Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial.
chronic pain
clinical trial protocol
cost-benefit analysis
mobile apps
patient care team
randomized controlled trial
recurrence
rehabilitation
telemedicine
treatment adherence and compliance
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
18 Aug 2020
18 Aug 2020
Historique:
received:
09
03
2020
accepted:
14
05
2020
revised:
30
04
2020
entrez:
19
8
2020
pubmed:
19
8
2020
medline:
19
8
2020
Statut:
epublish
Résumé
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. 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. 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. The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients. 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. Netherlands Trial Register NL8076; https://www.trialregister.nl/trial/8076. DERR1-10.2196/18632.
Sections du résumé
BACKGROUND
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
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
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
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
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
BACKGROUND
Netherlands Trial Register NL8076; https://www.trialregister.nl/trial/8076.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/18632.
Identifiants
pubmed: 32808931
pii: v9i8e18632
doi: 10.2196/18632
pmc: PMC7463414
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e18632Informations de copyright
©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.
Références
Scand J Pain. 2017 Oct;17:233-242
pubmed: 29229208
Pain. 2015 Jun;156(6):1003-7
pubmed: 25844555
Value Health. 2015 Sep;18(6):753-8
pubmed: 26409601
Eur J Pain. 2017 Mar;21(3):434-444
pubmed: 27634023
Am J Public Health. 2004 Mar;94(3):416-22
pubmed: 14998805
Br J Psychiatry. 2005 Aug;187:106-8
pubmed: 16055820
J Clin Epidemiol. 2010 Jul;63(7):760-766.e1
pubmed: 20056385
Appl Health Econ Health Policy. 2018 Dec;16(6):765-778
pubmed: 30094591
J Health Econ. 2002 Mar;21(2):271-92
pubmed: 11939242
Lancet. 2018 Jun 9;391(10137):2368-2383
pubmed: 29573872
Qual Life Res. 2010 Aug;19(6):853-64
pubmed: 20354795
Spine (Phila Pa 1976). 2012 Apr 15;37(8):711-5
pubmed: 21796022
PLoS One. 2017 Nov 9;12(11):e0187477
pubmed: 29121647
Int J Clin Pract. 2008 Jan;62(1):115-26
pubmed: 18039330
J Clin Epidemiol. 2013 Sep;66(9):1022-8
pubmed: 23790725
Ups J Med Sci. 2014 Aug;119(3):278-86
pubmed: 24878367
Cochrane Database Syst Rev. 2014 Sep 02;(9):CD000963
pubmed: 25180773
Pain. 2008 Feb;134(3):263-76
pubmed: 17498879
J Med Syst. 2015 Feb;39(2):1
pubmed: 25600193
Pain. 1991 Jan;44(1):5-28
pubmed: 2038489
Eur J Pain. 2006 May;10(4):287-333
pubmed: 16095934
Am J Lifestyle Med. 2013 Nov-Dec;7(6):395-404
pubmed: 27547170
Clin J Pain. 2011 Nov-Dec;27(9):811-8
pubmed: 21642845
Phys Ther. 2011 May;91(5):700-11
pubmed: 21451097
Lancet. 2012 Dec 15;380(9859):2163-96
pubmed: 23245607
Health Psychol Rev. 2016 Sep;10(3):277-96
pubmed: 26854092
J Clin Epidemiol. 1998 Nov;51(11):1055-68
pubmed: 9817123
Eur J Pain. 2016 Apr;20(4):541-51
pubmed: 26198386
Man Ther. 2012 Aug;17(4):330-5
pubmed: 22483222
Ann Fam Med. 2005 May-Jun;3 Suppl 1:S52-60
pubmed: 15928220
Can J Psychiatry. 2015 Apr;60(4):168-75
pubmed: 26174216
BMJ. 2014 Mar 07;348:g1687
pubmed: 24609605
J Psychosom Res. 2006 Jun;60(6):631-7
pubmed: 16731240
Am Psychol. 2014 Feb-Mar;69(2):119-30
pubmed: 24547798
Pain. 2008 Feb;134(3):239-40
pubmed: 18164134
Eur J Pain. 2007 Feb;11(2):153-63
pubmed: 16446108
Pain. 2013 Dec;154 Suppl 1:S101-7
pubmed: 23928026
J Med Internet Res. 2017 Dec 06;19(12):e402
pubmed: 29212630
PM R. 2012 May;4(5):355-66
pubmed: 22342820
Pain. 2013 Oct;154(10):1929-31
pubmed: 23742793
Behav Res Ther. 2016 Nov;86:23-34
pubmed: 27614948
J Cardiopulm Rehabil Prev. 2012 Mar-Apr;32(2):63-70
pubmed: 22193934
Rehabil Psychol. 2013 Nov;58(4):323-33
pubmed: 24041250
J Med Internet Res. 2017 Aug 24;19(8):e295
pubmed: 28838887
Ann Rheum Dis. 2004 Jun;63(6):723-9
pubmed: 15140781
J Med Internet Res. 2018 Jun 08;20(6):e201
pubmed: 29884608
Clin J Pain. 2009 Jun;25(5):356-64
pubmed: 19454868
Med Care. 2004 Sep;42(9):851-9
pubmed: 15319610
JMIR Mhealth Uhealth. 2019 Jan 18;7(1):e11941
pubmed: 30664463
Int J Technol Assess Health Care. 2018 Jan;34(4):400-409
pubmed: 30047357
Transl Behav Med. 2020 Feb 3;10(1):267-277
pubmed: 30927357
Man Ther. 2015 Feb;20(1):10-7
pubmed: 25435470
Musculoskeletal Care. 2017 Mar;15(1):59-68
pubmed: 27098842
NPJ Digit Med. 2018 May 9;1:12
pubmed: 31304297
Percept Mot Skills. 1984 Dec;59(3):974
pubmed: 6240632
Spine (Phila Pa 1976). 2003 Aug 1;28(15):1739-45
pubmed: 12897502
Int J Clin Pract. 2015 Jan;69(1):9-32
pubmed: 25472682