DementiaNCT02671630
Computerized Cognitive Training Program for Older Persons With Mild Dementia
A study testing A community-based computerized cognitive training program in people with Dementia, run by Far Eastern Memorial Hospital.
Trial summary
Little is known about the effects of computerized cognitive training programs on mild dementia patients' health. The purpose of this study was to examine the effects of a community-based computerized cognitive training program. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- A community-based computerized cognitive training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Oct 2013
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Patients' Inclusion Criteria:
- Aged 65 or older,
- Being diagnosed as having mild dementia by a neurologist, and
- Being able to communicate in Mandarin or Taiwanese.
Patients' Exclusion Criteria:
- Vision or hearing impairment.
Caregivers' (proxy) Inclusion Criteria:
- Living with the dementia patient,
- The family member spending the most time on the patient's care, and
- >20 years old.
Caregivers' (proxy) Exclusion Criteria:
- Terminally ill
About this study
Little is known about the effects of computerized cognitive training programs on mild dementia patients' health. The purpose of this study was to examine the effects of a community-based computerized cognitive training program.
Read the detailed description
Little is known about the effects of computerized cognitive training programs on mild dementia patients' health. The purpose of this study was to examine the effects of a community-based computerized cognitive training program.However, most of these studies were not randomized controlled trial and the samples of these studies were mostly healthy older persons, patients with brain injuries, or with moderate and severe dementia. A lack of studies for effects of these programs on patients with mild dementia using randomized controlled trials was found. The purpose of this study was to examine the effects of a community-based computerized cognitive training program.
- Conditions
- Dementia
- Being tested
- A community-based computerized cognitive training program
- Keywords
- Cognitive function, Depression, Quality of life, Community-based computerized cognitive training program, Randomized controlled trial
- Medical subject headings
- Dementia, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A community-based computerized cognitive training programOther
The computer training games included: 1) a phonological loop to train the participants to choose correct song from a list of different songs which can be categorized as people, nature, and musical instrument. The difficulty level progressed from choosing one from two to choosing one from three songs; 2) a visual-spatial sketchpad to train the participants to remember and find the same graphs including vegetable, fruits, daily necessity, and numbers. The difficulty level progressed from finding one pair to three pairs of similar graphs; 3) a central executive system to train the participants to execute dual tasks including conducting dual memory, calculating while listening to music, making phone calls, and matching medication at correct time.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients receive only usual hospital care |
| Experimental group | Experimental | Patients receive only usual hospital care and community-based computerized cognitive training program Receives: Other: A community-based computerized cognitive training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Abilities as assessed by Cognitive Abilities Screening Instrument.
Measured: 3 months
Memory as assessed by Prospective and Retrospective Memory Questionnaire.
Measured: 3 months
Cognitive State as assessed by Mini-Mental State Examination
Measured: 3 months
Secondary outcomes (2)
Depression as assessed by Geriatric Depression Scale.
Measured: 3 months
Quality of Life as assessed by Chinese Dementia Quality of Life, DQoL.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJun 2013
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yam-Ting Kwok, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671630
- Sponsor's protocol ID
- NSC 101-2314-B-570-001
- Status last verified
- Jan 2016
- First submitted
- 23 Jan 2016
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Training Program for Older Persons With Mild Dementia
- ClinicalTrials.gov ID
- NCT02671630
- Acronym / sponsor ID
- NSC 101-2314-B-570-001
- Conditions
- Dementia
- Keywords
- Cognitive function, Depression, Quality of life, Community-based computerized cognitive training program, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2013 (actual)
- First posted
- 2 Feb 2016 (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.
Little is known about the effects of computerized cognitive training programs on mild dementia patients' health. The purpose of this study was to examine the effects of a community-based computerized cognitive training program.
Detailed description
Little is known about the effects of computerized cognitive training programs on mild dementia patients' health. The purpose of this study was to examine the effects of a community-based computerized cognitive training program.However, most of these studies were not randomized controlled trial and the samples of these studies were mostly healthy older persons, patients with brain injuries, or with moderate and severe dementia. A lack of studies for effects of these programs on patients with mild dementia using randomized controlled trials was found. The purpose of this study was to examine the effects of a community-based computerized cognitive training program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients receive only usual hospital care |
| Experimental group | Experimental | Other: A community-based computerized cognitive training programPatients receive only usual hospital care and community-based computerized cognitive training program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| A community-based computerized cognitive training programThe computer training games included: 1) a phonological loop to train the participants to choose correct song from a list of different songs which can be categorized as people, nature, and musical instrument. The difficulty level progressed from choosing one from two to choosing one from three songs; 2) a visual-spatial sketchpad to train the participants to remember and find the same graphs including vegetable, fruits, daily necessity, and numbers. The difficulty level progressed from finding one pair to three pairs of similar graphs; 3) a central executive system to train the participants to execute dual tasks including conducting dual memory, calculating while listening to music, making phone calls, and matching medication at correct time. | Other | Experimental group |
Primary outcome
Cognitive Abilities as assessed by Cognitive Abilities Screening Instrument.
Time frame: 3 months
Memory as assessed by Prospective and Retrospective Memory Questionnaire.
Time frame: 3 months
Cognitive State as assessed by Mini-Mental State Examination
Time frame: 3 months
2 secondary outcomes
Depression as assessed by Geriatric Depression Scale.
Time frame: 3 months
Quality of Life as assessed by Chinese Dementia Quality of Life, DQoL.
Time frame: 3 months
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 2 Feb 2016.
Related trials for Dementia
Not yet recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-08161842 Are Tolerated and Act in the Body in Healthy and Older Adults
Alzheimer Disease
Active, not recruiting
Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise
Caregiver Resilience and Stress
Active, not recruitingObservational study
A Community-Based Screening Program to Identify Participants at High Risk for Amyloid Pathology
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
RecruitingObservational study
Triage Survey for Neurology Research Eligibility
Alzheimer Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing A community-based computerized cognitive training program in people with Dementia, run by Far Eastern Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Cognitive Abilities as assessed by Cognitive Abilities Screening Instrument. (time frame: 3 months). The study lists 3 primary outcomes in all. 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 2 Feb 2016.