iADAPT to Support Strategy Training After Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Adherence, Patient; Strategy Training
• Intervention / Treatment: Behavioral: Strategy Training

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strategy Training: iADAPT Application; Participants will use the iADAPT mobile health application to supplement to in-person and remote intervention sessions.	Behavioral: Strategy Training; 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.
Active Comparator: Strategy Training: Workbook; Participants will use a printed workbook to supplement to in-person and remote (by telephone) intervention sessions.	Behavioral: Strategy Training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence: Observed client behavior	Number of completed activity trials in the iADAPT application or Workbook	Baseline to 3 months
Adherence: Client-reported progress on goals.	Client rating of independence with self-selected goals (measured using Canadian Occupational Performance Measure)	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence: Client perspectives on treatment environment	Client rating on patient-provider connection and treatment expectancy measured by Healing Encounters and Attitudes Lists	Baseline and 3 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Elizabeth R. Skidmore, PhD, OTR/L, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): July 8, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Disability; Mobile Health Technology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PRO17030372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No