Stroke, IschemicACENCT03511300
Ready, Set, Goal: Motivation and Cognition in Stroke Patients
A study testing Goal-Setting Instructions and Standard Instructions in people with Stroke, Ischemic, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Apathy is a syndrome of reduced motivation, characterized by diminished goal-directed behaviours (e.g., lack of effort), decreased goal-oriented cognitions (e.g., lack of interest) and blunted affect. Apathy is present in 20-50% of individuals after experiencing a stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Goal-Setting Instructions and Standard Instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2018to 25 Oct 2019
- 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
- Patient attending Secondary Stroke Prevention Clinic
- Ischemic Stroke
- Presenting at least 3 months after stroke
- Modified Rankin Scale Score of at least 4
- Fluent in English
Who cannot join
- Marked aphasia
- Marked neglect
- Severe visual impairment
- Inability to complete 1 hour of cognitive testing in English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ready Set Goal: A Randomized Controlled Trial Examining Motivation and Cognition in Stroke Patients
Apathy is a syndrome of reduced motivation, characterized by diminished goal-directed behaviours (e.g., lack of effort), decreased goal-oriented cognitions (e.g., lack of interest) and blunted affect. Apathy is present in 20-50% of individuals after experiencing a stroke. Despite the detrimental impact of reduced goal-directed behaviours and cognitions on activities of daily living and cognition in stroke patients, interventions for increasing motivation (reducing apathy) have yet to be examined in this population. This study will examine the effect of goal-setting instructions on cognitive performance in stroke patients. The investigators hypothesize that in stroke patients, goal-setting instructions will improve cognitive performance relative to standard instructions. If goal-setting instructions are effective in improving cognitive performance, it may indicate that treatments targeting apathy could serve as a novel way to improve cognitive outcomes and enhance patient quality of life post-stroke.
Read the detailed description
The study is a single-blind randomized controlled trial. It employs a mixed design, with a between-subjects variable (goal-setting instructions versus standardized instructions) and a within-subjects variable (pre-post instructional manipulation). It is a one-time intervention lasting 1-2 hours. Investigators plan to enroll 72 patients in this study. All participants will complete neuropsychological measures to assess their baseline performance. The baseline measures include Trial 1 of the CVLT-II Alternate Form, the Digit Span Test, Center for Epidemiologic Studies Depression Scale, Controlled Oral Word Association Test, Semantic Fluency Test, Apathy Evaluation Scale and Trail Making Test. After the baseline measures are completed, all participants will rate their level of motivation on a scale from 1 (extremely unmotivated) to 100 (extremely motivated), which will act as a pre-manipulation check measure, their level of fatigue on a scale from 1 (extremely not fatigued) to 100 (extremely fatigued), and their level of anxiety from 1 (extremely not anxious) to 100 (extremely anxious; 1 minute).
After completing the baseline measures and rating scales, half (n = 36) of the participants will be randomly assigned to the goal-setting instruction group ("goal-setting group"). Motivation will be enhanced by asking participants to perform 20% better than their previous performance on a similar task, and translating that into a number (e.g., "On this task, you generated 10 words when I asked you to name as many words as you could that start with the letter "F." Now, for the next letter, I want you to generate 12 words."). The remainder of the participants (n = 36) will be assigned to the "standard instruction group," where they will only receive the standardized instructions for completing the tests.
- Conditions
- Stroke, Ischemic
- Being tested
- Goal-Setting Instructions, Standard Instructions
- Keywords
- Cognition, Apathy
- Medical subject headings
- Ischemic Stroke, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Setting InstructionsBehavioural
In the goal-setting instruction condition, participants will be asked to increase their performance by 20% from the previous similar test (e.g., "On this task, you generated 10 words when I asked you to name as many words as you could that start with the letter 'F.' Now, I want you to aim to generate at least 12 words for the letter 'F'.")
Standard InstructionsBehavioural
Participants in this group will receive the standardized instructions for completing the tests, as outlined in the test appendices.
| Study group | Role | What they receive |
|---|---|---|
| Standard Instructions | Placebo comparator | Participants will receive standard instructions for cognitive tasks. Receives: Behavioral: Standard Instructions |
| Goal Setting Instructions | Experimental | Participants will receive goal-setting instructions for cognitive tasks. Receives: Behavioral: Goal-Setting Instructions; Behavioral: Standard Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controlled Oral Word Association Task
Participant performance on Controlled Oral Word Association Task in goal setting instructions group compared to standard instruction group.
Measured: 10 minutes
Secondary outcomes (5)
Motivation Level
Participant self-reported motivation level in goal setting instruction group versus standard instruction group.
Measured: 2 minutes
Cognitive Performance on Semantic Fluency Test
Participant performance on Semantic Fluency Test in goal setting instructions group compared to standard instruction group.
Measured: 10 minutes
Digit Span Test
Participant performance on Digit Span Test in goal setting instructions group compared to standard instruction group.
Measured: 10 minutes
California Verbal Learning Test-II
Participant performance on California Verbal Learning Test-II in goal setting instructions group compared to standard instruction group.
