Mild Cognitive ImpairmentNCT02462135
Protocol of Virtual Interactive Memory-Training Program
A study testing Virtual interactive memory training and Passive information activities in people with Mild Cognitive Impairment, run by Ministry of Science and Technology, Taiwan at 1 site in Taiwan.
Trial summary
This study sought to investigate the changes in objective memory performance (including immediate recall and delayed recall), subjective memory complaints and degree of depression in older adults with mild cognitive impairment after Virtual interactive memory training (VIMT). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Virtual interactive memory training and Passive information activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Dec 2017
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant
- Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms
- Clinical neurologic examination by the Mini-Mental State Examination (MMSE) score of 24 or higher, and cut-off score of 23/24 on the Montreal Cognitive Assessment (MoCA)
- No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family
Who cannot join
- The clinical diagnosis of dementia was based on the DSM-IV-TR
- Active in another cognitive or memory-related training in the past year
- Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment
- A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible
- Severe losses in vision, hearing, or communicative ability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development and Evaluation of the Effectiveness of a Virtual Interactive Memory Training Program for Older Adults With Mild Cognitive Impairment: Protocol of a Randomized Controlled Study
This study sought to investigate the changes in objective memory performance (including immediate recall and delayed recall), subjective memory complaints and degree of depression in older adults with mild cognitive impairment after Virtual interactive memory training (VIMT).
Read the detailed description
This double-blind randomized controlled study has a 2-arm parallel group design. All subjects will be randomized by the block randomization, into intervention group (Virtual interactive memory training, VIMT), or active control group (Passive information activities, PIA). Training sessions of the VIMT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as VIMT group. We constructed a rigorous VIMT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in memory function and degree of depression of older adults with mild cognitive impairment after using the VIMT.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Virtual interactive memory training, Passive information activities
- Keywords
- Mild cognitive impairment, Memory training, Randomized controlled study
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual interactive memory trainingBehavioural
Also called Memory training
Training sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each). The training content of the four memory training include: (1) spatial encoding memory training task, (2) updating-spatial memory training task, (3) updating-visual memory training task, and (4) rehearsal-visuospatial memory training task.
Passive information activitiesBehavioural
Also called Active control group
The active control group (Passive information activities) only accepts the initial training phase, which training content of the two types to include: (1) listening to audio books, and (2) reading online newspaper.
| Study group | Role | What they receive |
|---|---|---|
| Virtual interactive memory training | Experimental | Training sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each). Receives: Behavioral: Virtual interactive memory training |
| Passive information activities | Active comparator | The training of active control group is the same as VIMT group (45 min/day, 3 days/week, for 12 weeks, for a total of 36 sessions). The active control group receives only the initial training. Receives: Behavioral: Passive information activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in objective memory performance as measured by the Chinese version of the Wechsler Memory Scale-III (WMS-III).
Measured: Change from baseline in objective memory performance at Immediate post-test, 3 months, 6 months and one year after intervention.
Secondary outcomes (1)
Change in subjective memory complaints as measured by the Multifactorial Memory Questionnaire (MMQ).
Measured: Change from baseline in subjective memory complaints at Immediate post-test, 3 months, 6 months and one year after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startMar 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yang, Hui-Ling, Ministry of Science and Technology, Taiwan
- Investigators
- Hui-Ling Yang, PhD, Principal investigator, Taipei Medical UniversityKuei-Ru Chou, Professor, Study chair, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462135
- Sponsor's protocol ID
- 201301045
- Status last verified
- Dec 2017
- First submitted
- 28 May 2015
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang HL, Chu H, Kao CC, Chiu HL, Tseng IJ, Tseng P, Chou KR. Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. Age Ageing. 2019 Jul 1;48(4):519-525. doi: 10.1093/ageing/afz029.
PubMed 30989165
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of the Effectiveness of a Virtual Interactive Memory Training Program for Older Adults With Mild Cognitive Impairment: Protocol of a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02462135
- Acronym / sponsor ID
- 201301045
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild cognitive impairment, Memory training, Randomized controlled study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ministry of Science and Technology, TaiwanOther government
- Study start
- Mar 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Jun 2015 (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.
This study sought to investigate the changes in objective memory performance (including immediate recall and delayed recall), subjective memory complaints and degree of depression in older adults with mild cognitive impairment after Virtual interactive memory training (VIMT).
Detailed description
This double-blind randomized controlled study has a 2-arm parallel group design. All subjects will be randomized by the block randomization, into intervention group (Virtual interactive memory training, VIMT), or active control group (Passive information activities, PIA). Training sessions of the VIMT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as VIMT group. We constructed a rigorous VIMT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in memory function and degree of depression of older adults with mild cognitive impairment after using the VIMT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual interactive memory training | Experimental | Behavioral: Virtual interactive memory trainingTraining sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each). |
| Passive information activities | Active comparator | Behavioral: Passive information activitiesThe training of active control group is the same as VIMT group (45 min/day, 3 days/week, for 12 weeks, for a total of 36 sessions). The active control group receives only the initial training. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant
- Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms
- Clinical neurologic examination by the Mini-Mental State Examination (MMSE) score of 24 or higher, and cut-off score of 23/24 on the Montreal Cognitive Assessment (MoCA)
- No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family
Key exclusion criteria (5 listed)
- The clinical diagnosis of dementia was based on the DSM-IV-TR
- Active in another cognitive or memory-related training in the past year
- Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment
- A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible
- Severe losses in vision, hearing, or communicative ability
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 |
|---|---|---|
| Virtual interactive memory trainingAlso: Memory trainingTraining sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each). The training content of the four memory training include: (1) spatial encoding memory training task, (2) updating-spatial memory training task, (3) updating-visual memory training task, and (4) rehearsal-visuospatial memory training task. | Behavioural | Virtual interactive memory training |
| Passive information activitiesAlso: Active control groupThe active control group (Passive information activities) only accepts the initial training phase, which training content of the two types to include: (1) listening to audio books, and (2) reading online newspaper. | Behavioural | Passive information activities |
Primary outcome
Change in objective memory performance as measured by the Chinese version of the Wechsler Memory Scale-III (WMS-III).
Time frame: Change from baseline in objective memory performance at Immediate post-test, 3 months, 6 months and one year after intervention.
1 secondary outcome
Change in subjective memory complaints as measured by the Multifactorial Memory Questionnaire (MMQ).
Time frame: Change from baseline in subjective memory complaints at Immediate post-test, 3 months, 6 months and one year after intervention.
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 15 Dec 2017.
- Derived from this study: PubMed 30989165Yang HL, Chu H, Kao CC, Chiu HL, Tseng IJ, Tseng P, Chou KR. Development and effectiveness of virtual interactive working memory training for older people with mild cognitive impairment: a single-blind randomised controlled trial. Age Ageing. 2019 Jul 1;48(4):519-525. doi: 10.1093/ageing/afz029.
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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.
Hui-Ling Yang, PhD principal investigator
Taipei Medical University
Kuei-Ru Chou, Professor study chair
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual interactive memory training and Passive information activities in people with Mild Cognitive Impairment, run by Ministry of Science and Technology, Taiwan at 1 site in Taiwan.
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 4 inclusion and 5 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 15 Dec 2017. 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 Taiwan. 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?
Change in objective memory performance as measured by the Chinese version of the Wechsler Memory Scale-III (WMS-III). (time frame: Change from baseline in objective memory performance at Immediate post-test, 3 months, 6 months and one year after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02462135, which also lists 1 linked publication.
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 15 Dec 2017.