Trial Outcomes & Findings for Telemedicine Intervention to Improve Cognitive Function (NCT NCT02248649)

Results Overview

The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

160 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2019-07-24

Participant Flow

Participant milestones

Participant milestones
Measure	Physical Activity Structured walking program Structured physical activity: Walking instruction and encouragement	Control Health education attention control Health education: Provision of general information about a variety of health topics Provision of general information about a variety of health
Overall Study STARTED	80	80
Overall Study COMPLETED	59	59
Overall Study NOT COMPLETED	21	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Physical Activity Structured walking program Structured physical activity: Walking instruction and encouragement	Control Health education attention control Health education: Provision of general information about a variety of health topics Provision of general information about a variety of health
Overall Study Death	7	11
Overall Study Lost to Follow-up	14	10

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physical Activity n=80 Participants Structured walking program Structured physical activity: Walking instruction and encouragement	Control n=80 Participants Health education attention control Health education: Provision of general information about a variety of health topics Provision of general information about a variety of health	Total n=160 Participants Total of all reporting groups
Age, Continuous	74.8 years STANDARD_DEVIATION 8.6 • n=80 Participants	74.6 years STANDARD_DEVIATION 8.3 • n=80 Participants	74.7 years STANDARD_DEVIATION 8.4 • n=160 Participants
Sex: Female, Male Female	2 Participants n=80 Participants	0 Participants n=80 Participants	2 Participants n=160 Participants
Sex: Female, Male Male	78 Participants n=80 Participants	80 Participants n=80 Participants	158 Participants n=160 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	80 Participants n=80 Participants	80 Participants n=80 Participants	160 Participants n=160 Participants
Years of education	13.6 years STANDARD_DEVIATION 2.8 • n=80 Participants	14.1 years STANDARD_DEVIATION 2.5 • n=80 Participants	13.8 years STANDARD_DEVIATION 2.7 • n=160 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: number of participants analyzed: participants with ADAS-Cog scores at baseline and at 6 months. 4 participants in Physical Activity group and 6 participants in Control group did not have a score at 6 months.

The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.

Outcome measures

Outcome measures
Measure	Physical Activity n=76 Participants Structured walking program Structured physical activity: Walking instruction and encouragement	Control n=74 Participants Health education attention control Health education: Provision of general information about a variety of health topics Provision of general information about a variety of health
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6	-0.24 score on a scale Standard Error 0.62	0.95 score on a scale Standard Error 0.78

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: number of participants analyzed: participants with ADAS-Cog scores at baseline and at 12 months. 17 participants in Physical Activity group and 15 participants in Control group did not have a score at 12 months.

The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.

Outcome measures

Outcome measures
Measure	Physical Activity n=63 Participants Structured walking program Structured physical activity: Walking instruction and encouragement	Control n=65 Participants Health education attention control Health education: Provision of general information about a variety of health topics Provision of general information about a variety of health
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12	0.12 units on a scale Standard Error 0.79	2.60 units on a scale Standard Error 0.91

SECONDARY outcome

Timeframe: Baseline and 18 month

Population: number of participants analyzed: participants with ADAS-Cog scores at baseline and at 18 months. 21 participants in Physical Activity group and 21 participants in Control group did not have a score at 18 months.

The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.

Outcome measures

Outcome measures
Measure	Physical Activity n=59 Participants Structured walking program Structured physical activity: Walking instruction and encouragement	Control n=59 Participants Health education attention control Health education: Provision of general information about a variety of health topics Provision of general information about a variety of health
Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18	0.40 units on a scale Standard Error 0.99	3.60 units on a scale Standard Error 1.03

Adverse Events

Physical Activity

Serious events: 7 serious events

Other events: 0 other events

Deaths: 7 deaths

Control

Serious events: 11 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Physical Activity n=80 participants at risk Structured walking program Structured physical activity: Walking instruction and encouragement	Control n=80 participants at risk Health education attention control Health education: Provision of general information about a variety of health topics Provision of general information about a variety of health
General disorders Death	8.8% 7/80 • Number of events 7 • 18 months	13.8% 11/80 • Number of events 11 • 18 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Sparrow

VA Boston Healthcare System

Phone: 857-364-6407

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place