Clinical trial NCT05098730: Strategy Training and Pets to Promote Stroke Survivor's Cognitive Performance and Community Participation
Official title: Strategy Training and Pets to Promote Stroke Survivor's Cognitive Performance and Community Participation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed study is a single site, two-group quasi-experimental design comparing the effects of strategy training on rehabilitation engagement, cognitive performance, and community participation of home-dwelling stroke survivors living with and without pets. The investigators will also conduct qualitative interviews with participants who have pets.
Primary purpose: TREATMENT

Brief summary: The study will administer an intervention called strategy training to adult stroke survivors living in the community who do and do not have pets, and will examine the role of a pet in promoting cognitive performance and community participation outcomes.


Eligibility criteria: Stroke survivors with pets

Inclusion Criteria:

1. Primary diagnosis of acute stroke
2. At least 3 months after the stroke onset
3. Living in a community residence with a pet
4. Cognitive impairment as indicated by an Executive Interview score of 3 or higher
5. Participation restrictions as indicated by an Activity Card Sort (\<80% of pre-stroke activities)
6. Willing to participate in a 6-week program with 2 intervention sessions per week at home

Exclusion Criteria:

1. Dementia as indicated by Montreal Cognitive Assessment score of 18 or lower
2. Severe aphasia as indicated by the Boston Diagnostic Aphasia Examination Severity Score of 0 or 1
3. Self-report of a central nervous system disorder other than stroke
4. Recent drug or alcohol addiction/abuse within 3 months prior to the Mini-Neuropsychiatric Interview
5. Severe mental illness as indicated by the PRIME-MD
6. Prior exposure to strategy training
7. Currently participate in rehabilitation therapy programs

Stroke survivors without pets

Inclusion Criteria:

1. Primary diagnosis of acute stroke
2. At least 3 months after the stroke onset
3. Living in a community residence
4. Cognitive impairment as indicated by an Executive Interview score of 3 or higher
5. Participation restrictions as indicated by an Activity Card Sort (\<80% of pre-stroke activities)
6. Willing to participate in a 6-week program with 2 intervention sessions per week at home

Exclusion Criteria:

1. Dementia as indicated by Montreal Cognitive Assessment score of 18 or lower
2. Severe aphasia as indicated by the Boston Diagnostic Aphasia Examination Severity Score of 0 or 1
3. Self-report of a central nervous system disorder other than stroke
4. Recent drug or alcohol addiction/abuse within 3 months prior to the Mini-Neuropsychiatric Interview
5. Severe mental illness as indicated by the PRIME-MD
6. Prior exposure to strategy training
7. Currently participate in rehabilitation therapy programs

Primary outcomes:
measure: Mean engagement score as measured by the Pittsburgh Rehabilitation Participation Scale
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Change in attention as measured by the Color Trail Test 1
timeFrame: Baseline to 3 months
measure: Change in executive function as measured by the Color Trail Test 2
timeFrame: Baseline to 3 months
measure: Change in community participation as measure by Community Participation Indicators score
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Naor Domotor, PhD
role: PRINCIPAL_INVESTIGATOR
References: