CO-OPCO-OPNCT02755805

CO-OPerative Training for Stroke Rehabilitation

A study testing CO-OP in people with CO-OP and Attention Control, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Cognitive impairments occur frequently after stroke, and are associated with significant long-term activities of daily living (ADL) disability and poor quality of life. This research study will undertake an innovative approach addressing cognitive impairments, by examining a new patient-centered functionally-relevant… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: CO-OP, Attention Control
What is being tested?: CO-OP
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Jul 2009to Dec 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

primary diagnosis of acute stroke
admission to acute inpatient rehabilitation
impairment in cognitive functions (Quick Executive Interview ≥ 3)

Who cannot join

dementia diagnosis (as indicated in the medical record)
severe aphasia as indicated by score ≥ 2 on the Boston Diagnostic Aphasia Examination (3rd Edition) Severity Rating Scale (BDAE-3)
current major depressive disorder (unless treated and in partial remission), bipolar or any other psychotic disorder (Primary Care Evaluation of Mental Disorders)
drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)
anticipated length of stay less than 5 days

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15260

Other trials in United States

About this study

Official title: CO-OPerative Training For Stroke Rehabilitation: A Phase II Trial Examining Meta-Cognitive Strategy Training in Acute Stroke Rehabilitation

Read the detailed description

Cognitive impairments are characterized by problems sustaining attention in distracting conditions, shifting attention between different task demands, and using working memory to consistently execute intended actions, and as a result limit the ability to execute routine ADLs. Presently there are no interventions that have demonstrated robust effectiveness in reducing disability among individuals with cognitive impairments after stroke. Recent findings suggest that individuals with cognitive impairments may experience ADL disability in part because they have difficulty engaging in, and benefiting from rehabilitation programs as they are currently delivered. In other words, individuals with cognitive impairment, due to the nature of their impairments, have difficulty learning and applying adaptive strategies as they are currently provided during traditional rehabilitation training. Therefore, interventions that train individuals with cognitive impairments a new way to learn and apply adaptive strategies may help them benefit from rehabilitation programs and reduce long-term disability. Cognitive Orientation to daily Occupation Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Therefore, CO-OP teaches individuals to "take charge" of their rehabilitation, and develop adaptive behaviors to "work around" cognitive impairments to meet their goals. The proposed project examines whether CO-OP facilitates reductions in ADL disability and improvements in rehabilitation engagement among individuals with cognitive impairments after acute stroke.

Conditions: CO-OP, Attention Control
Being tested: CO-OP, Attention Control
Keywords: Stroke, Rehabilitation, Cognition, Intervention, Strategy training
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CO-OPBehavioural
Also called Strategy Training
Attention ControlBehavioural
Also called Reflective Listening

Study groups in NCT02755805
Study group	Role	What they receive
CO-OP	Experimental	Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training. Receives: Behavioral: CO-OP
Attention Control	Placebo comparator	The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities. Receives: Behavioral: Attention Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models.
The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point.
Measured: Baseline, rehabilitation discharge, month 3, month 6

Secondary outcomes (3)

Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)
Difference mean scaled scores (Color Word Interference Inhibition Scale) between groups over time using mixed effects models.
The Color Word Interference Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point.
Measured: Baseline, 3 months, 6 months
Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)
Difference between groups in mean scaled scores (Color Word Interference Switching Scale) over time using mixed effects models.
The Cognitive Flexibility Scale raw scores were converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point.
Measured: Baseline, 3 months, 6 months
Differences in Apathy Symptoms Between Groups Over Time
Difference in mean Apathy Evaluation Scale total scores were examined between groups over time using repeated measures fixed effects models.
The Apathy Evaluation Scale measures lack of motivation or interest in goal-directed activities. The scale has 18 items yielding a total score of 18 (indicating absence of apathy) to 72 (indicating severe apathy). Total scores were generated for each participant at each time, and mean scores were computed for each group at each time point.
Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Dec 2012

First posted29 Apr 2016 (estimated)
Study startJul 2009
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CO-OPStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02755805
Sponsor's protocol ID: PRO09010473
Other IDs: K12HD055931
Acronym: CO-OP
Status last verified: Oct 2017
First submitted: 25 Apr 2016
Last updated: 6 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: There is no current plan to share individual participant data at this time.

