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Protocol for the pilot randomized trial of the CArdiovascular Risk assEssment for Rheumatoid Arthritis (CARE RA) intervention: a peer coach behavioral intervention

BACKGROUND: Cardiovascular disease (CVD) is the most common cause of death among people with rheumatoid arthritis (RA), with an estimated increased risk of 50–60% compared to the general population. Lipid-lowering strategies have been shown to lower CVD risk significantly in people with RA and hyper...

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Autores principales: Weiner, Joan, Lui, Geyanne, Brown, Mackenzie, Páez, Yuliana Domínguez, Fritz, Shelley, Sydnor-Campbell, Tien, Allen, Aberdeen, Jabri, Assem, Venkatachalam, Shilpa, Gavigan, Kelly, Nowell, William Benjamin, Curtis, Jeffrey R., Fraenkel, Liana, Safford, Monika, Navarro-Millán, Iris
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9011938/
https://www.ncbi.nlm.nih.gov/pubmed/35428359
http://dx.doi.org/10.1186/s40814-022-01041-z
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author Weiner, Joan
Lui, Geyanne
Brown, Mackenzie
Páez, Yuliana Domínguez
Fritz, Shelley
Sydnor-Campbell, Tien
Allen, Aberdeen
Jabri, Assem
Venkatachalam, Shilpa
Gavigan, Kelly
Nowell, William Benjamin
Curtis, Jeffrey R.
Fraenkel, Liana
Safford, Monika
Navarro-Millán, Iris
author_facet Weiner, Joan
Lui, Geyanne
Brown, Mackenzie
Páez, Yuliana Domínguez
Fritz, Shelley
Sydnor-Campbell, Tien
Allen, Aberdeen
Jabri, Assem
Venkatachalam, Shilpa
Gavigan, Kelly
Nowell, William Benjamin
Curtis, Jeffrey R.
Fraenkel, Liana
Safford, Monika
Navarro-Millán, Iris
author_sort Weiner, Joan
collection PubMed
description BACKGROUND: Cardiovascular disease (CVD) is the most common cause of death among people with rheumatoid arthritis (RA), with an estimated increased risk of 50–60% compared to the general population. Lipid-lowering strategies have been shown to lower CVD risk significantly in people with RA and hyperlipidemia. Thus, CVD risk assessment has an important role to play in reducing CVD among people with RA. Yet currently only 37 to 45% of this population are receiving primary lipids screening. This paper describes the CArdiovascular Risk assEssment for RA (CARE RA) intervention, which is designed to address this issue. CARE RA is a peer coach intervention, that is, an intervention in which a person with RA coaches another person with RA, which is designed to educate people with RA about the relation between RA and CVD risk and to help them obtain evidence-based CVD risk assessment and treatment. METHODS: This is an open-label pilot study that will test if the participants assigned to complete the CARE RA curriculum with a peer coach will receive a cardiovascular risk assessment more frequently compared to those that complete the CARE RA curriculum by themselves. The CARE RA intervention is guided by Social Cognitive Theory. Participants in the peer coach intervention arm will receive the assistance of a peer coach who will call the participants once a week for 5 weeks to go over the CARE RA curriculum and train them on how to obtain CVD risk assessment. The control arm will complete the CARE RA curriculum without any assistance. Participants will be randomized 1:1 either to the control arm or to the peer coach intervention arm. The primary outcome is a participant’s having a CVD risk assessment or initiating a statin, if indicated. Secondary outcomes include patient activation and RA medication adherence. The RE-AIM implementation framework guides the implementation and evaluation of the intervention. DISCUSSION: This pilot study will test the feasibility of the peer coach intervention in anticipation of a larger trial. CARE RA pioneers the use of peer coaches to facilitate the implementation of evidence-based treatment guidelines among people with RA. TRIAL REGISTRATION: ClinicalTrials.gov NCT04488497. Registered on July 28, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01041-z.
