ages 13-22) with type 2 diabetes and their families. It focuses on addressing health-related social needs (HRSN), which are things like access to food, housing, and transportation that can affect health. The study will test several approaches: providing tailored resources based on specific needs, offering universal resources to everyone, sending supportive text messages, and connecting families with Community Health Workers (CHW) who can help find resources. The main goal is to see how practical and well-received these strategies are. You would attend regular clinic visits and complete surveys and interviews.
- Study design
- This interventional study plans to enroll 104 participants. It is a pilot study, meaning it's testing new approaches to see how well they work.
- What's involved
- Participants will attend regularly scheduled diabetes clinic visits and complete surveys and interviews. They will also be connected to community resources.
- Compensation
- Not stated in the trial record.
- Follow-up
- Acceptability of interventions will be measured at baseline, 1-week after baseline, and 3 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pilot-Testing Strategies to Improve Outcomes for Youth With Type 2 Diabetes by Addressing Health-Related Social Needs
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Mary Ellen Vajravelu, MD MSHP · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
- Maya I Ragavan, MD MPH MS · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Acceptability of Intervention: Health-Related Social Needs Screenerat baseline clinic visit
4-item Acceptability of Intervention Measure; completed by all adolescents and caregivers. Questions are specific to acceptability of the screening questionnaire used to assess health-related social needs, with responses ranging from completely disagree to completely agree (5-point scale). A mean of 4 or higher indicates acceptability.
- Acceptability of Intervention: Tailored Approach to Address Health-Related Social Needs1-week after baseline; 3 months
4-item Acceptability of Intervention Measure; completed by adolescents and caregivers assigned to arms using a tailored approach (not universal empowerment). Questions are specific to acceptability of the tailored approach used to address health-related social needs, with responses ranging from completely disagree to completely agree (5-point scale). A mean of 4 or higher indicates acceptability.
- Acceptability of Intervention: Universal Empowerment Approach to Address Health-Related Social Needsat baseline visit; 1-week after baseline; 3 months
4-item Acceptability of Intervention Measure; completed by adolescents and caregivers assigned to arms using a universal empowerment approach (not tailored approach). Questions are specific to acceptability of the universal empowerment approach used to address health-related social needs, with responses ranging from completely disagree to completely agree (5-point scale). A mean of 4 or higher indicates acceptability.
- Acceptability of Intervention: Text Messages to Address Health-Related Social Needs3 months
4-item Acceptability of Intervention Measure; completed by adolescents and caregivers assigned to arms using text messages without community health workers to support resource connection. Questions are specific to acceptability of the text messages without community health worker approach used to address health-related social needs, with responses ranging from completely disagree to completely agree (5-point scale). A mean of 4 or higher indicates acceptability.
- Acceptability of Intervention: Community Health Workers to Address Health-Related Social Needs3 months
4-item Acceptability of Intervention Measure; completed by adolescents and caregivers assigned to arms using text messages with community health workers to support resource connection. Questions are specific to acceptability of community health workers in addition to text messages to address health-related social needs, with responses ranging from completely disagree to completely agree (5-point scale). A mean of 4 or higher indicates acceptability.
- Fidelity of Intervention1-week after baseline; 3 months; 6 months
Investigator developed survey around receipt of intervention components including resources requested and used, community health worker interactions, and text message receipt; completed by adolescents and caregivers in all arms. Frequency and types of resources used, as well as community organizations with which respondents interacted will be reported. Frequency and duration of contact with community health workers will be reported for those assigned to arms using community health workers.