iADAPT to Support Strategy Training After Stroke

Stroke Clinical Trial

Official title:

iADAPT to Support Strategy Training After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253601
• Other study ID #: PRO17030372
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 31, 2019
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient
• Strategy Training
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence: Observed client behavior	Number of completed activity trials in the iADAPT application or Workbook	Baseline to 3 months
Primary	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	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