Telehealth Family Coaching With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Telehealth is a delivery format that shows promise, and occupation-based coaching (OBC) is
      one intervention that can be delivered via telehealth. OBC is a collaborative coaching model
      with the therapist and the family (caregiver and child) that has been shown to improve
      positive child-caregiver interactions, caregiver competence with managing child health
      maintenance tasks, and improve engagement in meaningful everyday tasks (such as health
      maintenance tasks, self-care, and social participation). The goal of this pilot study is to
      improve child health outcomes and family quality of life for young children diagnosed with
      type 1 diabetes. Specifically, this pilot randomized control trial will provide valuable
      information about the preliminary effectiveness of occupation-based coaching (OBC) via
      telehealth to improve the quality of life of families and children diagnosed with type 1
      diabetes (T1D). It is hypothesized that OBC is an effective intervention that can be
      delivered to T1D families living in rural communities via telehealth methods.
    

Detailed description: 
      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.

      After the two-week trial with the CGM, the families will begin the 12-weeks of either
      receiving the intervention/OBC or control/standard care. During the 12 weeks, the control
      group will receive standard care (Table 1) for a child with type 1 diabetes continued by
      their current medical provider.

      The intervention group will receive occupation-based-coaching via telehealth, along with
      standard care. Individual intervention sessions will be conducted 1 time per week for a
      1-hour period by a licensed occupational therapy practitioner and /or student supervised by a
      licensed occupational therapy practitioner. The intervention will be delivered via
      telehealth, utilizing a private room equipped with telehealth technology. Telehealth
      intervention will be provided through Zoom for HealthCare, a Health Insurance Portability and
      Accountability Act of 1996 (HIPAA) compliant video platform. Prior to each session, families
      will receive an email with a link to connect to the teleconference and a text reminder the
      day before the scheduled session. After completion of a 12-week intervention period, outcome
      measures will be re-administered by the nurse and/or occupational therapy practitioner, who
      remains blinded to participants' group allocation. All sessions will be recorded via Zoom and
      saved on the research computer. The recorded sessions will be sent to rev.com or other
      comparable transcription service for transcription. The evaluators will then code the
      transcriptions for intervention fidelity.

      A research team evaluator will administer all outcome measures and will be blinded to the
      intervention and control group to ensure rigor and avoid bias. All family member participants
      will be given a unique, anonymous identifier to maintain confidentiality. The research team
      will store all documents and data in a shared OneDrive (a secure cloud drive) that is only
      accessible to the research team and will keep the data for 3 years after study completion,
      per IRB guidelines. The research team completed all CITI training modules and are received
      additional training on adverse and unexpected events from the IRB office prior to starting
      the study. The researchers will immediately report any adverse or unexpected events to the
      IRB office and fill out the appropriate forms.
    

Intervention name(s): occupation-based coaching
Intervention type(s): Behavioral
Intervention description(s): Occupation based coaching is an intervention 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"(Little et al., 2018, p.2).
Other intervention name(s): family coaching
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment