Usability Study of Spaced Retrieval Exercise Using Mobile... | NCT02005380

Studies
Usability Study of Spaced Retrieval Exercise Using Mobile Devices for Alzheimer's Disease Rehabilitation

NCT02005380

Sponsor

German-Jordanian University

Status

Completed

Last Update Posted

Dec 9, 2013Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Alzheimer's Disease

Interventions

Text-based task
Graphic-based Task

Countries

Jordan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Nov 29, 2013

First Submission Date that Met QC Criteria

Dec 6, 2013

First Posted Date

Dec 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2013

Last Update Posted Date

Dec 9, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The focus of this work is to explore the use of modern mobile technology to enable people with Alzheimer's disease to improve their abilities to perform activities of daily living and hence to promote independence and participation in social activities. This work also aims at reducing the burden on caregivers by increasing the AD patients' sense of competence and ability to handle behavior problems.

Detailed Description

The investigators developed ADcope, an integrated application that includes several modules that target individuals with Alzheimer's disease , using mobile devices. The investigators developed two different user interfaces: a text-based and a graphic-based. To evaluate the usability of the application, participants with early stages of AD were asked to run the two user interfaces of the spaced retrieval memory exercise using a tablet mobile device.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Text-based Task		This group is required to do the text-based task	Other: Text-based task
Graphic-based Task		This group is required to do the graphic-based task	Other: Graphic-based Task

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Text-based task	Other	Participants are required to take text-based exercise.	Text-based Task

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NASA Task Load Index Measure	NASA-TLX is a multi-dimensional rating procedure that derives an overall workload score based on a weighted average of ratings on six subscales. These subscales include Mental Demands, Physical Demands, Temporal Demands, Own Performance, Effort, and Frustration.	1 hour

Secondary Outcomes

Measure	Description	Time Frame
Test Score	Test score measures the percentage of questions answered by the participants correctly from the first trial.	1 Hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Have early stages of Alzheimer's decease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Darat Samir Shamma, a senior residential care facility and

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmad Zmily, PhD	German-Jordanian University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Darat Samir Shamma		Amman	Amman Governorate	11934	Jordan

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided