Pilot Study of Brief Intervention to Support Diabetes Health-Related Quality of Life

Feasibility of conducting a research study about this intervention will be measured by percentage of eligible participants who consent to the study, complete questionnaires, and receive the full intervention dose. These outcomes will be calculated based on recruitment and program delivery tracking conducted by study staff

Participants will complete brief surveys at study completion that assess their experiences with the intervention, including helpfulness of conversations, value of time spent, overall acceptability of program, and recommendations for improvement. Items will be rated using a Likert-scale, with higher scores indicating higher satisfaction with each item.

Participants will complete the age- and respondent-appropriate version of the Type 1 Diabetes and Life (T1DAL) measure. Psychometric data regarding the validity and reliability of the pediatric, adult, and parent/partner versions of the T1DAL are published. Total scores are on a 100-point scale, with higher scores indicating better quality of life.

This is the only measure that will also be collected at the mid-point (before 2nd visit) between the two intervention sessions. Participant responses on the baseline and midpoint T1DAL measures will be automatically scored (per an algorithm designed by the study investigator team) and used to generate a quality of life profile that the CDCES will use in each intervention session.

Participants will complete the age- and respondent-appropriate version of the Problem Areas in Diabetes (PAID) scale (children, adolescents, and parents) or the Diabetes Distress Scale (adults and partners). Higher scores on each measure indicate more distress.

Participants will complete the Self-Care Inventory Revised. Higher scores indicate higher adherence/more engagement in diabetes self-management behaviors. For youth under age 12, parents will complete this measure about the child's self-management behaviors because this measure has not been validated for self-report use by children. Parents of youth age 12 or older and partners of adults will not complete any measures of self-management behavior.

Point of care HbA1c values documented by the medical team at each clinic visit during which an intervention session takes place, plus the following clinic visit (3-6 months after the second intervention session) will be collected from the electronic health record, to assess change in glycemic outcomes. For participants in the primary care group, participants will self-report the date and value of their most recent HbA1c at each time point. They will be asked to upload a photo/PDF of documentation of their HbA1c value (e.g., lab results printout) if available. Participants in the primary care group will also be asked to complete a research home fingerstick HbA1c kit. Higher HbA1c indicates higher average blood glucose values over the previous 2-3 months, which represents poorer glycemic control.

When available for participants who use a continuous glucose monitor (CGM), 14 days' of CGM data will be downloaded at each time point by the study teams to calculate glucose time-in-range as an additional index of glycemic control. Higher time-in-range is an indicator of better glycemic control.