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

NCT ID: NCT05098730

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Strategy Training

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Strategy Training

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

Stroke survivors without pets

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Naor Demeter

Principal Investigator, Faculty Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naor Domotor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Naor Domotor, PhD

Role: CONTACT

NAD129@pitt.edu

4123836617

Elizabeth Skidmore, PhD

Role: CONTACT

skidmore@pitt.edu

4123836617

Facility Contacts

Minmei Shih, PhD, OTR/L

Role: primary

mis235@pitt.edu

412-383-6752

Elizabeth R Skidmore, PhD, OTR/L

Role: backup

skidmore@pitt.edu

(412) 383-6617

Other Identifiers

STUDY21080031

Identifier Type: -

Identifier Source: org_study_id