. 2021 Aug 25;3:714813. doi: 10.3389/fdgth.2021.714813

Table 3.

Assessment schedule.

	Screening period		Baseline period			Intervention period (weeks 1–48)		Follow up period
Time point name	Telephone pre-screening	Screening	Baseline	Baseline MRI	Tech install	Month 6	Month 6 MRI	Month 12	Tech uninstall	Telephone follow up
Approximate time required	30 min.	4 h	3 h	2 h	1–2 h	4 h	2 h	4 h	30 min.	30 min.
Scheduling Timeframe		10-week window				Week 25–26	Week 25–26	Week 49–50	Week 49–50	Week 52
Collect informed consent		X
Pre-visit stability screening^v		X	X			X		X
Collect PCP/contact information^b		X
Demographics (NACC form A1)		X
Social isolation assessment	X	X				X^x		X^x		X
GDS (NACC form B6)^t		X				X		X		X
Neuropsychological battery (NACC form C2)^u		X				X		X
CDR (NACC form B4)		X				X		X
Subject health history (NACC form A5)		X
Medication assessment		X				X		X
MRI safety/eligibility screening^a		X		X			X
Subject compensation		X^{c, w}		X		X^d	X	X^d
Collect NEO-FFI^e		→	X^e			X^f		X^f
Clinician diagnosis^s		X				X		X
Trial eligibility assessment^h	X	X
Post-study resources		X^g						X		X
Randomization		Xⁱ
NIH toolbox			X			X		X
OTDL-R			X			X		X
Family history of dementia			X
Physical evaluation (NACC form B1)			X			X^j		X^j
Saliva collection for APOE ε4			X°
MRI^q				X			X
Vitamin C pillbox^l					X				X
Video chat device^m					X				X
PANAS^{k, m}						X
Video chat intervention^m						X (4 times per week for 6 months, 2 times per week for additional 6 months)
I-CONECT weekly questionnaireⁿ						X
Medication adherence (vitamin C)^l						X^p
Qualitative evaluation (subject)^m						X^r		X^r

NACC, National Alzheimer's Coordinating Center; X, Collected.

At participating sites, subject medical records may be requested if more information is needed to make MRI eligibility determination; final determination may occur any time prior to Baseline MRI.

Subjects may choose to provide emergency contact and primary care provider contact information; this is optional.

Compensation will be provided to all subjects who consent to participate, including screen failures.

Compensation to be provided once all procedures are completed.

The NEO-FFI will be left for subjects to complete independently at the end of the last Screening visit. The questionnaire will be collected and reviewed at the Baseline visit. If the subject did not successfully complete the questionnaire on his or her own, the questionnaire will be completed during the Baseline visit.

If multiple visits will be done to complete all assessments, the questionnaire may be provided at one visit and collected at the subsequent visit. If only one visit is planned for all assessments, the questionnaire may be provided ahead of the visit for collection at the visit.

Resources to be provided at this time point only if subject is a screen failure.

Final eligibility assessment to be completed upon clinician diagnosis.

ⁱ

Randomization to intervention/control occurs once eligibility is determined, prior to the Baseline visit. Subjects should not be notified of group assignment until after Baseline to prevent them from unblinding the assessment staff.

Only blood pressure will be collected at Month 6 and Month 12.

The PANAS will be administered at the beginning and the end of the subject's first video chat session each week.

OHSU subjects only.

Intervention group only. Control group does not receive.

ⁿ

Administered weekly via telephone.

This procedure is optional for subjects. If sample cannot be obtained, collection will be re-attempted at a future visit.

Occurs daily. If the subject misses the target time but remembers the same day, the subject should take the vitamin as soon as they remember. If the subject does not remember until the next day or later, the subject should skip the missed dose and leave the vitamin in the pillbox.

To be completed for subjects who have been assigned to receive MRIs, at participating sites only.

To be completed at the conclusion of the Week 26 and Week 48 video chats. Administration and responses will be audio and video recorded.

The clinician diagnosis must be completed within 1 week once the time point assessments have been completed. Subjects who are diagnosed with dementia must be withdrawn from the trial immediately.

If subject scores 2 or more in response to questions 3, 7, 11,12, or 14 (the suicide ideation subscale), the Depression Safety Assessment will be conducted.

Administration will be audio recorded. Battery assessments must be completed in the order presented in the administration packet to ensure appropriate timing for memory assessments.

If time point assessments are split into multiple visits, this form should be administered at each in-person visit.

Subjects will not receive additional compensation for rescreening.