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

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05098730
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.8
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: Strategy Training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Strategy Training and Pets to Promote Stroke Survivor's Cognitive Performance and Community Participation
• Actual Study Start Date: Jan 5, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Mean engagement score as measured by the Pittsburgh Rehabilitation Participation Scale [Baseline to 6 weeks]

   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.

Secondary Outcome Measures

1. Change in attention as measured by the Color Trail Test 1 [Baseline to 3 months]

   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.

2. Change in executive function as measured by the Color Trail Test 2 [Baseline to 3 months]

   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.

3. Change in community participation as measure by Community Participation Indicators score [Baseline to 3 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15219

Sponsors and Collaborators

• University of Pittsburgh

Investigators

• Principal Investigator: Naor Domotor, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Naor Domotor, Principal Investigator, Postdoctoral Associate, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT05098730
• Other Study ID Numbers: STUDY21080031
• First Posted: Oct 28, 2021
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Mar 22, 2022