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CompletedNCT03253601Updated Jul 2, 2020

iADAPT to Support Strategy Training After Stroke

An interventional study of Strategy Training in Stroke, Adherence, Patient and Strategy Training, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 105 Years. Per ClinicalTrials.gov, last updated 2020-07-02.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 105 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke
  • Adherence, Patient
  • Strategy Training

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Keywords

  • Rehabilitation
  • Disability
  • Mobile Health Technology
03

Who can participate

Ages eligible
18 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

-Diagnosis of Stroke

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralStrategy 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.

05

What researchers measure

Primary outcomes

  1. Adherence: Observed client behavior

    Number of completed activity trials in the iADAPT application or Workbook

    Time frame: Baseline to 3 months

  2. Adherence: Client-reported progress on goals.

    Client rating of independence with self-selected goals (measured using Canadian Occupational Performance Measure)

    Time frame: Baseline and 3 months

Secondary outcomes

  1. Adherence: Client perspectives on treatment environment

    Client rating on patient-provider connection and treatment expectancy measured by Healing Encounters and Attitudes Lists

    Time frame: Baseline and 3 months

06

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15260, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03253601
Lead sponsor
University of Pittsburgh
Responsible party
Elizabeth R. Skidmore, PhD, OTR/L (Professor, University of Pittsburgh) — Principal investigator
First posted
Aug 18, 2017
Start date
Aug 14, 2017
Primary completion
Jul 8, 2019
Completion
Dec 31, 2019
Last update
Jul 2, 2020

Study contacts

Elizabeth R. Skidmore, PhD, OTR/L
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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