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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial

Authors: Ann-Marie Rosland, John D. Piette, Ranak Trivedi, Eve A. Kerr, Shelley Stoll, Adam Tremblay, Michele Heisler

Published in: Trials | Issue 1/2018

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Abstract

Background

Most adults with diabetes who are at high risk for complications have family or friends who are involved in their medical and self-care (“family supporters”). These family supporters are an important resource who could be leveraged to improve patients’ engagement in their care and patient health outcomes. However, healthcare teams lack structured and feasible approaches to effectively engage family supporters in patient self-management support. This trial tests a strategy to strengthen the capacity of family supporters to help adults with high-risk diabetes engage in healthcare, successfully enact care plans, and lower risk of diabetes complications.

Methods/design

We will conduct a randomized trial evaluating the CO-IMPACT (Caring Others Increasing EnageMent in Patient Aligned Care Teams) intervention. Two hunded forty adults with diabetes who are at high risk for diabetes complications due to poor glycemic control or high blood pressure will be randomized, along with a family supporter (living either with the patient or remotely), to CO-IMPACT or enhanced usual primary care for 12 months. CO-IMPACT provides patient-supporter dyads: it provides one coaching session addressing supporter techniques for helping patients with behavior change motivation, action planning, and proactive communication with healthcare providers; biweekly automated phone calls to prompt dyad action on new patient health concerns; phone calls to prompt preparation for patients’ primary care visits; and primary care visit summaries sent to both patient and supporter. Primary outcomes are changes in patient activation, as measured by the Patient Activation Measure-13, and change in 5-year cardiac event risk, as measured by the United Kingdom Prospective Diabetes Study cardiac risk score for people with diabetes. Secondary outcomes include patients’ diabetes self-management behaviors, diabetes distress, and glycemic and blood pressure control. Measures among supporters will include use of effective support techniques, burden, and distress about patient’s diabetes care.

Discussion

If effective in improving patient activation and diabetes management, CO-IMPACT will provide healthcare teams with evidence-based tools and techniques to engage patients’ available family or friends in supporting patient self-management, even if they live remotely. The core skills addressed by CO-IMPACT can be used by patients and their supporters over time to respond to changing patient health needs and priorities.

Trial registration

ClinicalTrials.gov, NCT02328326. Registered on 31 December 2014.
Appendix
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Metadata
Title
Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial
Authors
Ann-Marie Rosland
John D. Piette
Ranak Trivedi
Eve A. Kerr
Shelley Stoll
Adam Tremblay
Michele Heisler
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2785-2

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