Trial Outcomes & Findings for Improving Adherence to Cognitive Rehabilitation (NCT NCT02481713)

NCT ID: NCT02481713

Last Updated: 2021-11-04

Results Overview

number of cognitive training sessions attended

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 114 participants
• Primary outcome timeframe: end of four month training period
• Results posted on: 2021-11-04

Participant Flow

Participant milestones

Measure	MI Condition motivational interview condition motivational interviewing: motivational interviewing	CI Condition learning style interview condition learning style interviews: interview and feedback about learning style
Overall Study STARTED	56	58
Overall Study COMPLETED	40	42
Overall Study NOT COMPLETED	16	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Adherence to Cognitive Rehabilitation

Baseline characteristics by cohort

Measure	MI Condition n=56 Participants motivational interview condition motivational interviewing: motivational interviewing	CI Condition n=58 Participants learning style interview condition learning style interviews: interview and feedback about learning style	Total n=114 Participants Total of all reporting groups
Age, Continuous	56.52 years STANDARD_DEVIATION 10.40 • n=5 Participants	53.34 years STANDARD_DEVIATION 12.74 • n=7 Participants	55.41 years STANDARD_DEVIATION 11.65 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	48 Participants n=7 Participants	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Education	12.52 years STANDARD_DEVIATION 2.42 • n=5 Participants	13.04 years STANDARD_DEVIATION 2.21 • n=7 Participants	12.79 years STANDARD_DEVIATION 2.32 • n=5 Participants
Marital status ever married	31 Participants n=5 Participants	29 Participants n=7 Participants	60 Participants n=5 Participants
Marital status never married	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Number of hospitalizations	4.0 hospitalizations n=5 Participants	4.0 hospitalizations n=7 Participants	4.0 hospitalizations n=5 Participants

PRIMARY outcome

Timeframe: end of four month training period

number of cognitive training sessions attended

Outcome measures

Measure	MI Condition n=56 Participants motivational interview condition motivational interviewing: motivational interviewing	CI Condition n=58 Participants learning style interview condition learning style interviews: interview and feedback about learning style
Number of Sessions Attended	7.70 sessions Standard Deviation 10.82	4.98 sessions Standard Deviation 6.63

PRIMARY outcome

Timeframe: end of 4 month training period

Population: participants who attended at least 1 cognitive training session

number of sessions attended among patients who attended at least 1 session

Outcome measures

Measure	MI Condition n=41 Participants motivational interview condition motivational interviewing: motivational interviewing	CI Condition n=40 Participants learning style interview condition learning style interviews: interview and feedback about learning style
Number of Sessions Attended	10.51 sessions Standard Deviation 11.43	7.23 sessions Standard Deviation 6.91

Adverse Events

MI Condition

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

CI Condition

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	MI Condition n=56 participants at risk motivational interview condition motivational interviewing: motivational interviewing	CI Condition n=58 participants at risk learning style interview condition learning style interviews: interview and feedback about learning style
Respiratory, thoracic and mediastinal disorders admit/chest pain	1.8% 1/56 • Number of events 4 • baseline to end of study participation, approximately 5 months later	0.00% 0/58 • baseline to end of study participation, approximately 5 months later
Psychiatric disorders admit/suicide attempt	0.00% 0/56 • baseline to end of study participation, approximately 5 months later	3.4% 2/58 • Number of events 2 • baseline to end of study participation, approximately 5 months later
General disorders admit/dental	1.8% 1/56 • Number of events 1 • baseline to end of study participation, approximately 5 months later	0.00% 0/58 • baseline to end of study participation, approximately 5 months later
Blood and lymphatic system disorders admit/abnrml blood	1.8% 1/56 • Number of events 1 • baseline to end of study participation, approximately 5 months later	1.7% 1/58 • Number of events 1 • baseline to end of study participation, approximately 5 months later
Psychiatric disorders admit/sub abuse	1.8% 1/56 • Number of events 1 • baseline to end of study participation, approximately 5 months later	0.00% 0/58 • baseline to end of study participation, approximately 5 months later
General disorders admit/cellulitis	0.00% 0/56 • baseline to end of study participation, approximately 5 months later	1.7% 1/58 • Number of events 1 • baseline to end of study participation, approximately 5 months later
Musculoskeletal and connective tissue disorders admit/lower extr pain	1.8% 1/56 • Number of events 1 • baseline to end of study participation, approximately 5 months later	0.00% 0/58 • baseline to end of study participation, approximately 5 months later
Psychiatric disorders admit/hallucinations	1.8% 1/56 • Number of events 1 • baseline to end of study participation, approximately 5 months later	0.00% 0/58 • baseline to end of study participation, approximately 5 months later

Other adverse events

Measure	MI Condition n=56 participants at risk motivational interview condition motivational interviewing: motivational interviewing	CI Condition n=58 participants at risk learning style interview condition learning style interviews: interview and feedback about learning style
General disorders ER/fall	1.8% 1/56 • Number of events 1 • baseline to end of study participation, approximately 5 months later	0.00% 0/58 • baseline to end of study participation, approximately 5 months later
Psychiatric disorders ER/suicidal ideation	0.00% 0/56 • baseline to end of study participation, approximately 5 months later	1.7% 1/58 • Number of events 1 • baseline to end of study participation, approximately 5 months later

Additional Information

Joanna Fiszdon, PhD

VA Connecticut Healthcare System

Phone: 2039325711

Email: joanna.fiszdon@va.gov

Results disclosure agreements

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