Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial

Stefan Elbers; Jan Pool; Harriët Wittink; Albère Köke; Else Scheffer; Rob Smeets

doi:10.2196/18632

Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial

Stefan Elbers^*, Jan Pool, Harriët Wittink, Albère Köke, Else Scheffer, Rob Smeets

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Article number	18632
Pages (from-to)	e18632
Number of pages	15
Journal	JMIR Research Protocols
Volume	9
Issue number	8
DOIs	https://doi.org/10.2196/18632
Publication status	Published - 18 Aug 2020

Keywords

telemedicine
chronic pain
recurrence
clinical trial protocol
rehabilitation
randomized controlled trial
cost-benefit analysis
treatment adherence and compliance
mobile apps
patient care team
SELF-EFFICACY QUESTIONNAIRE
PREFERENCE-BASED MEASURE
LOW-BACK-PAIN
FOLLOW-UP
REHABILITATION
ADHERENCE
DISABILITY
BEHAVIOR
IMPACT
SF-36

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10.2196/18632Licence: CC BY

Cite this

@article{f7639e557a7e45ebaec5863b84c23b9e,

title = "Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial",

abstract = "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.",

keywords = "telemedicine, chronic pain, recurrence, clinical trial protocol, rehabilitation, randomized controlled trial, cost-benefit analysis, treatment adherence and compliance, mobile apps, patient care team, SELF-EFFICACY QUESTIONNAIRE, PREFERENCE-BASED MEASURE, LOW-BACK-PAIN, FOLLOW-UP, REHABILITATION, ADHERENCE, DISABILITY, BEHAVIOR, IMPACT, SF-36",

author = "Stefan Elbers and Jan Pool and Harri{\"e}t Wittink and Alb{\`e}re K{\"o}ke and Else Scheffer and Rob Smeets",

note = "{\textcopyright}Stefan Elbers, Jan Pool, Harri{\"e}t Wittink, Alb{\`e}re K{\"o}ke, Else Scheffer, Rob Smeets. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.08.2020.",

year = "2020",

month = aug,

day = "18",

doi = "10.2196/18632",

language = "English",

volume = "9",

pages = "e18632",

journal = "JMIR Research Protocols",

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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 et al.
In: JMIR Research Protocols, Vol. 9, No. 8, 18632, 18.08.2020, p. e18632.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain

T2 - Protocol for a Randomized Controlled Trial

AU - Elbers, Stefan

AU - Pool, Jan

AU - Wittink, Harriët

AU - Köke, Albère

AU - Scheffer, Else

AU - Smeets, Rob

N1 - ©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.

PY - 2020/8/18

Y1 - 2020/8/18

N2 - 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.

AB - 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.

KW - telemedicine

KW - chronic pain

KW - recurrence

KW - clinical trial protocol

KW - rehabilitation

KW - randomized controlled trial

KW - cost-benefit analysis

KW - treatment adherence and compliance

KW - mobile apps

KW - patient care team

KW - SELF-EFFICACY QUESTIONNAIRE

KW - PREFERENCE-BASED MEASURE

KW - LOW-BACK-PAIN

KW - FOLLOW-UP

KW - REHABILITATION

KW - ADHERENCE

KW - DISABILITY

KW - BEHAVIOR

KW - IMPACT

KW - SF-36

U2 - 10.2196/18632

DO - 10.2196/18632

M3 - Article

C2 - 32808931

SN - 1929-0748

VL - 9

SP - e18632

JO - JMIR Research Protocols

JF - JMIR Research Protocols

IS - 8

M1 - 18632

ER -

Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial

Abstract

Keywords

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