Diabetes in Adolescence, Social Needs, Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALTailored 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).
BEHAVIORALUniversal 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.
BEHAVIORALText 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.
BEHAVIORALCommunity Health Workers (CHW)
Participants will be assigned a trained CHW to support connection with resources to address HRSN.
Sponsors
University of Pittsburgh
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention: Health-Related Social Needs Screener | at 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 Needs | 1-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 Needs | at 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 Needs | 3 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 Needs | 3 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 | 1-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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related social needs: Food Insecurity | Baseline, 3 months, 6 months | Six-Item Standard Measure from USDA Economic Research Service; completed by adolescents and caregivers. Food insecurity assessment includes 5 questions assessing presence and frequency of experiences consistent with food insecurity; responses include "often," "sometimes," or "never" as well as "yes" and "no." "Often," "sometimes," or "never" are scored as 1, 2, and 3 respectively, with yes=1 and no=2. The sum of affirmative responses ("often," "sometimes," "yes") is the raw score, with 0-1 indicating high or marginal food security, 2-4 low food security, 5-6 very low food security. Percentage of positive responses (food insecurity: marginal, low, or very low food security) will be reported. |
| Health-related social needs: Housing Insecurity | Baseline, 3 months, 6 months | 3 items from the PhenX repository; completed by adolescents and caregivers. Housing is assessed using 3 questions about living situation, stress related to rent/mortgage, and problems with housing; responses describing worry about losing a place to live or not having a steady place to live, as well as problems with housing, or always, usually, or sometimes worrying about not having enough money to pay rent or mortgage indicate positive housing insecurity. Percentage of positive responses (housing insecurity) will be reported. |
| Health-related social needs: Transportation Insecurity | Baseline, 3 months, 6 months | 1 item from the PhenX repository; completed by adolescents and caregivers to assess lack of reliable transportation for medical appointments (yes/no). Percentage of affirmative responses (transportation insecurity) will be reported. |
| Hemoglobin A1C | Baseline, 3 months, 6 months | As measured during clinic visit; for adolescents only. Reported as %. |
| Body Mass Index | Baseline, 3 months, 6 months | As measured at clinic visits; for adolescents only. Reported as kg/m2. |
Countries
United States
Contacts
CONTACTMary Ellen Vajravelu, MD MSHP
CONTACTMaya I Ragavan, MD MPH MS
PRINCIPAL_INVESTIGATORMary Ellen Vajravelu, MD MSHP
University of Pittsburgh
PRINCIPAL_INVESTIGATORMaya I Ragavan, MD MPH MS
University of Pittsburgh
Outcome results
None listed