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

2020 ◽  
Author(s):  
Stefan Elbers ◽  
Jan Pool ◽  
Harriët Wittink ◽  
Albère Köke ◽  
Else Scheffer ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Mobile Health ◽  
Treatment Program ◽  
Treatment Condition ◽  
Controlled Trial ◽  
Interdisciplinary Treatment ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Over Time

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. CLINICALTRIAL Netherlands Trial Register NL8076; https://www.trialregister.nl/trial/8076 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18632

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

10.2196/18632 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e18632
Author(s):  
Stefan Elbers ◽  
Jan Pool ◽  
Harriët Wittink ◽  
Albère Köke ◽  
Else Scheffer ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Mobile Health ◽  
Treatment Program ◽  
Treatment Condition ◽  
Controlled Trial ◽  
Interdisciplinary Treatment ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Over Time

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

scholarly journals RENaBack: low back pain patients in rehabilitation—study protocol for a multicenter, randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Laura Puerto Valencia ◽  
Diamantes Arampatzis ◽  
Heidrun Beck ◽  
Karsten Dreinhöfer ◽  
David Drießlein ◽  
...  
Keyword(s):  
Risk Factors ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Controlled Trial ◽  
Psychosocial Risk ◽  
Low Back ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Rehabilitation Aftercare

Abstract Background Millions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country. Methods The aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG). Discussion An improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers. Trial registration DRKS, DRKS00020373. Registered on 15 April 2020

scholarly journals Understanding the Effect of Adding Automated and Human Coaching to a Mobile Health Physical Activity App for Afghanistan and Iraq Veterans: Protocol for a Randomized Controlled Trial of the Stay Strong Intervention (Preprint)

2018 ◽  
Author(s):  
Lorraine R Buis ◽  
Felicia A McCant ◽  
Jennifer M Gierisch ◽  
Lori A Bastian ◽  
Eugene Z Oddone ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mobile Health ◽  
Controlled Trial ◽  
Health Coaching ◽  
Mobile App ◽  
Activity Monitoring ◽  
Smartphone App ◽  
Randomized Controlled ◽  
Over Time

BACKGROUND Although maintaining a healthy weight and physical conditioning are requirements of active military duty, many US veterans rapidly gain weight and lose conditioning when they separate from active-duty service. Mobile health (mHealth) interventions that incorporate wearables for activity monitoring have become common, but it is unclear how to optimize engagement over time. Personalized health coaching, either through tailored automated messaging or by individual health coaches, has the potential to increase the efficacy of mHealth programs. In an attempt to preserve conditioning and ward off weight gain, we developed Stay Strong, a mobile app that is tailored to veterans of recent conflicts and tracks physical activity monitored by Fitbit Charge 2 devices and weight measured on a Bluetooth-enabled scale. OBJECTIVE The goal of this study is to determine the effect of activity monitoring plus health coaching compared with activity monitoring alone. METHODS In this randomized controlled trial, with Stay Strong, a mobile app designed specifically for veterans, we plan to enroll 350 veterans to engage in an mHealth lifestyle intervention that combines the use of a wearable physical activity tracker and a Bluetooth-enabled weight scale. The Stay Strong app displays physical activity and weight data trends over time. Enrolled participants are randomized to receive the Stay Strong app (active comparator arm) or Stay Strong + Coaching, an enhanced version of the program that adds coaching features (automated tailored messaging with weekly physical activity goals and up to 3 telephone calls with a health coach—intervention arm) for 1 year. Our primary outcome is change in physical activity at 12 months, with weight, pain, patient activation, and depression serving as secondary outcome measures. All processes related to recruitment, eligibility screening, informed consent, Health Insurance Portability and Accountability Act authorization, baseline assessment, randomization, the bulk of intervention delivery, and outcome assessment will be accomplished via the internet or smartphone app. RESULTS The study recruitment began in September 2017, and data collection is expected to conclude in 2019. A total of 465 participants consented to participate and 357 (357/465, 77%) provided baseline levels of physical activity and were randomized to 1 of the 2 interventions. CONCLUSIONS This novel randomized controlled trial will provide much-needed findings about whether the addition of telephone-based human coaching and other automated supportive-coaching features will improve physical activity compared with using a smartphone app linked to a wearable device alone. CLINICALTRIAL ClinicalTrials.gov NCT02360293; https://clinicaltrials.gov/ct2/show/NCT02360293 (Archived by WebCite at http://www.webcitation.org/75KQeIFwh) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12526

Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

2020 ◽  
Vol 29 (1S) ◽  
pp. 412-424
Author(s):  
Elissa L. Conlon ◽  
Emily J. Braun ◽  
Edna M. Babbitt ◽  
Leora R. Cherney
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Treatment Fidelity ◽  
Protocol Adherence ◽  
Study Condition ◽  
Randomized Controlled ◽  
Aphasia Therapy ◽  
Percent Accuracy ◽  
Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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