A Randomized Control Pilot Study to Examine the Effectiveness of Telehealth Occupation-Based Coaching for Families With a Child With Type 1 Diabetes

Design The research investigators plan to use a randomized control trial design with a small sample size (n=16) to gather pilot data. This pilot data will provide the foundation for a future full-scale clinical trial.

This study utilizes Occupation-Based-Coaching (OBC) via telehealth to improve quality of life of families and children diagnosed with type 1 diabetes living in rural communities. Occupation based coaching is an intervention founded on the principles of occupational performance coaching and has proven to be an effective intervention in family-centered practice. OBC is a strength-based approach that emphases collaboration with clients in goals setting and attainment to increase overall health and quality of life. Clients are the central focus of the intervention and generate their own strategies to address goals as part of the coaching process. In their role as coach, the therapists employ techniques such as reflective questioning and comments to support clients in identifying existing routines and rituals that impact goal attainment and to increase knowledge and access to resources that can promote improved caregiver quality of life after a child's diagnoses with T1D. Occupation based coaching can be divided into the following steps: "(1) setting goals, (2) exploring options, (3) planning action, (4) carrying out the plan, (5) checking performance, and (6) generalizing." An expert in occupation-based coaching will provide intervention protocol training to the research team. An intervention fidelity measure, providing more information about the intervention, is attached as an Addendum.

Procedure Participants will be recruited through use of social media platforms, ResearchMatch, snowball sampling /referrals, and Juvenile Diabetes Research Foundation outreach events. Written consent from the guardian, assent from children aged 7-12, and parental permission forms will be obtained prior to the beginning the study. Through simple randomization, 16 families (caregiver/child dyads) will be allocated into either the control group or the intervention group. Due to IRB regulations and ethics, the control group will receive the intervention after study completion. A research team member will then call the guardian to schedule the CGM training, evaluation, and the first intervention appointment (if in the intervention group). Each subsequent visit and post-evaluation will be scheduled the week prior.

Prior to starting the intervention, participants in the control and intervention group will receive training regarding continuous glucose monitor (CGM) from a certified diabetes educator. The CDE will deliver the training in a group setting as able (individual if needed due to scheduling or participant preference) via Zoom, the training will last approximately 60-90 minutes. If the participants were previously using a Dexcom, the training will likely be shorter at 30-60 minutes. The training will be followed by a two-week trial with the CGM to ensure comfort and competence using the CGM device.

After the trial period is concluded, the team evaluators (registered nurse, registered occupational therapist) will administer all assessments. The registered nurse will administer the Demographic Family Form (2-3 minutes) with the caregiver, WHO-QOL (10 minutes) with the caregiver, and provide directions for the at-home hemoglobin a1c testing (5 minutes) with the caregiver and child. Procedures for the hemoglobin a1c are outlined in an addendum. The occupational therapist evaluator will administer the Parental Scale of Competence (5 minutes) with the caregiver and Goal Attainment Scale (5-10 minutes) with the caregiver and child as appropriate. Time-in-Range will be read separately from the CGM application, and the certified diabetes educator will pull all data from the application. The CGM reads the child's blood glucose levels. Approximately 30 minutes total will be allocated for the evaluation. All evaluators are blinded to the group assignments to decrease risk of bias. The study participants will have access to the certified diabetes educator to ask questions about the CGM throughout the study.