Cargando…
Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial
BACKGROUND: To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies. OBJECTIVE: The aims of this project are (1) to test the effectiveness of the A...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7463414/ https://www.ncbi.nlm.nih.gov/pubmed/32808931 http://dx.doi.org/10.2196/18632 |
_version_ | 1783577126637666304 |
---|---|
author | Elbers, Stefan Pool, Jan Wittink, Harriët Köke, Albère Scheffer, Else Smeets, Rob |
author_facet | Elbers, Stefan Pool, Jan Wittink, Harriët Köke, Albère Scheffer, Else Smeets, Rob |
author_sort | Elbers, Stefan |
collection | PubMed |
description | BACKGROUND: To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies. OBJECTIVE: The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users. METHODS: We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses. RESULTS: The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients. CONCLUSIONS: This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice. TRIAL REGISTRATION: Netherlands Trial Register NL8076; https://www.trialregister.nl/trial/8076 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18632 |
format | Online Article Text |
id | pubmed-7463414 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-74634142020-09-17 Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial Elbers, Stefan Pool, Jan Wittink, Harriët Köke, Albère Scheffer, Else Smeets, Rob JMIR Res Protoc Protocol BACKGROUND: To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies. OBJECTIVE: The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users. METHODS: We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses. RESULTS: The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients. CONCLUSIONS: This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice. TRIAL REGISTRATION: Netherlands Trial Register NL8076; https://www.trialregister.nl/trial/8076 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18632 JMIR Publications 2020-08-18 /pmc/articles/PMC7463414/ /pubmed/32808931 http://dx.doi.org/10.2196/18632 Text en ©Stefan Elbers, Jan Pool, Harriët Wittink, Albère Köke, Else Scheffer, Rob Smeets. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.08.2020. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included. |
spellingShingle | Protocol Elbers, Stefan Pool, Jan Wittink, Harriët Köke, Albère Scheffer, Else Smeets, Rob Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial |
title | Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial |
title_full | Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial |
title_fullStr | Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial |
title_full_unstemmed | Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial |
title_short | Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial |
title_sort | mobile health app (agrippa) to prevent relapse after successful interdisciplinary treatment for patients with chronic pain: protocol for a randomized controlled trial |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7463414/ https://www.ncbi.nlm.nih.gov/pubmed/32808931 http://dx.doi.org/10.2196/18632 |
work_keys_str_mv | AT elbersstefan mobilehealthappagrippatopreventrelapseaftersuccessfulinterdisciplinarytreatmentforpatientswithchronicpainprotocolforarandomizedcontrolledtrial AT pooljan mobilehealthappagrippatopreventrelapseaftersuccessfulinterdisciplinarytreatmentforpatientswithchronicpainprotocolforarandomizedcontrolledtrial AT wittinkharriet mobilehealthappagrippatopreventrelapseaftersuccessfulinterdisciplinarytreatmentforpatientswithchronicpainprotocolforarandomizedcontrolledtrial AT kokealbere mobilehealthappagrippatopreventrelapseaftersuccessfulinterdisciplinarytreatmentforpatientswithchronicpainprotocolforarandomizedcontrolledtrial AT schefferelse mobilehealthappagrippatopreventrelapseaftersuccessfulinterdisciplinarytreatmentforpatientswithchronicpainprotocolforarandomizedcontrolledtrial AT smeetsrob mobilehealthappagrippatopreventrelapseaftersuccessfulinterdisciplinarytreatmentforpatientswithchronicpainprotocolforarandomizedcontrolledtrial |