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. 2020 Aug 18;9(8):e18632. doi: 10.2196/18632

Table 1.

Planned outcome domains, outcome measures, and statistical methods.

Outcome Hypothesis/research question Outcome measure Method of analysis
Primary



Self-perceived pain disability The development of pain disability over time after IMPTa will be more favorable for the enhanced treatment condition compared to usual care.

PDIb,c Multilevel analysis

Planned subgroup analysis on patients that scored 1 (“very much better”) or 2 (“much better”) on the GPEd scale at t1e. For patients that experienced meaningful treatment success, the development of pain disability over time after IMPT will be more favorable for the enhanced treatment condition compared to usual care. 1. PDIc
2. GPEf

Multilevel analysis
Secondary (quality of life)



Health care costs The enhanced treatment condition will be cost-effective compared with usual care at 3 and 6 months posttreatment. 1. SF-12f,g
2. iPCQf,h

Cost-effectiveness analysis

Illness perception The development of illness perceptions over time after IMPT will be more favorable for the enhanced treatment condition compared to usual care. IPQ-K DLVc,i Multilevel analysis

Pain self-efficacy The development of pain self-efficacy over time after IMPT will be more favorable for the enhanced treatment condition compared to usual care. PSEQc,j Multilevel analysis

Pain intensity The development of outcome measures over time may be affected by the level of pain intensity NRSc,k Multilevel analysis
Engagement and usability



Overall engagement The level of engagement and usability will be positively associated with a change in pain disability during follow up (t4lt1). 1. System usability scalef
2. System usage data of AGRIPPA app (see below)

Multiple linear regression

Frequency of engagement How does the frequency of engagement vary over time after treatment?

Average number of logins per week Descriptive statistics

Depth of engagement How does the average number of features accessed per login vary after treatment? Average number of features accessed per log-in Descriptive statistics

Duration of engagement How do the average minutes spent at each login as well as the total time spent with the app per week vary after treatment? 1. Average minutes spent at each login.
2. Total time spent with the app
Descriptive statistics

Active engagement with Insight Cards To what extent will the number of created Insight Cards increase or decrease after treatment? Number of Insight Cards created Descriptive statistics

Active engagement with VBGm To what extent will the number of created VBG cards increase or decrease after treatment? 1. Number of VBGs created.
2. Number of steps created
Descriptive statistics

aIMPT: interdisciplinary multimodal pain therapy.

bPDI: Pain Disability Index.

cOutcome measure is part of routine care.

dGPE: global perceived effect.

et1: immediately postintervention.

fOutcome measures will be obtained with an additional electronic survey.

gSF-12: 12-item short-form health survey.

hiPCQ: iMTA Productivity Cost Questionnaire.

iIPQ-K DLV: Dutch language version of the Illness Perception Questionnaire.

jPSEQ: Pain Self-Efficacy Questionnaire.

kNRS: numeric rating scale.

lt4: 12 months postintervention.

mVBG: Value-Based Goals.