About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Inability to complete study questionnaires in English
Trial design
Factorial
Treatments tested in this trial
Tailored Resources
BehavioralParticipants 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).
Universal Empowerment
BehavioralRegardless 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.
Text Messages
BehavioralParticipants 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.
Community Health Workers (CHW)
BehavioralParticipants will be assigned a trained CHW to support connection with resources to address HRSN.
Treatment groups
Trial outcomes
Primary outcomes
Acceptability of Intervention: Health-Related Social Needs Screener
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
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
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
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.
Secondary outcomes
Health-related social needs: Food Insecurity
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
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
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
As measured during clinic visit; for adolescents only. Reported as %.
Other outcomes
Physical activity
PACE questionnaire is a 2-item survey to evaluate frequency of engagement in at least 60 minutes of daily physical activity over the past 7 days and a typical week. Higher numbers of days indicates greater adherence to physical activity guidelines for adolescents. Administered to adolescent participants only.
Health Literacy
BRIEF Health Literacy Survey is a 4-item questionnaire with 5 response options each ranging from "not at all" to "extremely." Responses are totaled for a possible score of 4-20, with higher scores corresponding to higher health literacy.
Mood
The Mood and Feelings Questionnaire: Short Version will be used to evaluate mood in adolescent and caregiver participants. This 13-item survey includes responses of "not true", "sometimes", and "true", scored as 0, 1, and 2. Total scores range from 0-26, with higher scores indicating higher severity.
Social Support
Multidimensional Scale of Perceived Support Scale (Zimet, Dahlem, Zimet, Farley, 1988); completed by adolescents and caregivers. The 12-item survey includes a 7-item scale of response from "very strongly disagree" (1) to "very strongly agree" (7). There are 3 subscales to indicate significant other, family, and friends support. Responses will be averaged by subscale, with higher numbers indicating greater support. A total score (average of 12 response) will be reported.
Sponsors and contacts
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University of Pittsburgh
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator