Back to resultsiADAPT to Support Strategy Training After Stroke
Primary Purpose
Stroke, Adherence, Patient, Strategy Training
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strategy Training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Disability, Mobile Health Technology
Eligibility Criteria
Inclusion Criteria:
-Diagnosis of Stroke
Exclusion Criteria:
- prior exposure to Strategy Training
- vision impairment that impairs ability to read device screen or worksheet
- poor self-awareness (score of ≥2 on Self Awareness of Deficits Inventory item #1 or #2
- current major depressive, bipolar, or psychotic disorder (Patient Health Questionnaire-9, PRIME-MD)
- current alcohol or drug abuse (Mini International Neuropsychiatric Interview)
- severe aphasia (score ≤1 on Boston Diagnostic Aphasia Examination)
- current diagnosis of dementia, neurodegenerative disease, or cancer
- anticipated discharge to a skilled nursing facility
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Strategy Training: iADAPT Application
Strategy Training: Workbook
Arm Description
Participants will use the iADAPT mobile health application to supplement to in-person and remote intervention sessions.
Participants will use a printed workbook to supplement to in-person and remote (by telephone) intervention sessions.
Outcomes
Primary Outcome Measures
Adherence: Observed client behavior
Number of completed activity trials in the iADAPT application or Workbook
Adherence: Client-reported progress on goals.
Client rating of independence with self-selected goals (measured using Canadian Occupational Performance Measure)
Secondary Outcome Measures
Adherence: Client perspectives on treatment environment
Client rating on patient-provider connection and treatment expectancy measured by Healing Encounters and Attitudes Lists
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03253601
Brief Title
iADAPT to Support Strategy Training After Stroke
Official Title
iADAPT to Support Strategy Training After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
July 8, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adherence to rehabilitation interventions is associated with functional outcomes (e.g. independence in daily activities, return of motor function) after stroke. Low adherence to rehabilitation home programs is common after stroke. Interventions delivered via mobile health applications demonstrated positive effects on adherence to health behaviors (e.g. medication routines, smoking cessation). The investigators developed the iADAPT mobile application to support adherence to Strategy Training. Strategy Training is an iterative rehabilitation intervention the promotes goal setting, planning, and self-monitoring after stroke. This study examines the effects of the iADAPT mobile health application relative to a workbook on adherence to Strategy Training after stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Adherence, Patient, Strategy Training
Keywords
Rehabilitation, Disability, Mobile Health Technology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strategy Training: iADAPT Application
Arm Type
Experimental
Arm Description
Participants will use the iADAPT mobile health application to supplement to in-person and remote intervention sessions.
Arm Title
Strategy Training: Workbook
Arm Type
Active Comparator
Arm Description
Participants will use a printed workbook to supplement to in-person and remote (by telephone) intervention sessions.
Intervention Type
Behavioral
Intervention Name(s)
Strategy Training
Intervention Description
Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.
Primary Outcome Measure Information:
Title
Adherence: Observed client behavior
Description
Number of completed activity trials in the iADAPT application or Workbook
Time Frame
Baseline to 3 months
Title
Adherence: Client-reported progress on goals.
Description
Client rating of independence with self-selected goals (measured using Canadian Occupational Performance Measure)
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Adherence: Client perspectives on treatment environment
Description
Client rating on patient-provider connection and treatment expectancy measured by Healing Encounters and Attitudes Lists
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-Diagnosis of Stroke
Exclusion Criteria:
prior exposure to Strategy Training
vision impairment that impairs ability to read device screen or worksheet
poor self-awareness (score of ≥2 on Self Awareness of Deficits Inventory item #1 or #2
current major depressive, bipolar, or psychotic disorder (Patient Health Questionnaire-9, PRIME-MD)
current alcohol or drug abuse (Mini International Neuropsychiatric Interview)
severe aphasia (score ≤1 on Boston Diagnostic Aphasia Examination)
current diagnosis of dementia, neurodegenerative disease, or cancer
anticipated discharge to a skilled nursing facility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth R. Skidmore, PhD, OTR/L
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
15260
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
iADAPT to Support Strategy Training After Stroke
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