Optimizing Navigation for Wellness And Resources Utilization in Youth With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Pittsburgh
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Acceptability of Intervention: Health-Related Social Needs Screener
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
Arms & Interventions
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.
Intervention: Tailored Resources (Behavioral)
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.
Intervention: Text Messages (Behavioral)
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.
Intervention: Tailored Resources (Behavioral)
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.
Intervention: Community Health Workers (CHW) (Behavioral)
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.
Intervention: Universal Empowerment (Behavioral)
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.
Intervention: Text Messages (Behavioral)
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.
Intervention: Universal Empowerment (Behavioral)
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.
Intervention: Community Health Workers (CHW) (Behavioral)
Outcomes
Primary Outcomes
Acceptability of Intervention: Health-Related Social Needs Screener
Time Frame: 1-week after baseline
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 Needs
Time Frame: 1-week after baseline; 3 months; 6 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.
Feasibility of Intervention: Health-Related Social Needs Screener
Time Frame: 1-week after baseline
4-item Feasibility of Intervention Measure; completed by all adolescents and caregivers. Questions are specific to feasibility 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 feasibility.
Feasibility of Intervention: Tailored Approach to Address Health-Related Social Needs
Time Frame: 1-week after baseline; 3 months; 6 months
4-item Feasibility of Intervention Measure; completed by adolescents and caregivers assigned to arms using a tailored approach (not universal empowerment). Questions are specific to feasibility 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 feasibility.
Acceptability of Intervention: Universal Empowerment Approach to Address Health-Related Social Needs
Time Frame: 1-week after baseline; 3 months; 6 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.
Feasibility of Intervention: Community Health Workers to Address Health-Related Social Needs
Time Frame: 1-week after baseline; 3 months; 6 months
4-item Feasibility 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 feasibility 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 feasibility.
Feasibility of Intervention: Universal Empowerment Approach to Address Health-Related Social Needs
Time Frame: 1-week after baseline; 3 months; 6 months
4-item Feasibility of Intervention Measure; completed by adolescents and caregivers assigned to arms using a universal empowerment approach (not tailored approach). Questions are specific to feasibility 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 feasibility.
Acceptability of Intervention: Text Messages to Address Health-Related Social Needs
Time Frame: 1-week after baseline; 3 months; 6 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.
Feasibility of Intervention: Text Messages to Address Health-Related Social Needs
Time Frame: 1-week after baseline; 3 months; 6 months
4-item Feasibility 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 feasibility 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 feasibility.
Acceptability of Intervention: Community Health Workers to Address Health-Related Social Needs
Time Frame: 1-week after baseline; 3 months; 6 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 Intervention
Time Frame: 1-week after baseline; 3 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.
Secondary Outcomes
- Health-related social needs: Food Insecurity(Baseline, 3 months, 6 months)
- Health-related social needs: Housing Insecurity(Baseline, 3 months, 6 months)
- Health-related social needs: Transportation Insecurity(Baseline, 3 months, 6 months)
- Connection with community health workers (CHW)(Baseline, 3 months, 6 months)
- Hemoglobin A1C(Baseline, 3 months, 6 months)
- Body Mass Index(Baseline, 3 months, 6 months)
- Diet quality(Baseline, 3 months, 6 months)
- Diabetes distress(Baseline, 3 months, 6 months)
- Medication adherence(Baseline, 3 months, 6 months)
- Diabetes self-management(Baseline, 3 months, 6 months)
- Social Support(Baseline, 3 months, 6 months)
- Trustworthiness of Community Health Workers (CHW)(Baseline, 3 months, 6 months)
- Trustworthiness of Healthcare System(Baseline, 3 months, 6 months)
Investigators
Mary Ellen Vajravelu, MD
Assistant Professor
University of Pittsburgh