Alzheimer's DiseaseNCT02005380
Usability Study of Spaced Retrieval Exercise Using Mobile Devices for Alzheimer's Disease Rehabilitation
An observational study of Alzheimer's Disease, run by German-Jordanian University at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Text-based task and Graphic-based Task
- How many people
- 20 participants
- Where
- 1 siteJordan
- Study dates
- Nov 2013to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Darat Samir Shamma, a senior residential care facility and
Who may be able to join
- Have early stages of Alzheimer's decease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Text-based task, Graphic-based Task
- Keywords
- Alzheimer's Disease Rehabilitation
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text-based taskOther
Participants are required to take text-based exercise.
Graphic-based TaskOther
Participants are required to take the graphic-based exercise.
| Study group | Role | What they receive |
|---|---|---|
| Text-based Task | This group is required to do the text-based task Receives: Other: Text-based task | |
| Graphic-based Task | This group is required to do the graphic-based task Receives: Other: Graphic-based Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (1)
Test Score
Test score measures the percentage of questions answered by the participants correctly from the first trial.
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- German-Jordanian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Zmily, German-Jordanian University
- Investigators
- Ahmad Zmily, PhD, Principal investigator, German-Jordanian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005380
- Sponsor's protocol ID
- GJU001
- Status last verified
- Dec 2013
- First submitted
- 29 Nov 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Study of Spaced Retrieval Exercise Using Mobile Devices for Alzheimer's Disease Rehabilitation
- ClinicalTrials.gov ID
- NCT02005380
- Acronym / sponsor ID
- GJU001
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- German-Jordanian UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text-based Task | – | Other: Text-based taskThis group is required to do the text-based task |
| Graphic-based Task | – | Other: Graphic-based TaskThis group is required to do the graphic-based task |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Darat Samir Shamma, a senior residential care facility and
Key inclusion criteria (1 listed)
- Have early stages of Alzheimer's decease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text-based taskParticipants are required to take text-based exercise. | Other | Text-based Task |
| Graphic-based TaskParticipants are required to take the graphic-based exercise. | Other | Graphic-based Task |
Primary outcome
NASA Task Load Index Measure
Time frame: 1 hour
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 secondary outcome
Test Score
Time frame: 1 Hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Zmily, PhD principal investigator
German-Jordanian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by German-Jordanian University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NASA Task Load Index Measure (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2013.