Telehealth Family Coaching With Type 1 Diabetes

NCT04753099 | Completed

• 1 other identifier: Telehealth Coaching
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (5)

• Quality of Life survey to measure physical health, psychological health, social relationships, and environmental health.

  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).

  A change from baseline to 12 weeks

• family-centered participation goals

  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.

  A change from baseline to 12 weeks

• time-in-range

  continuous glucose monitor

  A change from baseline to 12 weeks

• hemoglobin a1c number

  biometric

  A change from baseline to 12 weeks

• parental competence with managing child's care

  Parenting Sense of Competence Scale. Parent's rate 17 items on a scale of 1-6 (1 meaning strongly disagree and 6 meaning strongly agree). A higher total score indicates a higher parenting sense of competency. There are no average scores or 'cut-off's' for this tool.

  A change from baseline to 12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Receives occupation-based coaching via telehealth

Behavioral: occupation-based coaching

Control

NO INTERVENTION

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

Interventions

occupation-based coaching BEHAVIORAL

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).

Also known as: family coaching

Intervention

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• child is currently receiving occupational therapy services

Sponsors & Collaborators

• Creighton University: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

Related Publications (4)

• Cason J, Behl D, Ringwalt S. Overview of States' Use of Telehealth for the Delivery of Early Intervention (IDEA Part C) Services. Int J Telerehabil. 2012 Dec 9;4(2):39-46. doi: 10.5195/IJT.2012.6105. eCollection 2012 Fall.

  PMID: 25945202 BACKGROUND

• Little LM, Pope E, Wallisch A, Dunn W. Occupation-Based Coaching by Means of Telehealth for Families of Young Children With Autism Spectrum Disorder. Am J Occup Ther. 2018 Mar/Apr;72(2):7202205020p1-7202205020p7. doi: 10.5014/ajot.2018.024786.

  PMID: 29426380 BACKGROUND

• Zylstra, S.E. (2013). Evidence for the use of telehealth in pediatric occupational therapy. Journal of Occupational Therapy, Schools, and Early Intervention, 6, 326-355.

  BACKGROUND

• Graham F, Rodger S, Ziviani J. Coaching parents to enable children's participation: an approach for working with parents and their children. Aust Occup Ther J. 2009 Feb;56(1):16-23. doi: 10.1111/j.1440-1630.2008.00736.x.

  PMID: 20854485 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Vanessa Jewell, PhD, OTR/L

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: February 15, 2021
• Study Start: October 9, 2020
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)