Measured: 10 minutes
Trail Making Test
Participant performance on Trail Making Test in goal setting instructions group compared to standard instruction group.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Jun 2018
- Primary completion1 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a single-blind randomized controlled trial. It employs a mixed design, with a between-subjects (instruction type: goal-setting or standard instructions) and a within subjects (pre- and post-instruction manipulation) variable. Seventy-two stroke patients will undergo baseline cognitive testing to assess their verbal ability, learning, memory, attention, visuospatial ability, and exective functioning, with standardized instructions. After completing baseline testing and ratings of apathy (AES), depression (CES-D), anxiety, motivation, and fatigue, participants (N = 72) will either be assigned to the standardized instruction condition (n = 30) or the goal-setting instruction condition (n = 30).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Principal investigator, Dr. Richard H. Swartz, Sunnybrook Health Sciences Centre
- Investigators
- Keera Fishman, B.Sc, Study director, Sunnybrook Health Sciences Centre/ University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511300
- Sponsor's protocol ID
- 001
- Acronym
- ACE
- Status last verified
- Oct 2019
- First submitted
- 12 Feb 2018
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available.
Publications
Scheurich A, Fellgiebel A, Schermuly I, Bauer S, Wolfges R, Muller MJ. Experimental evidence for a motivational origin of cognitive impairment in major depression. Psychol Med. 2008 Feb;38(2):237-46. doi: 10.1017/S0033291707002206. Epub 2007 Nov 16.
PubMed 18005498REITAN RM. The relation of the trail making test to organic brain damage. J Consult Psychol. 1955 Oct;19(5):393-4. doi: 10.1037/h0044509. No abstract available.
PubMed 13263471Darvesh S, Leach L, Black SE, Kaplan E, Freedman M. The behavioural neurology assessment. Can J Neurol Sci. 2005 May;32(2):167-77. doi: 10.1017/s0317167100003930.
PubMed 16018151Delis, D. C., Kramer, J. H, Kaplan, E., & Ober, B. A. (2000). California Verbal Learning Test - Second edition. Adult version: Manual. San Antonio: Psychological Corporation.
Benton, A. L., & Hamsher, K. (1976). Multilingual Aphasia Examination. Iowa City, Iowa: University of Iowa.
Wechsler, D. (2008). Wechsler Adult Intelligence Scale-Fourth Edition. San Antonio, TX: Pearson.
Marin RS. Apathy: a neuropsychiatric syndrome. J Neuropsychiatry Clin Neurosci. 1991 Summer;3(3):243-54. doi: 10.1176/jnp.3.3.243.
PubMed 1821241Fishman KN, Ashbaugh AR, Swartz RH. Goal Setting Improves Cognitive Performance in a Randomized Trial of Chronic Stroke Survivors. Stroke. 2021 Jan;52(2):458-470. doi: 10.1161/STROKEAHA.120.032131. Epub 2021 Jan 20.
PubMed 33467876
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ready Set Goal: A Randomized Controlled Trial Examining Motivation and Cognition in Stroke Patients
- ClinicalTrials.gov ID
- NCT03511300
- Acronym / sponsor ID
- ACE / 001
- Conditions
- Stroke, Ischemic
- Keywords
- Cognition, Apathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 27 Apr 2018 (actual)
- 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.
Apathy is a syndrome of reduced motivation, characterized by diminished goal-directed behaviours (e.g., lack of effort), decreased goal-oriented cognitions (e.g., lack of interest) and blunted affect. Apathy is present in 20-50% of individuals after experiencing a stroke. Despite the detrimental impact of reduced goal-directed behaviours and cognitions on activities of daily living and cognition in stroke patients, interventions for increasing motivation (reducing apathy) have yet to be examined in this population. This study will examine the effect of goal-setting instructions on cognitive performance in stroke patients. The investigators hypothesize that in stroke patients, goal-setting instructions will improve cognitive performance relative to standard instructions. If goal-setting instructions are effective in improving cognitive performance, it may indicate that treatments targeting apathy could serve as a novel way to improve cognitive outcomes and enhance patient quality of life post-stroke.
Detailed description
The study is a single-blind randomized controlled trial. It employs a mixed design, with a between-subjects variable (goal-setting instructions versus standardized instructions) and a within-subjects variable (pre-post instructional manipulation). It is a one-time intervention lasting 1-2 hours. Investigators plan to enroll 72 patients in this study. All participants will complete neuropsychological measures to assess their baseline performance. The baseline measures include Trial 1 of the CVLT-II Alternate Form, the Digit Span Test, Center for Epidemiologic Studies Depression Scale, Controlled Oral Word Association Test, Semantic Fluency Test, Apathy Evaluation Scale and Trail Making Test. After the baseline measures are completed, all participants will rate their level of motivation on a scale from 1 (extremely unmotivated) to 100 (extremely motivated), which will act as a pre-manipulation check measure, their level of fatigue on a scale from 1 (extremely not fatigued) to 100 (extremely fatigued), and their level of anxiety from 1 (extremely not anxious) to 100 (extremely anxious; 1 minute).
