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Telehealth Family Coaching With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04753099
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : February 15, 2021
DexCom, Inc.
Information provided by (Responsible Party):
Vanessa Jewell, Creighton University

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Behavioral: occupation-based coaching Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Control Pilot Study to Examine the Effectiveness of Telehealth Occupation-Based Coaching for Families With a Child With Type 1 Diabetes
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Intervention
Receives occupation-based coaching via telehealth
Behavioral: occupation-based coaching
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 Name: family coaching

No Intervention: Control
No intervention Will receive the occupation-based coaching via telehealth after the 12-weeks

Primary Outcome Measures :
  1. Quality of Life survey to measure physical health, psychological health, social relationships, and environmental health. [ Time Frame: A change from baseline to 12 weeks ]
    This survey is a 26-item instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health. This survey is also contains quality of life and general health items. Each individual item is scored from 1 to 5 on a response scale (1 being low and 5 being high).

  2. family-centered participation goals [ Time Frame: A change from baseline to 12 weeks ]
    Goal Attainment Scale measures whether goals are met or not on a scale of (-2 being much worse than the current situation to +2 being much better than the current situation.

  3. time-in-range [ Time Frame: A change from baseline to 12 weeks ]
    continuous glucose monitor

  4. hemoglobin a1c number [ Time Frame: A change from baseline to 12 weeks ]

  5. parental competence with managing child's care [ Time Frame: A change from baseline to 12 weeks ]
    Parenting Sense of Competence Scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • caregivers and children diagnosed with type 1 diabetes
  • one hour commute to pediatric endocrinology office
  • reside in NE, IA, MN, or CO
  • caregiver must be 19 years old or older

Exclusion Criteria:

  • child is currently receiving occupational therapy services

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04753099

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Contact: Vanessa Jewell, PhD, OTR/L 402-280-5946

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United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68178
Contact: Vanessa Jewell, PhD, OTR/L    402-280-5946   
Sponsors and Collaborators
Creighton University
DexCom, Inc.
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Principal Investigator: Vanessa Jewell, PhD, OTR/L Creighton University
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Responsible Party: Vanessa Jewell, Principal Investigator, Creighton University Identifier: NCT04753099    
Other Study ID Numbers: Telehealth Coaching
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases