Table 2.
Feasibility, acceptability, and efficacy data to be collected.
| Factor/Outcome | Information Gathered | Data Source/Measure | |
|---|---|---|---|
| Feasibility & Acceptability | |||
| Process | Recruitment | % (of # approached) recruited over 1 mo; % recruited from various sources | Recruitment logs; Screening forms |
| Reach | Representativeness of individuals willing and eligible to participate | Recruitment logs; Screening forms; Antelope Valley census data; AVCC patient statistics | |
| Retention | % completing post-intervention assessment | Testing logs | |
| Adherence | 16-wk session-by-session attendance | Intervener attendance logs | |
| Fidelity | Proportion of applicable core intervention elements incorporated; Perceived use of core intervention elements | Fidelity index; Stakeholder interviews; Intervener session notes | |
| Implementation barriers/facilitators | Perceived implementation barriers/facilitators | Participant focus groups; Participant interviews; Stakeholder interviews | |
| Implementation alterations | Changes made to the intervention during implementation | Intervener session notes; Stakeholder interviews; Study team daily operations communications | |
| Satisfaction | Participant and stakeholder experiences | Participant interview and survey; Participant focus groups; Stakeholder interviews | |
| Adoption | Willingness by staff and primary care provider to initiate the program | Stakeholder interviews | |
| Resources | Equipment reliability | Equipment availability and functionality | Stakeholder interviews; Study team daily operations communications; Staff time logs; Expenditures log |
| Personnel | Sufficiency of personnel to carry out all aspects of the study | ||
| Space | Sufficiency of space to carry out study | ||
| Time | Sufficiency of time to carry out study | ||
| Budget | Study expenditures | ||
| Management | Data | Database set-up; Data accessibility, accuracy and maintenance; EMR availability | REDCap; Stakeholder interviews; Study team daily operations communications; EMRs |
| Administration | Research team’s administrative capacity to manage the study; Compliance with human subjects protection protocol | Stakeholder interviews; Study team daily operations communications; Intervener notes; Adverse event logs | |
| Preliminary Efficacy | |||
| Scientific Assessment | Safety | # and type of adverse events documented | Adverse event logs |
| Patient-identified symptom profile (PISP) | Change in symptom impact/severity | MYMOP2 | |
| Food frequency | Change in dietary intake | Block FFQ | |
| Physical activity | Change in physical activity level | IPAQ | |
| Social functioning satisfaction | Change in satisfaction with social participation | PROMIS Short Form 7a: Satisfaction with Social Roles; Satisfaction with Participation in Discretionary Social Activities | |
| Sleep quality | Change in quality of sleep | PSQI | |
| Stress | Change in perceived stress level | Single Item Stress Index | |
| Hemoglobin A1c | Change in hemoglobin A1c | Non-fasting hemoglobin A1c test via finger prick | |
| Blood pressure | Change in systolic/diastolic blood pressure | Digital blood pressure reading | |
| BMI (kg/m) | Change in BMI | Digital scale and stadiometer reading | |
| Waist/hip circumference | Change in waist and hip circumference | Tape measure | |
| Coronary heart disease risk | Change in coronary heart disease risk | Framingham Risk Score LDL Points Total | |
| Diabetes risk | Change in risk for diabetes | EPIC Diabetes Risk Score | |
| Patient activation | Activation level (baseline not available) | PAM 13 | |
AVCC= Antelope Valley Community Clinic; Block FFQ= Block 2005 Food Frequency Questionnaire Spanish Version; BMI= body mass index; EPIC= European Prospective Investigation into Cancer and Nutrition; EMR= electronic medical record; IPAQ = International Physical Activity Questionnaire; MYMOP2= Measure Yourself Medical Outcome Profile; PAM 13= Patient Activation Measure 13-item short form; PROMIS= Patient Reported Outcomes Measurement Information System; PSQI= Pittsburgh Sleep Quality Index; SES= socioeconomic status; SRT= signed rank test.