Trial Outcomes & Findings for Monitoring of Symptoms and Cognitive Function Using Telehealth (NCT NCT03184701)

NCT ID: NCT03184701

Last Updated: 2020-04-17

Results Overview

Number of Participants reporting Satisfaction with Device

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-04-17

Participant Flow

Participant milestones

Measure	Intervention Arm All study participants were included in this intervention arm, and given a device with questions to respond.
Overall Study STARTED	45
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Intervention Arm All study participants were included in this intervention arm, and given a device with questions to respond.
Overall Study Death	3
Overall Study Physician Decision	3
Overall Study Withdrawal by Subject	6
Overall Study Lost to Follow-up	5

Baseline Characteristics

Monitoring of Symptoms and Cognitive Function Using Telehealth

Baseline characteristics by cohort

Measure	Experimental n=45 Participants Patients assigned to this arm receive the intervention in addition to routine standard of care. Telehealth based remote monitoring of symptoms and brain tests is the intervention in this study. A device with preloaded questionaires will be given to patients randomized to this group. The patients will respond on a daily basis for the 3 months of intervention phase. Telehealth: Patients will be given an ipad with preloaded app (secured questions assessing their symptoms and cognitive function in a systematic timely way). The responses will be delivered to the care providers instantly, which will trigger an algorithmic clinical approach.
Age, Continuous	55.7 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: All participants who completed the end of study survey (at 3 months) are included.

Number of Participants reporting Satisfaction with Device

Outcome measures

Measure	Intervention Arm n=45 Participants All study participants were included in this intervention arm, and given a device with questions to respond.
Patient Satisfaction	45 Participants

POST_HOC outcome

Timeframe: 30 days

Number of admissions to the hospital

Outcome measures

Outcome data not reported

Adverse Events

Experimental

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manisha Verma

Albert Einstein Healthcare Netwrok

Phone: 2154561026

Email: vermam@einstein.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place