Trial Outcomes & Findings for Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia (NCT NCT00455663)

Results Overview

% medication taken as determined by unannounced pill counts conducted in the home on 2 occasions in each 3 month period. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

105 participants

Primary outcome timeframe

1 final score combined for endpoint for 9 months of treatment and 6 months follow up

Results posted on

2015-06-15

Participant Flow

Subjects were outpatients recruited in 2 streams. Ninety-nine were recruited at the time of discharge from an inpatient psychiatric facility and followed for 3 months after discharge prior to baseline assessments and randomization

Of the 99 recruited at hospital Discharge:11 rehospitalized,9 not located,8 withdrew consent,4 incarcerated,3 unable to complete assessments,2 aggressive behavior,2 medication,1 deceased Of 57 outpatient recruits;4 withdrew consent,1 unable to complete assessments,1 medication, 1 unsafe,1 aggression, 1 substance abuse, 1 deceased, 1 moved

Participant milestones

Participant milestones
Measure	Cognitive Adaptation Training In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.	Pharm-Cognitive Adaptation Training Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.	Treatment As Usual Medication follow up and limited case management provided by local mental health authority
Overall Study STARTED	37	36	32
Overall Study COMPLETED	34	32	29
Overall Study NOT COMPLETED	3	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Adaptive Training for Improving Medication Adherence, Symptoms, and Function in People With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Adaptation Training n=34 Participants In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.	Pharm-Cognitive Adaptation Training n=32 Participants Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.	Treatment As Usual n=29 Participants Medication follow up and limited case management provided by local mental health authority	Total n=95 Participants Total of all reporting groups
Age, Continuous	37 years STANDARD_DEVIATION 9.4 • n=5 Participants	40 years STANDARD_DEVIATION 11.1 • n=7 Participants	39 years STANDARD_DEVIATION 22.1 • n=5 Participants	39.0 years STANDARD_DEVIATION 10.7 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	18 Participants n=7 Participants	11 Participants n=5 Participants	41 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants	54 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 final score combined for endpoint for 9 months of treatment and 6 months follow up

% medication taken as determined by unannounced pill counts conducted in the home on 2 occasions in each 3 month period. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.

Outcome measures

Outcome measures
Measure	Pharm-Cognitive Adaptation Training n=32 Participants Environmental supports to assist in medication and appointment adherence	Cognitive Adaptation Training n=34 Participants Environmental supports for all independent living skills	Treatment as Usual n=29 Participants medication management and case management in the community mental health center
Medication Adherence-pill Count	80.8 percentage of medication taken Standard Error 4.5	81.43 percentage of medication taken Standard Error 3.7	57.3 percentage of medication taken Standard Error 3.7

PRIMARY outcome

Timeframe: 1 final endpoint least sq mean combining 9 months of treatment 6 months of follow up

Positive symptoms subscale of the Brief Psychiatric Rating Scale includes delusions, hallucinations, conceptual disorganization and suspiciousness-Mean score averaging these items, variability 1-7. Higher scores reflect higher level of symptoms. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.

Outcome measures

Outcome measures
Measure	Pharm-Cognitive Adaptation Training n=34 Participants Environmental supports to assist in medication and appointment adherence	Cognitive Adaptation Training n=32 Participants Environmental supports for all independent living skills	Treatment as Usual n=29 Participants medication management and case management in the community mental health center
Positive Symptoms	2.3 units on a scale Standard Error .15	2.5 units on a scale Standard Error .17	2.3 units on a scale Standard Error .15

PRIMARY outcome

Timeframe: 1 endpoint ls means combining 9 months of treatment and 6 months follow up

Scores range from 0 to 100 with higher scores reflecting better functioning. 1 Final score for endpoint created by averaging scores for 9 months of treatment and 6 months of follow up.

Outcome measures

Outcome measures
Measure	Pharm-Cognitive Adaptation Training n=34 Participants Environmental supports to assist in medication and appointment adherence	Cognitive Adaptation Training n=32 Participants Environmental supports for all independent living skills	Treatment as Usual n=29 Participants medication management and case management in the community mental health center
Social and Occupational Functioning Scale Score	50.8 units on a scale Standard Error 1.1	45.2 units on a scale Standard Error 1.3	42.6 units on a scale Standard Error 1.2

PRIMARY outcome

Timeframe: 9 months of treatment 6 months follow up

Population: Number of participants meeting bprs criteria for at least partial remission.scores on 3 of the 4 BPRS psychosis items had to be 4 or lower indicating moderate symptoms only.

A relapse was scored (only for patients meeting criteria for remission) if scores on any of the 4 items assessing positive symptoms on the Brief Psychiatric Rating Scale increased a minimum of 2 points to a score of 5 or higher, if the patient was suicidal, if the patient was hospitalized, or if the patient was unable to care for themselves without continual supervision

Outcome measures

Outcome measures
Measure	Pharm-Cognitive Adaptation Training n=25 Participants Environmental supports to assist in medication and appointment adherence	Cognitive Adaptation Training n=23 Participants Environmental supports for all independent living skills	Treatment as Usual n=21 Participants medication management and case management in the community mental health center
Number of Patients Surviving Without Relapse/Exacerbation	15 participants	14 participants	4 participants

Adverse Events

Cognitive Adaptation Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pharm-Cognitive Adaptation Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment As Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dawn I. Velligan

UTHSCSA

Phone: 210-567-5508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place