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iPad Application-based Intervention for Post-stroke Depression

Primary Purpose

Post-stroke Depression

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
iPad Application + Usual Rehabilitation
Usual rehabilitation
Sponsored by
Kibi International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Depression

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 40 years and older
  • Males and females
  • Center for Epidemiologic Studies Depression Scale score ≥16
  • Mini Mental State Examination score ≥ 24
  • First stroke
  • Native language is Japanese
  • Written informed consent prior to participation

Exclusion Criteria:

  • Major depressive disorder before onset of stroke
  • Bilateral hemiplegia
  • Vision or hearing deficits that negatively impact everyday life
  • Severe aphasia
  • Severe unilateral spatial neglect
  • Diagnosis of neurodegenerative disease such as Parkinson's disease or multiple system atrophy
  • Current life-threatening severe organ failure, musculoskeletal disorders, or cancer

Sites / Locations

  • Kurashiki Heisei HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iPad Application + Usual Rehabilitation

Usual rehabilitation

Arm Description

The experimental group receives usual rehabilitation. In addition, participants watch a video using the iPad Application displaying positive word stimuli.

The control group receives usual rehabilitation.

Outcomes

Primary Outcome Measures

Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.

Secondary Outcome Measures

Health-related quality of life as measured by the 36-item short-form Medical Outcome Study Questionnaire (SF-36).
Activities of daily living as measured by Functional Independence Measure (FIM).
Dynamic standing balance as measured by Functional Reach Test (FRT).
Safety is defined as the proportion of patients who experience an intervention-related adverse event or any adverse event during the study.
Adverse events, whether or not considered causally related to the study intervention, include death and life-threatening illness or injury requiring prolonged hospitalization or resulting in persistent disability.

Full Information

First Posted
March 2, 2019
Last Updated
August 31, 2020
Sponsor
Kibi International University
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1. Study Identification

Unique Protocol Identification Number
NCT03864484
Brief Title
iPad Application-based Intervention for Post-stroke Depression
Official Title
An iPad Application-based Intervention for Improving Post-stroke Depression Symptoms: A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kibi International University

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
We plan to conduct a randomized controlled trial to examine whether usual rehabilitation plus an iPad application-based intervention improves post-stroke depression symptoms compared to usual rehabilitation alone. The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iPad Application + Usual Rehabilitation
Arm Type
Experimental
Arm Description
The experimental group receives usual rehabilitation. In addition, participants watch a video using the iPad Application displaying positive word stimuli.
Arm Title
Usual rehabilitation
Arm Type
Active Comparator
Arm Description
The control group receives usual rehabilitation.
Intervention Type
Device
Intervention Name(s)
iPad Application + Usual Rehabilitation
Intervention Description
The experimental group receives usual rehabilitation. In addition, the experimental group will watch movies using the iPad application for 3 minutes, once daily for 5 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Usual rehabilitation
Intervention Description
The control group receives usual rehabilitation.
Primary Outcome Measure Information:
Title
Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
Time Frame
Change from Baseline CES-D at 5 weeks
Secondary Outcome Measure Information:
Title
Health-related quality of life as measured by the 36-item short-form Medical Outcome Study Questionnaire (SF-36).
Time Frame
Change from Baseline SF-36 at 5 weeks
Title
Activities of daily living as measured by Functional Independence Measure (FIM).
Time Frame
Change from Baseline FIM at 5 weeks
Title
Dynamic standing balance as measured by Functional Reach Test (FRT).
Time Frame
Change from Baseline FRT at 5 weeks
Title
Safety is defined as the proportion of patients who experience an intervention-related adverse event or any adverse event during the study.
Description
Adverse events, whether or not considered causally related to the study intervention, include death and life-threatening illness or injury requiring prolonged hospitalization or resulting in persistent disability.
Time Frame
The period from the start of the intervention to 5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 40 years and older Males and females Center for Epidemiologic Studies Depression Scale score ≥16 Mini Mental State Examination score ≥ 24 First stroke Native language is Japanese Written informed consent prior to participation Exclusion Criteria: Major depressive disorder before onset of stroke Bilateral hemiplegia Vision or hearing deficits that negatively impact everyday life Severe aphasia Severe unilateral spatial neglect Diagnosis of neurodegenerative disease such as Parkinson's disease or multiple system atrophy Current life-threatening severe organ failure, musculoskeletal disorders, or cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hiroyuki Uchida
Phone
+81-86-427-1111
Email
hiroyukiuchida02@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuki Hirao, PhD
Organizational Affiliation
Kibi International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kurashiki Heisei Hospital
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-0826
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroyuki Uchida
Phone
+81-86-427-1111
Email
hiroyukiuchida02@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34456565
Citation
Ejiri H, Uchida H, Tsuchiya K, Fujiwara K, Kikuchi S, Hirao K. Effects of Smartphone-Delivered Positive-Word Stimulation on Depressed Mood in People with Subthreshold Depression: Protocol for a Pilot Randomized Controlled Trial. Neuropsychiatr Dis Treat. 2021 Aug 20;17:2739-2748. doi: 10.2147/NDT.S323126. eCollection 2021. Erratum In: Neuropsychiatr Dis Treat. 2021 Aug 30;17:2847-2848.
Results Reference
derived

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iPad Application-based Intervention for Post-stroke Depression

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