Publications

Kringle EA, Terhorst L, Butters MA, Skidmore ER. Clinical Predictors of Engagement in Inpatient Rehabilitation Among Stroke Survivors With Cognitive Deficits: An Exploratory Study. J Int Neuropsychol Soc. 2018 Jul;24(6):572-583. doi: 10.1017/S1355617718000085. Epub 2018 Mar 19.
PubMed 29552996

Study at a glance

From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CO-OPerative Training For Stroke Rehabilitation: A Phase II Trial Examining Meta-Cognitive Strategy Training in Acute Stroke Rehabilitation
ClinicalTrials.gov ID: NCT02755805
Acronym / sponsor ID: CO-OP / PRO09010473
Conditions: CO-OP, Attention Control
Keywords: Stroke, Rehabilitation, Cognition, Intervention, Strategy training
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Jul 2009
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 29 Apr 2016 (estimated)
Results: Posted 20 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CO-OP	Experimental	Behavioral: CO-OPCognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.
Attention Control	Placebo comparator	Behavioral: Attention ControlThe attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

primary diagnosis of acute stroke
admission to acute inpatient rehabilitation
impairment in cognitive functions (Quick Executive Interview ≥ 3)

Key exclusion criteria (5 listed)

dementia diagnosis (as indicated in the medical record)
severe aphasia as indicated by score ≥ 2 on the Boston Diagnostic Aphasia Examination (3rd Edition) Severity Rating Scale (BDAE-3)
current major depressive disorder (unless treated and in partial remission), bipolar or any other psychotic disorder (Primary Care Evaluation of Mental Disorders)
drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)
anticipated length of stay less than 5 days

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CO-OPAlso: Strategy Training	Behavioural	CO-OP
Attention ControlAlso: Reflective Listening	Behavioural	Attention Control

Primary outcome

Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Time frame: Baseline, rehabilitation discharge, month 3, month 6
Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point.

3 secondary outcomes

Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)
Time frame: Baseline, 3 months, 6 months
Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)
Time frame: Baseline, 3 months, 6 months
Differences in Apathy Symptoms Between Groups Over Time
Time frame: Baseline, 3 months, 6 months

Results and safety

Results posted to the registry on 20 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CO-OP	15	13
Attention Control	15	11

Primary outcome: Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time

Time frame: Baseline, rehabilitation discharge, month 3, month 6. Mean (Standard Error). Unit: units on a scale

Measure	CO-OP n = 15	Attention Control n = 15
Baseline Scores	65.27 (2.80)	62.60 (4.28)
Discharge Scores	86.80 (3.27)	80.53 (5.73)
Month 3	109.69 (2.61)	91.23 (7.48)
Month 6	113.31 (2.48)	95.27 (7.60)

CO-OP vs Attention Control: Cohen's d effect size at month 6: 1.11, p = 0.007, Mixed Models Analysis

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CO-OP	0 of 15 (0%)	0 of 15 (0%)	Not reported
Attention Control	0 of 15 (0%)	0 of 15 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29552996Kringle EA, Terhorst L, Butters MA, Skidmore ER. Clinical Predictors of Engagement in Inpatient Rehabilitation Among Stroke Survivors With Cognitive Deficits: An Exploratory Study. J Int Neuropsychol Soc. 2018 Jul;24(6):572-583. doi: 10.1017/S1355617718000085. Epub 2018 Mar 19.
Individual participant dataSharing planned: No. There is no current plan to share individual participant data at this time.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth R Skidmore, PhD, OTR/L principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CO-OP in people with CO-OP and Attention Control, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time (time frame: Baseline, rehabilitation discharge, month 3, month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02755805, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017; AzTrials last refreshed its copy on 4 Nov 2026.