Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Nov:98:106157.
doi: 10.1016/j.cct.2020.106157. Epub 2020 Sep 21.

Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial

Elizabeth A Kobe  1 , David Edelman  2 , Phillip E Tarkington  3 , Hayden B Bosworth  4 , Matthew L Maciejewski  4 , Karen Steinhauser  5 , Amy S Jeffreys  5 , Cynthia J Coffman  6 , Valerie A Smith  4 , Elizabeth M Strawbridge  5 , Steven T Szabo  7 , Shivan Desai  3 , Mary P Garrett  8 , Theresa C Wilmot  8 , Teresa J Marcano  3 , Donna L Overby  3 , Glenda A Tisdale  3 , Melissa Durkee  9 , Susan Bullard  9 , Moahad S Dar  10 , Amy C Mundy  3 , Janette Hiner  3 , Sonja K Fredrickson  3 , Nadya T Majette Elliott  5 , Teresa Howard  5 , Deborah H Jeter  3 , Susanne Danus  5 , Matthew J Crowley  11
Affiliations

Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial

Elizabeth A Kobe et al. Contemp Clin Trials. 2020 Nov.

Abstract

Background: Persistent poorly-controlled type 2 diabetes mellitus (PPDM), or maintenance of a hemoglobin A1c (HbA1c) ≥8.5% despite receiving clinic-based diabetes care, contributes disproportionately to the national diabetes burden. Comprehensive telehealth interventions may help ameliorate PPDM, but existing approaches have rarely been designed with clinical implementation in mind, limiting use in routine practice. We describe a study testing a novel telehealth intervention that comprehensively targets clinic-refractory PPDM, and was explicitly developed for practical delivery using existing Veterans Health Administration (VHA) clinical infrastructure.

Methods: Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM) is an ongoing randomized controlled trial comparing two 12-month interventions: 1) standard VHA Home Telehealth (HT) telemonitoring/care coordination; or 2) the PRACTICE-DM intervention, a comprehensive HT-delivered intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. The primary outcome is HbA1c. Secondary outcomes include diabetes distress, self-care, self-efficacy, weight, depressive symptoms, implementation barriers/facilitators, and costs. We hypothesize that the PRACTICE-DM intervention will reduce HbA1c by >0.6% versus standard HT over 12 months.

Results: Enrollment for this ongoing trial concluded in January 2020; 200 patients were randomized (99 to standard HT and 101 to the PRACTICE-DM intervention). The cohort has a mean age of 58 and is 23% female and 72% African American. Mean baseline HbA1c and BMI were 10.2% and 34.8 kg/m2.

Conclusions: Because it comprehensively targets factors underlying PPDM using existing clinical infrastructure, the PRACTICE-DM intervention may be well suited to lower the complications and costs of PPDM in routine practice.

Keywords: Comparative effectiveness; Health services research; Poorly controlled diabetes; Telehealth intervention.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
PRACTICE-DM intervention theoretical framework.
Fig. 2
Fig. 2
PRACTICE-DM intervention components.
Fig. 3
Fig. 3
PRACTICE-DM participant recruitment and follow-up.
See this image and copyright information in PMC

References

    1. Centers for Disease Control and Prevention Diabetes Report Card 2017. 2018. https://www.cdc.gov/diabetes/pdfs/library/diabetesreportcard2017-508.pdf (Accessed 28 Feb 2020)
    1. Engelgau M.M., Geiss L.S., Saaddine J.B., Boyle J.P., Benjamin S.M., Gregg E.W., Tierney E.F., Rios-Burrows N., Mokdad A.H., Ford E.S., Imperatore G., Narayan K.M. The evolving diabetes burden in the United States. Ann. Intern. Med. 2004;140(11):945–950. - PubMed
    1. Alexopoulos A.S., Jackson G.L., Edelman D., Smith V.A., Berkowitz T.S.Z., Woolson S.L., Bosworth H.B., Crowley M.J. Clinical factors associated with persistently poor diabetes control in the Veterans Health Administration: a nationwide cohort study. PLoS One. 2019;14(3) - PMC - PubMed
    1. Crowley M.J., Holleman R., Klamerus M.L., Bosworth H.B., Edelman D., Heisler M. Factors associated with persistent poorly controlled diabetes mellitus: clues to improving management in patients with resistant poor control. Chronic Illn. 2014;10(4):291–302. - PMC - PubMed
    1. Gilmer T.P., O'Connor P.J., Rush W.A., Crain A.L., Whitebird R.R., Hanson A.M., Solberg L.I. Predictors of health care costs in adults with diabetes. Diabetes Care. 2005;28(1):59–64. - PubMed

Publication types

Substances