Strategy Training and Pets to Promote Stroke Survivor's Cognitive Performance and Community Participation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Strategy Training

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naor Domotor, PhD; Phone Number: 4123836617; Email: NAD129@pitt.edu
• Study Contact Backup: Name: Elizabeth Skidmore, PhD; Phone Number: 4123836617; Email: skidmore@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh
      • Contact: Minmei Shih, PhD, OTR/L; Phone Number: 412-383-6752; Email: mis235@pitt.edu
      • Contact: Elizabeth R Skidmore, PhD, OTR/L; Phone Number: (412) 383-6617; Email: skidmore@pitt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke survivors with pets; Stroke survivors with pets will receive strategy training for 10-15 sessions, 45 minutes each session, delivered by a trained occupational therapist in the home.	Behavioral: Strategy Training; Strategy training is comprised of participant-selected activity based goals, self evaluation, global problem solving strategies, and therapist-delivered guided training. The strategy training therapist will guide participants using prompting questions, as well as work sheets that facilitate learning and aid the participants in implementing the process.
Active Comparator: Stroke survivors without pets; Stroke survivors without pets will receive strategy training for 10-15 sessions, 45 minutes each session, delivered by a trained occupational therapist in the home.	Behavioral: Strategy Training; Strategy training is comprised of participant-selected activity based goals, self evaluation, global problem solving strategies, and therapist-delivered guided training. The strategy training therapist will guide participants using prompting questions, as well as work sheets that facilitate learning and aid the participants in implementing the process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean engagement score as measured by the Pittsburgh Rehabilitation Participation Scale	The scale is a valid and reliable criterion referenced measure that assesses engagement in rehabilitation therapy sessions. Each session is scored by the occupational therapist, 1 (no participation, refusal) to 6 (excellent participation). Scores are averaged across the 10-15 intervention sessions to generate the mean engagement score.	Baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in attention as measured by the Color Trail Test 1	This measure assesses perceptual tracking, sustained attention and grapho-motor skills. It is a pencil and paper, timed test. Completion time in seconds for each task is recorded, with a lower score representing better function. Change in attention will be calculated by subtracting the time to do the task at baseline from the time to do the task at 3 months.	Baseline to 3 months
Change in executive function as measured by the Color Trail Test 2	This measure assesses divided attention and sequencing skills, which are executive function performance. It is a pencil and paper, timed test of effortful executive processing abilities that assesses the ability to alternate between two colors. Completion time in seconds for each task is recorded, with a lower score representing better function. Change in executive function will be calculated by subtracting the time to do the task at baseline from the time to do the task at 3 months.	Baseline to 3 months
Change in community participation as measure by Community Participation Indicators score	This participant reported questionnaire will measure the frequency of community participation over a 7 days period. Each item is measured on a 5-point Likert scale, with 1=no participation in that activity and 5=7 days of participation in that activity. A total of 20 items are summed to yield a total score. Change in community participation will be calculated by subtracting baseline total score from the 3 month total score.	Baseline to 3 months

Collaborators and Investigators

• Sponsor: University of Haifa
• Investigators: Principal Investigator: Naor Domotor, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: STUDY21080031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No