Table 3.
Schedule of Enrollment, Intervention and Assessments
| STUDY PERIOD | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
Eligibility Enrollment & Allocation |
Post-allocation | |||||||||
| Timepoint | Initial Screen |
Baseline/ Enrollment (Day 0) |
Inter-vention phase (Months 0–2) |
Weekly Follow-Up (Weeks 1–52) |
Follow-Up (Week 2) |
Monthly Follow-Up (Months 1–12) |
Follow-Up (Month 1) |
Follow-Up (Month 2) |
Follow-Up (Month 6) |
Follow-Up (Month 12) |
| Informed consent | x | x | ||||||||
| Demographics | x | x | ||||||||
| Medical history & medications | x | |||||||||
| Physical exam including objective outcomes | x | x | ||||||||
| Inclusion/Exclusion criteria | x | x | ||||||||
| Technology assessment** | x | |||||||||
| Intervention administered all 4 arms (booster sessions allowable in month 3–12) | x | |||||||||
| COVID − 19 impact | x | x | x | x | ||||||
| TUQ** | x | x | x | |||||||
| STarT Back screening tool status | x | x | x | x | ||||||
| Chronic LBP status (NIH research task force definition) | x | x | x | x | ||||||
| Chronic interference with daily activities | x | x | x | x | ||||||
| Low back pain intensity | x | x | x | |||||||
| Low back pain frequency | x | x | ||||||||
| Pain trajectory | x | x | ||||||||
| Implementation measures | x | x | x | x | x | |||||
| Allocation/Randomization | x | |||||||||
| Intervention uptake | x | x | x | |||||||
| Disability, PROMIS-29, healthcare and medication use, and productivity loss | x | x | ||||||||
| Adverse events* | x | x | x | |||||||
| Satisfaction and global improvement | x | x | x | |||||||
| Healing Encounters and Attitudes List (HEAL) non-specific factors | x | x | x | x | x | x | ||||
|
Psychosocial mediators (self-efficacy, coping, kinesiophobia, and pain catastrophizing) |
x | x | x | x | ||||||
| Participant close out | x | |||||||||
*Participants can also report adverse events to the PI’s or study staff at any point during the trial
** Technology Assessment and the Telehealth Usability Questionnaire (TUQ) will be administered to participants who are enrolled in the 2-arm study only. Tech Assessment may be administered to participants in the 4-arm study if applicable (e.g., preparing for a virtual SSM session)