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.
ABSTRACT
BACKGROUND: The mSEBT is a screening tool used to evaluate dynamic balance. Most research investigating measurement properties focused on intrarater reliability and was done in small samples. To know whether the mSEBT is useful to discriminate dynamic balance between persons and to evaluate changes in dynamic balance, more research into intra- and interrater reliability and smallest detectable change (synonymous with minimal detectable change) is needed. PURPOSE: To estimate intra- and interrater reliability and smallest detectable change of the mSEBT in adults at risk for ankle sprain. STUDY DESIGN: Cross-sectional, test-retest design. METHODS: Fifty-five healthy young adults participating in sports at risk for ankle sprain participated (mean ± SD age, 24.0 ± 2.9 years). Each participant performed three test sessions within one hour and was rated by two physical therapists (session 1, rater 1; session 2, rater 2; session 3, rater 1). Participants and raters were blinded for previous measurements. Normalized composite and reach direction scores for the right and left leg were collected. Analysis of variance was used to calculate intraclass correlation coefficient values for intra- and interrater reliability. Smallest detectable change values were calculated based on the standard error of measurement. RESULTS: Intra- and interrater reliability for both legs was good to excellent (intraclass correlation coefficient ranging from 0.87 to 0.94). The intrarater smallest detectable change for the composite score of the right leg was 7.2% and for the left 6.2%. The interrater smallest detectable change for the composite score of the right leg was 6.9% and for the left 5.0%. CONCLUSION: The mSEBT is a reliable measurement instrument to discriminate dynamic balance between persons. Most smallest detectable change values of the mSEBT appear to be large. More research is needed to investigate if the mSEBT is usable for evaluative purposes. LEVEL OF EVIDENCE: Level 2.