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spelling pubmed-90119382022-04-16 Protocol for the pilot randomized trial of the CArdiovascular Risk assEssment for Rheumatoid Arthritis (CARE RA) intervention: a peer coach behavioral intervention Weiner, Joan Lui, Geyanne Brown, Mackenzie Páez, Yuliana Domínguez Fritz, Shelley Sydnor-Campbell, Tien Allen, Aberdeen Jabri, Assem Venkatachalam, Shilpa Gavigan, Kelly Nowell, William Benjamin Curtis, Jeffrey R. Fraenkel, Liana Safford, Monika Navarro-Millán, Iris Pilot Feasibility Stud Study Protocol BACKGROUND: Cardiovascular disease (CVD) is the most common cause of death among people with rheumatoid arthritis (RA), with an estimated increased risk of 50–60% compared to the general population. Lipid-lowering strategies have been shown to lower CVD risk significantly in people with RA and hyperlipidemia. Thus, CVD risk assessment has an important role to play in reducing CVD among people with RA. Yet currently only 37 to 45% of this population are receiving primary lipids screening. This paper describes the CArdiovascular Risk assEssment for RA (CARE RA) intervention, which is designed to address this issue. CARE RA is a peer coach intervention, that is, an intervention in which a person with RA coaches another person with RA, which is designed to educate people with RA about the relation between RA and CVD risk and to help them obtain evidence-based CVD risk assessment and treatment. METHODS: This is an open-label pilot study that will test if the participants assigned to complete the CARE RA curriculum with a peer coach will receive a cardiovascular risk assessment more frequently compared to those that complete the CARE RA curriculum by themselves. The CARE RA intervention is guided by Social Cognitive Theory. Participants in the peer coach intervention arm will receive the assistance of a peer coach who will call the participants once a week for 5 weeks to go over the CARE RA curriculum and train them on how to obtain CVD risk assessment. The control arm will complete the CARE RA curriculum without any assistance. Participants will be randomized 1:1 either to the control arm or to the peer coach intervention arm. The primary outcome is a participant’s having a CVD risk assessment or initiating a statin, if indicated. Secondary outcomes include patient activation and RA medication adherence. The RE-AIM implementation framework guides the implementation and evaluation of the intervention. DISCUSSION: This pilot study will test the feasibility of the peer coach intervention in anticipation of a larger trial. CARE RA pioneers the use of peer coaches to facilitate the implementation of evidence-based treatment guidelines among people with RA. TRIAL REGISTRATION: ClinicalTrials.gov NCT04488497. Registered on July 28, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40814-022-01041-z. BioMed Central 2022-04-15 /pmc/articles/PMC9011938/ /pubmed/35428359 http://dx.doi.org/10.1186/s40814-022-01041-z Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Weiner, Joan
Lui, Geyanne
Brown, Mackenzie
Páez, Yuliana Domínguez
Fritz, Shelley
Sydnor-Campbell, Tien
Allen, Aberdeen
Jabri, Assem
Venkatachalam, Shilpa
Gavigan, Kelly
Nowell, William Benjamin
Curtis, Jeffrey R.
Fraenkel, Liana
Safford, Monika
Navarro-Millán, Iris
Protocol for the pilot randomized trial of the CArdiovascular Risk assEssment for Rheumatoid Arthritis (CARE RA) intervention: a peer coach behavioral intervention
title Protocol for the pilot randomized trial of the CArdiovascular Risk assEssment for Rheumatoid Arthritis (CARE RA) intervention: a peer coach behavioral intervention
title_full Protocol for the pilot randomized trial of the CArdiovascular Risk assEssment for Rheumatoid Arthritis (CARE RA) intervention: a peer coach behavioral intervention
title_fullStr Protocol for the pilot randomized trial of the CArdiovascular Risk assEssment for Rheumatoid Arthritis (CARE RA) intervention: a peer coach behavioral intervention
title_full_unstemmed Protocol for the pilot randomized trial of the CArdiovascular Risk assEssment for Rheumatoid Arthritis (CARE RA) intervention: a peer coach behavioral intervention
title_short Protocol for the pilot randomized trial of the CArdiovascular Risk assEssment for Rheumatoid Arthritis (CARE RA) intervention: a peer coach behavioral intervention
title_sort protocol for the pilot randomized trial of the cardiovascular risk assessment for rheumatoid arthritis (care ra) intervention: a peer coach behavioral intervention
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9011938/
https://www.ncbi.nlm.nih.gov/pubmed/35428359
http://dx.doi.org/10.1186/s40814-022-01041-z
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