Table 2.
LHR training in the CALMS-D and DREAM studies
| Study | Hours | Topics | Training materials | Training methods |
|---|---|---|---|---|
| Human subjects protection | ||||
| CALMS-D DREAM | 3 | What is research, research ethics, principles of human subject protection, the role of the institutional review board, and informed consent | Harvard Catalyst | Presentation, discussion, case studies |
| CALMS-D DREAM | 2 | Privacy, confidentiality, and data protection practices | Harvard Catalyst | Presentation, discussion, case studies |
| CALMS-D DREAM | 3 | Documenting informed consent, authorization of HIPAA, and permission for release of information | Harvard Catalyst | Presentation, discussion, case studies |
| Research methods | ||||
| CALMS-D DREAM | 2 | Protocol, standardization, recruitment, screening | Study manual | Presentation, discussion |
| CALMS-D DREAM | 2 | Study design, randomization, personnel roles, supervision, meetings, documentation, emergency procedures | Study manual | Presentation, discussion |
| Data Collection – Biological | ||||
| CALMS-D DREAM | 3 | Anthropometrics, BP | Scale, stadiometer, blood pressure cuff | Demonstration, practice, online tutorial |
| CALMS-D | 3 | Experimental physical challenges (sit-to-stand, handgrip) | Dynamometer, BP cuff | Demonstration, practice |
| CALMS-D | 1 | Urine sample | Sample container, cooler | Demonstration, discussion |
| DREAM | 2 | Facilitating fasting blood samples at local laboratory | Online laboratory scheduler | Demonstration, discussion |
| DREAM | 1 | Hair sample | Scissors, razor, string, foil | Demonstration, practice, online tutorial |
| Data Collection – behavioral | ||||
| DREAM | 1 | Instrumenting with actigraphy | Actigraphy devices | Demonstration, practice |
| Data Collection – Survey | ||||
| CALMS-D DREAM | 1 | Standardization, establishing rapport, reading questions, voice personality, being non-judgmental, probing techniques, minimizing disturbances during home visits | Study manual | Presentation, observation, live practice |
| CALMS-D DREAM | 1 | Responding to participant distress, seeking supervision for participant suicidality, pacing, and knowing when to take a break, reschedule, or discontinue an interview | Study manual | Presentation, observation, live practice |
| CALMS-D | 3 | Training participants to use the interactive voice response system. | Study manual; IVR survey; headphones; cell phones | Demonstration, practice, |
| Data Entry | ||||
| CALMS-D DREAM | 2 | Remote Electronic Data Capture (REDCap) | Tablet, paper forms | Presentation, discussion, live practice |
| Sample Handling and Data Transfer | ||||
| CALMS-D DREAM | 1 | Coding, mailing, and tracking devices and samples | Study manual | Presentation, discussion |
| CALMS-D DREAM | 1 | Cleaning equipment, re-ordering supplies | Handout | Discussion |
| Participant Safety | ||||
| CALMS-D DREAM | 1 | Protocols for out of range values (e.g., very high BP) | Study manual | Presentation, discussion |
| CALMS-D DREAM | 2 | Protocols for potential participant suicidality/self-harm | Handout | Presentation, discussion |
| LHR Safety | ||||
| CALMS-D DREAM | 1 | Home visits, trust your gut, working in pairs, parking, protecting study equipment, emergency procedures | Study manual | Presentation, discussion |
| CALMS-D | 2 | Blood-borne pathogens | University online tutorial | Video, quiz |