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

NCT05098730 | Not Yet Recruiting

• 1 other identifier: STUDY21080031
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in attention as measured by the Color Trail Test 1

  Baseline to 3 months

• Change in executive function as measured by the Color Trail Test 2

  Baseline to 3 months

• Change in community participation as measure by Community Participation Indicators score

  Baseline to 3 months

Study Arms (2)

Stroke survivors with pets

EXPERIMENTAL

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

Stroke survivors without pets

ACTIVE COMPARATOR

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

Interventions

Strategy Training BEHAVIORAL

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.

Stroke survivors with pets; Stroke survivors without pets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Dementia as indicated by Montreal Cognitive Assessment score of 18 or lower
• Severe aphasia as indicated by the Boston Diagnostic Aphasia Examination Severity Score of 0 or 1
• Self-report of a central nervous system disorder other than stroke
• Recent drug or alcohol addiction/abuse within 3 months prior to the Mini-Neuropsychiatric Interview
• Severe mental illness as indicated by the PRIME-MD
• Prior exposure to strategy training
• Currently participate in rehabilitation therapy programs
• Stroke survivors without pets
• Primary diagnosis of acute stroke
• At least 3 months after the stroke onset
• Living in a community residence
• Cognitive impairment as indicated by an Executive Interview score of 3 or higher
• Participation restrictions as indicated by an Activity Card Sort (\<80% of pre-stroke activities)
• Willing to participate in a 6-week program with 2 intervention sessions per week at home
• Dementia as indicated by Montreal Cognitive Assessment score of 18 or lower

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Naor Domotor, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naor Domotor, PhD

CONTACT

4123836617; NAD129@pitt.edu

Elizabeth Skidmore, PhD

CONTACT

4123836617; skidmore@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Faculty Associate

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 28, 2021
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)