search
Back to results

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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strategy Training
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of PittsburghRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stroke survivors with pets

Stroke survivors without pets

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 15, 2021
Last Updated
March 7, 2022
Sponsor
University of Pittsburgh
search

1. Study Identification

Unique Protocol Identification Number
NCT05098730
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stroke survivors with pets
Arm Type
Experimental
Arm Description
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.
Arm Title
Stroke survivors without pets
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strategy Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean engagement score as measured by the Pittsburgh Rehabilitation Participation Scale
Description
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.
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Change in attention as measured by the Color Trail Test 1
Description
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.
Time Frame
Baseline to 3 months
Title
Change in executive function as measured by the Color Trail Test 2
Description
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.
Time Frame
Baseline to 3 months
Title
Change in community participation as measure by Community Participation Indicators score
Description
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.
Time Frame
Baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Stroke survivors with pets Inclusion Criteria: 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 Exclusion Criteria: 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 Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naor Domotor, PhD
Phone
4123836617
Email
NAD129@pitt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Skidmore, PhD
Phone
4123836617
Email
skidmore@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naor Domotor, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minmei Shih, PhD, OTR/L
Phone
412-383-6752
Email
mis235@pitt.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth R Skidmore, PhD, OTR/L
Phone
(412) 383-6617
Email
skidmore@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs