iADAPT to Support Strategy Training After Stroke

NCT03253601 | Completed

• 1 other identifier: PRO17030372
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Adherence, Patient; Strategy Training

Keywords

Rehabilitation; Disability; Mobile Health Technology

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adherence: Client perspectives on treatment environment

  Baseline and 3 months

Study Arms (2)

Strategy Training: iADAPT Application

EXPERIMENTAL

Participants will use the iADAPT mobile health application to supplement to in-person and remote intervention sessions.

Behavioral: Strategy Training

Strategy Training: Workbook

ACTIVE COMPARATOR

Participants will use a printed workbook to supplement to in-person and remote (by telephone) intervention sessions.

Behavioral: Strategy Training

Interventions

Strategy Training BEHAVIORAL

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.

Strategy Training: Workbook; Strategy Training: iADAPT Application

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Stroke

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Stroke; Patient Compliance

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Elizabeth R. Skidmore, PhD, OTR/L

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 18, 2017
• Study Start: August 14, 2017
• Primary Completion: July 8, 2019
• Study Completion: December 31, 2019
• Last Updated: July 2, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)