After completing the baseline measures and rating scales, half (n = 36) of the participants will be randomly assigned to the goal-setting instruction group ("goal-setting group"). Motivation will be enhanced by asking participants to perform 20% better than their previous performance on a similar task, and translating that into a number (e.g., "On this task, you generated 10 words when I asked you to name as many words as you could that start with the letter "F." Now, for the next letter, I want you to generate 12 words."). The remainder of the participants (n = 36) will be assigned to the "standard instruction group," where they will only receive the standardized instructions for completing the tests.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is a single-blind randomized controlled trial. It employs a mixed design, with a between-subjects (instruction type: goal-setting or standard instructions) and a within subjects (pre- and post-instruction manipulation) variable. Seventy-two stroke patients will undergo baseline cognitive testing to assess their verbal ability, learning, memory, attention, visuospatial ability, and exective functioning, with standardized instructions. After completing baseline testing and ratings of apathy (AES), depression (CES-D), anxiety, motivation, and fatigue, participants (N = 72) will either be assigned to the standardized instruction condition (n = 30) or the goal-setting instruction condition (n = 30).
| Arm | Type | Receives |
|---|---|---|
| Standard Instructions | Placebo comparator | Behavioral: Standard InstructionsParticipants will receive standard instructions for cognitive tasks. |
| Goal Setting Instructions | Experimental | Behavioral: Goal-Setting Instructions, Behavioral: Standard InstructionsParticipants will receive goal-setting instructions for cognitive tasks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient attending Secondary Stroke Prevention Clinic
- Ischemic Stroke
- Presenting at least 3 months after stroke
- Modified Rankin Scale Score of at least 4
- Fluent in English
Key exclusion criteria (4 listed)
- Marked aphasia
- Marked neglect
- Severe visual impairment
- Inability to complete 1 hour of cognitive testing in English.
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 |
|---|---|---|
| Goal-Setting InstructionsIn the goal-setting instruction condition, participants will be asked to increase their performance by 20% from the previous similar test (e.g., "On this task, you generated 10 words when I asked you to name as many words as you could that start with the letter 'F.' Now, I want you to aim to generate at least 12 words for the letter 'F'.") | Behavioural | Goal Setting Instructions |
| Standard InstructionsParticipants in this group will receive the standardized instructions for completing the tests, as outlined in the test appendices. | Behavioural | Goal Setting Instructions, Standard Instructions |
Primary outcome
Controlled Oral Word Association Task
Time frame: 10 minutes
Participant performance on Controlled Oral Word Association Task in goal setting instructions group compared to standard instruction group.
5 secondary outcomes
Motivation Level
Time frame: 2 minutes
Cognitive Performance on Semantic Fluency Test
Time frame: 10 minutes
Digit Span Test
Time frame: 10 minutes
California Verbal Learning Test-II
Time frame: 10 minutes
Trail Making Test
Time frame: 10 minutes
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 29 Oct 2019.
- Background: PubMed 18005498Scheurich A, Fellgiebel A, Schermuly I, Bauer S, Wolfges R, Muller MJ. Experimental evidence for a motivational origin of cognitive impairment in major depression. Psychol Med. 2008 Feb;38(2):237-46. doi: 10.1017/S0033291707002206. Epub 2007 Nov 16.
- Background: PubMed 13263471REITAN RM. The relation of the trail making test to organic brain damage. J Consult Psychol. 1955 Oct;19(5):393-4. doi: 10.1037/h0044509. No abstract available.
- Background: PubMed 16018151Darvesh S, Leach L, Black SE, Kaplan E, Freedman M. The behavioural neurology assessment. Can J Neurol Sci. 2005 May;32(2):167-77. doi: 10.1017/s0317167100003930.
- BackgroundDelis, D. C., Kramer, J. H, Kaplan, E., & Ober, B. A. (2000). California Verbal Learning Test - Second edition. Adult version: Manual. San Antonio: Psychological Corporation.
- BackgroundBenton, A. L., & Hamsher, K. (1976). Multilingual Aphasia Examination. Iowa City, Iowa: University of Iowa.
- BackgroundWechsler, D. (2008). Wechsler Adult Intelligence Scale-Fourth Edition. San Antonio, TX: Pearson.
- Background: PubMed 1821241Marin RS. Apathy: a neuropsychiatric syndrome. J Neuropsychiatry Clin Neurosci. 1991 Summer;3(3):243-54. doi: 10.1176/jnp.3.3.243.
- Derived from this study: PubMed 33467876Fishman KN, Ashbaugh AR, Swartz RH. Goal Setting Improves Cognitive Performance in a Randomized Trial of Chronic Stroke Survivors. Stroke. 2021 Jan;52(2):458-470. doi: 10.1161/STROKEAHA.120.032131. Epub 2021 Jan 20.
- Individual participant dataSharing planned: No. No plan to make IPD available.
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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.
Keera Fishman, B.Sc study director
Sunnybrook Health Sciences Centre/ University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Setting Instructions and Standard Instructions in people with Stroke, Ischemic, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 5 inclusion and 4 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 29 Oct 2019. 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 Canada. 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?
Controlled Oral Word Association Task (time frame: 10 minutes). 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 NCT03511300, which also lists 8 linked publications.
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 29 Oct 2019.