Ready, Set, Goal: Motivation and Cognition in Stroke Patients (ACE)
Primary Purpose
Stroke, Ischemic
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Goal-Setting Instructions
Standard Instructions
Sponsored by
About this trial
This is an interventional other trial for Stroke, Ischemic focused on measuring Cognition, Apathy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Marked aphasia
- Marked neglect
- Severe visual impairment
- Inability to complete 1 hour of cognitive testing in English.
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard Instructions
Goal Setting Instructions
Arm Description
Participants will receive standard instructions for cognitive tasks.
Participants will receive goal-setting instructions for cognitive tasks.
Outcomes
Primary Outcome Measures
Controlled Oral Word Association Task
Participant performance on Controlled Oral Word Association Task in goal setting instructions group compared to standard instruction group.
Secondary Outcome Measures
Motivation Level
Participant self-reported motivation level in goal setting instruction group versus standard instruction group.
Cognitive Performance on Semantic Fluency Test
Participant performance on Semantic Fluency Test in goal setting instructions group compared to standard instruction group.
Digit Span Test
Participant performance on Digit Span Test in goal setting instructions group compared to standard instruction group.
California Verbal Learning Test-II
Participant performance on California Verbal Learning Test-II in goal setting instructions group compared to standard instruction group.
Trail Making Test
Participant performance on Trail Making Test in goal setting instructions group compared to standard instruction group.
Full Information
NCT ID
NCT03511300
First Posted
February 12, 2018
Last Updated
October 25, 2019
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
University of Ottawa
1. Study Identification
Unique Protocol Identification Number
NCT03511300
Brief Title
Ready, Set, Goal: Motivation and Cognition in Stroke Patients
Acronym
ACE
Official Title
Ready Set Goal: A Randomized Controlled Trial Examining Motivation and Cognition in Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
University of Ottawa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Cognition, Apathy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Masking Description
Participants will not be told which group they are assigned to.
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Instructions
Arm Type
Placebo Comparator
Arm Description
Participants will receive standard instructions for cognitive tasks.
Arm Title
Goal Setting Instructions
Arm Type
Experimental
Arm Description
Participants will receive goal-setting instructions for cognitive tasks.
Intervention Type
Behavioral
Intervention Name(s)
Goal-Setting Instructions
Intervention Description
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'.")
Intervention Type
Behavioral
Intervention Name(s)
Standard Instructions
Intervention Description
Participants in this group will receive the standardized instructions for completing the tests, as outlined in the test appendices.
Primary Outcome Measure Information:
Title
Controlled Oral Word Association Task
Description
Participant performance on Controlled Oral Word Association Task in goal setting instructions group compared to standard instruction group.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Motivation Level
Description
Participant self-reported motivation level in goal setting instruction group versus standard instruction group.
Time Frame
2 minutes
Title
Cognitive Performance on Semantic Fluency Test
Description
Participant performance on Semantic Fluency Test in goal setting instructions group compared to standard instruction group.
Time Frame
10 minutes
Title
Digit Span Test
Description
Participant performance on Digit Span Test in goal setting instructions group compared to standard instruction group.
Time Frame
10 minutes
Title
California Verbal Learning Test-II
Description
Participant performance on California Verbal Learning Test-II in goal setting instructions group compared to standard instruction group.
Time Frame
10 minutes
Title
Trail Making Test
Description
Participant performance on Trail Making Test in goal setting instructions group compared to standard instruction group.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Marked aphasia
Marked neglect
Severe visual impairment
Inability to complete 1 hour of cognitive testing in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keera Fishman, B.Sc
Organizational Affiliation
Sunnybrook Health Sciences Centre/ University of Ottawa
Official's Role
Study Director
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to make IPD available.
Citations:
PubMed Identifier
18005498
Citation
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.
Results Reference
background
PubMed Identifier
13263471
Citation
REITAN 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.
Results Reference
background
PubMed Identifier
16018151
Citation
Darvesh 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.
Results Reference
background
Citation
Delis, D. C., Kramer, J. H, Kaplan, E., & Ober, B. A. (2000). California Verbal Learning Test - Second edition. Adult version: Manual. San Antonio: Psychological Corporation.
Results Reference
background
Citation
Benton, A. L., & Hamsher, K. (1976). Multilingual Aphasia Examination. Iowa City, Iowa: University of Iowa.
Results Reference
background
Citation
Wechsler, D. (2008). Wechsler Adult Intelligence Scale-Fourth Edition. San Antonio, TX: Pearson.
Results Reference
background
PubMed Identifier
1821241
Citation
Marin RS. Apathy: a neuropsychiatric syndrome. J Neuropsychiatry Clin Neurosci. 1991 Summer;3(3):243-54. doi: 10.1176/jnp.3.3.243.
Results Reference
background
PubMed Identifier
33467876
Citation
Fishman 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.
Results Reference
derived
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Ready, Set, Goal: Motivation and Cognition in Stroke Patients
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