Name/Construct | Type (i.e., primary, secondary, other) | Time Frame | Description / Instrument |
---|---|---|---|
Patient Health Questionnaire-8 (PHQ-8) [55] | Primary | Baseline and 6-month follow up | The PHQ-8 is an 8-item scale that screens for depression. Scores range from 0 to 24 with higher scores indicating greater severity of depression |
Generalized Anxiety Disorder Assessment (GAD-7) [54] | Primary | Baseline and 6-month follow up | The GAD-7 is a 7 item self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores range from 0 to 21, with higher scores indicating greater severity of anxiety |
Knee Injury and Osteoarthritis Outcome Score (KOOS) pain and function in daily living sub-scales [59] | Secondary | Baseline and 6-month follow up | The KOOS pain sub-scale is a 9-item scale that assesses knee pain. Scores range from 0 to 100 with lower scores indicating greater severity of pain. The KOOS function sub-scale is a 17-item scale that assesses function. Scores range from 0 to 100 with lower scores indicating worse knee function |
Lubben Social Network Scale-18 (LSNS-18) [56] | Secondary | Baseline and 6-month follow up | The LSNS-18 is an 18-item scale that measures perceived social support. Scores range from 0 to 90 with higher scores indicating greater social engagement |
12-Item Short Form Survey (SF-12) [57] | Secondary | Baseline and 6-month follow up | The SF-12 is a 12-item scale that assesses general health status. Scores range from 0 to 100 with higher scores indicating better physical and mental health functioning |
Pain Catastrophizing Scale (PCS) [58] | Secondary | Baseline and 6-month follow up | The PCS is a 13-item scale that assesses the level of catastrophic thinking related to an individual's pain. Scores range from 0 to 52 with higher scores indicating a higher level of pain-related anxiety |
General Self-Efficacy (GSE) [60] | Secondary | Baseline and 6-month follow up | General self-efficacy (GSE) is a reliable and valid instrument to assess this disposition. This scale is a self-report measure of self-efficacy of 10 items. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy |
Opioid use | Secondary | Baseline and 6-month follow up | Self-reported use of opioids for knee pain |
Patient-Reported Outcomes Information System (PROMIS) Sleep Disturbance Scale [61] | Secondary | Baseline and 6-month follow up | The PROMIS Sleep Disturbance Scale is a 8 item scale that measure self-reported perceptions of sleep quality, depth, and restoration within the past seven days. Scores range from with higher scores indicating greater sleep disturbances |
Surgical outcome | Secondary | 6-month follow up | Self-reported duration of inpatient rehabilitation |
Physical measurements | Secondary | Baseline and 6-month follow up | Physical measurements will be collected by a blinded researcher in-person and from the electronic health record: Knee range of motion using a goniometer, blood pressure, resting heart rate, weight, time up and go test, 6-min walk test, 30 s chair to stand test, and quadriceps strength using a handheld dynamometer |
Program Evaluation | Other | 6-month follow up or after dropping out from the study | All participants will complete a program evaluation survey at the end of their time with the study or at the time they drop out |
Demographics | Other | Baseline | Age, sex, race/ethnicity, education, insurance, income, work status, marital status |
Medical/Surgical history | Other | Baseline | Diagnosed conditions, medications/treatments, previous joint replacement surgeries |
Social history | Other | Baseline | Smoking, vaping, alcohol consumption history |
Implementation climate [46] | Feasibility | 6-month follow-up | We will determine the number of participants that completed the study in the attention control arm and Moving Well intervention arm and compare with how many initiate the study. The intervention will be considered feasible if more than 80% of enrolled participants complete the intervention and data collection points Retention of peer coaches in the study of 80% or more will be another metric that we will use for feasibility |
Implementation and Evaluation climate [46] | Reach | Baseline | We will collect demographic and social data on all the participants that join the intervention. We will store the demographic and social information of individuals that drop out from the study. This information will provide us with an understanding of how the intervention is reaching a diverse group of people with rheumatoid arthritis |
Implementation and Evaluation climate [46] | Adoption | At 6-month follow-up data collection or after dropping out from the study | We will collect demographic and social data among all participants. We will also be inviting both participants that completed the study and those that drop out, to participate in semi-structured interviews regarding their experience with the study, the Moving Well curriculum, and working with a peer coach. This information will allow us to improve the adoption of the intervention to a larger clinical trial |
Implementation and Evaluation climate [46] | Implementation/ Fidelity | Calls of sessions 1–12 between peer coaches/research staff and participants | All calls between peer coaches and participants will be recorded and reviewed by the research team to assess fidelity of the intervention Peer coaches must have discussed at least 80% of the items in the checklist of each of the sessions to make sure that the intervention is been delivered as intended. We will do additional training for peer coaches who are completing less than 80% of the corresponding session checklist |
Implementation and Evaluation climate [46] | Maintenance | Weekly throughout the study (weekly calls with peer coaches) and after 6-month follow up data collection | We will conduct semi-structured interviews to determine the best way to support participants and peer coaches, to maximize retention for the Moving Well program, and receive feedback for the intervention |