Strategy TrainingADAPTSNCT01934621
Adapting Daily Activity Performance Through Strategy Training
A study testing Strategy Training in people with Strategy Training and Attention Control, run by University of Pittsburgh at 1 site in United States.
Trial summary
Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Strategy Training, Attention Control
- What is being tested?
- Strategy Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 higher order cognitive functions (EXIT-14 ≥ 3)
Who cannot join
- pre-stroke diagnosis of dementia in the medical record
- inability to follow two- step commands 80% of the time
- severe aphasia (BDAE ≤ 1)
- current major depressive, bipolar, or psychotic disorder
- drug or alcohol abuse within 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Closing the Gap: Early Intervention for Cognitive Disability After Stroke
Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. The proposed study examines a novel intervention, strategy training, that shows promise for helping individuals with stroke-related cognitive impairments reduce disability in daily tasks, which may lead to reductions in healthcare costs. We predict that strategy training will result in significantly greater independence 6 months after stroke compared to an attention control intervention, and that strategy training may reduce cognitive impairments.
- Conditions
- Strategy Training, Attention Control
- Being tested
- Strategy Training, Attention Control
- Keywords
- Stroke, Rehabilitation, Cognition, Disability
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy TrainingBehavioural
Attention ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Strategy Training | Experimental | Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice. Participants use printed workbooks to learn and apply this method. Receives: Behavioral: Strategy Training |
| Attention Control | Placebo comparator | The attention control intervention will control for the non-specific effects of strategy training. The therapists will administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. In lieu of the strategy training workbook materials, participants will complete a daily journal, and discuss their entries during attention control sessions. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Independence with Daily Activities
Moderate effect size of difference between groups in independence (measured with the Functional Independence Measure)
Measured: Baseline to Month 6
Secondary outcomes (1)
Change in Executive Functions
Moderate effect size of difference between groups in independence (measured with selected indices of the Delis-Kaplan Executive Function System)
Measured: Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2018
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Strategy TrainingStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Elizabeth R. Skidmore, PhD, OTR/L, University of Pittsburgh
- Investigators
- Elizabeth R Skidmore, PhD, OTR/L, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934621
- Sponsor's protocol ID
- PRO13070029
- Other IDs
- R01HD074693
- Acronym
- ADAPTS
- Status last verified
- Nov 2020
- First submitted
- 29 Aug 2013
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
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 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closing the Gap: Early Intervention for Cognitive Disability After Stroke
- ClinicalTrials.gov ID
- NCT01934621
- Acronym / sponsor ID
- ADAPTS / PRO13070029
- Conditions
- Strategy Training, Attention Control
- Keywords
- Stroke, Rehabilitation, Cognition, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 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
- Nov 2013 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 4 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. The proposed study examines a novel intervention, strategy training, that shows promise for helping individuals with stroke-related cognitive impairments reduce disability in daily tasks, which may lead to reductions in healthcare costs. We predict that strategy training will result in significantly greater independence 6 months after stroke compared to an attention control intervention, and that strategy training may reduce cognitive impairments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strategy Training | Experimental | Behavioral: Strategy TrainingStrategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice. Participants use printed workbooks to learn and apply this method. |
| Attention Control | Placebo comparator | Behavioral: Attention ControlThe attention control intervention will control for the non-specific effects of strategy training. The therapists will administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. In lieu of the strategy training workbook materials, participants will complete a daily journal, and discuss their entries during attention control sessions. |
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 higher order cognitive functions (EXIT-14 ≥ 3)
Key exclusion criteria (5 listed)
- pre-stroke diagnosis of dementia in the medical record
- inability to follow two- step commands 80% of the time
- severe aphasia (BDAE ≤ 1)
- current major depressive, bipolar, or psychotic disorder
- drug or alcohol abuse within 3 months
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 |
|---|---|---|
| Strategy Training | Behavioural | Strategy Training |
| Attention Control | Behavioural | Attention Control |
Primary outcome
Change in Independence with Daily Activities
Time frame: Baseline to Month 6
Moderate effect size of difference between groups in independence (measured with the Functional Independence Measure)
1 secondary outcome
Change in Executive Functions
Time frame: Baseline to Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- 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.
Related trials for Strategy Training
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
Enrolling by invitation
To Drill or Not to Drill: Do Memory Drills Help Train the Ability to "Remember to Remember" in Veterans
Memory Deficit
Recruiting
Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors
Stroke, Chronic Phase of Disease
Recruiting
Cognitive Rehabilitation Following Breast Cancer Treatment
Breast Cancer Female
Not yet recruitingPhase 4
Efficacy and Safety Study of Digital Cognitive Training and PCSK9 Inhibitor-Enhanced Lipid-lowering Strategy in Patients With Intracranial Atherosclerotic Stenosis: A 2x2 Factorial, Randomized, Parallel-Group, Multicenter Trial
Intracranial Arteriosclerosis, Cognitive Impairment
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 Strategy Training in people with Strategy Training 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 5 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Independence with Daily Activities (time frame: Baseline to 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 NCT01934621, 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 5 Nov 2020.