Cognitive TrainingNCT04615169
Multi-component Cognitive Intervention for Older Adults With Mixed Cognitive Abilities
A study testing Multi-component cognitive intervention with simulated everyday tasks (MCI-SET) in people with Cognitive Training and Dementia, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Objective: To assess the feasibility and preliminary effectiveness of an evidence-driven, pragmatic multi-component cognitive intervention with simulated everyday tasks (MCI-SET) with an inclusive group design in community centers Methods: One group, pre-test, post-test, and 3-month follow up research design. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Training, Dementia, Occupational Therapy
- What is being tested?
- Multi-component cognitive intervention with simulated everyday tasks (MCI-SET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 31 Dec 2018
- 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
Who may be able to join
- equal to or more than 65 years old, and frailty status according to the Study of Osteoporotic Fractures (SOF) criteria of frailty, or dependence with at least one daily activities.
Who cannot join
- People with non-cognitive issues, such as severe visual, hearing, or physical impairments, that interfered with completion of evaluations.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To assess the feasibility and preliminary effectiveness of an evidence-driven, pragmatic multi-component cognitive intervention with simulated everyday tasks (MCI-SET) with an inclusive group design in community centers Methods: One group, pre-test, post-test, and 3-month follow up research design. The participants who were >=65 and frail, dependence in >= one activity of daily living, or with a confirmed dementia from eight community centers. MCI-SET consisted 12 two-hour weekly group sessions. Feasibility was described with intervention development, fidelity, and acceptability. Outcomes included general daily functioning, general cognition, memory, attention, executive functioning, and processing speed.
Read the detailed description
According to the World Alzheimer Report 2018, 50 million people are living with dementia and the number is expected to triple to 152 million by 2050. Most people at high risk of dementia or with dementia reside in the community. Effective community-based programs can help to maintain functional levels and mitigate or prevent excessive functional decline. There are increasing empirical evidence to support structured and regular cognitive activities as part of brain health lifestyle .
Cognitive intervention is an increasing popular approach that aim to maintain or improve the cognitive functioning of the older adults with or without cognitive impairments. Appropriate cognitive intervention has the potential to change their brain neuro-mechanism. Recent evidence suggests that repeated practices of a carefully designed cognitive exercises with a high degree of similarity with real-life activities of daily living (ADL) (e.g., remembering the instructions for taking prescription medicine, identifying the medicine precautions, etc.) can improve both cognitive skills and cognitive functional performance.
Because of the complexity of cognitive issues people with cognitive impairments encounter, scholars have advocated for a multi-component cognitive intervention that includes more than one approach to make the best use of the individual approaches. The investigators conducted a quasi-experimental study that combined motor-cognitive dual-task exercises with high cognitive demands, cognitive training, and cognitive rehabilitation. The results showed that the intervention can improve cognitive skills and cognitive functional performance for people with mild cognitive impairments.
However, the need to strengthen the research design and to standardize treatment protocols led most cognitive intervention research to target a group of participants with similar cognitive skills, such as those with normal cognition, those with mild cognitive impairments, or those with dementia, etc. This homogeneity in participants is in sharp contrast to what is observed in communities, where most likely the group is inclusive of persons with different levels of cognitive skills. The efficacy of cognitive intervention with an inclusive group design was rarely examined.
Scholars have called for more effort to speed up the process of bridging evidence-based intervention to the everyday settings people live in. Cognitive intervention is in a situation of "leaky pipeline," that is, no systematic examination of how the evidence can be translated, tested in real-world settings (practice), and/or implemented across communities in the continuum of research evidence to widespread implementation. The increasing use of feasibility research design is mostly used as a precursor of randomized clinical trial, examining whether a study protocol requires adjustment, what the barriers and potential strategies are. With the abundance of research that supports the efficacy of cognitive intervention, to the best of the investigators' knowledge, there are no study that investigated the transportability of evidence-based cognitive intervention into the community.
This study discusses the feasibility, implementation, and preliminary effectiveness of an evidence-driven, multi-component cognitive intervention using simulated everyday tasks (MCI-SET) for cognitively-vulnerable older adults in community organizations in two cities in southern Taiwan.
- Conditions
- Cognitive Training, Dementia, Occupational Therapy, Aging, Long Term Care
- Being tested
- Multi-component cognitive intervention with simulated everyday tasks (MCI-SET)
- Keywords
- cognitive training, dementia prevention, Dementia, occupational therapy, community based practice, older people, long term care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component cognitive intervention with simulated everyday tasks (MCI-SET)Behavioural
2 hours per session: consisted primarily of modified everyday cognitive tasks, which were adjusted for individuals and for the group by the group leader to provide an error-reduction learning environment. Each session consisted of: (1) Warm-up: a 15-30 minute dual task of motor-cognitive exercises that increase arousal level and provide cognitive stimulation. For example, at the beginning of the group, the members would sing a song, mimic dance movement of the group leader, and clap hands when specific words occur in the song.
(2) 30-minutes guided and repetitive practices of contextually-relevant simulated everyday cognitive tasks with one 15 to 20- minute break in between; Cognitive tasks addressed complex attention, visual scanning, auditory attention, visual and motor memory, auditory memory, prospective memory, executive functioning, problem solving, etc.
| Study group | Role | What they receive |
|---|---|---|
| multi-component cognitive intervention using simulated everyday tasks (MCI-SET) | Experimental | the 12-week intervention, 2 hours weekly session of MCI-SET. Receives: Behavioral: Multi-component cognitive intervention with simulated everyday tasks (MCI-SET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kihon Checklist-Taiwan (KCL)
KCL is a self-reported questionnaire, consisted of 25 items (yes/no) divided into 7 sub-categories: general independence, physical strength, nutrition, oral function, level of social activities outside of home, cognitive function, and risk of depression. It takes about 15 minutes to complete. Each item is rated as pass (0) or fail (1). A higher total score indicates worse functioning. KCL has been used as a reliable indicator of daily functioning and progression of disability in Japan National Long-term Care. Taiwan Ministry of Health and Welfare adopted KCL-Taiwan version as an indicator of daily functioning for the use of national-wide disability prevention and delay community-based programs.
Measured: up to one month before the start of intervention
Kihon Checklist-Taiwan (KCL)
KCL is a self-reported questionnaire, consisted of 25 items (yes/no) divided into 7 sub-categories: general independence, physical strength, nutrition, oral function, level of social activities outside of home, cognitive function, and risk of depression. It takes about 15 minutes to complete. Each item is rated as pass (0) or fail (1). A higher total score indicates worse functioning. KCL has been used as a reliable indicator of daily functioning and progression of disability in Japan National Long-term Care. Taiwan Ministry of Health and Welfare adopted KCL-Taiwan version as an indicator of daily functioning for the use of national-wide disability prevention and delay community-based programs.
Measured: up to one month after the end of intervention
Kihon Checklist-Taiwan (KCL)
KCL is a self-reported questionnaire, consisted of 25 items (yes/no) divided into 7 sub-categories: general independence, physical strength, nutrition, oral function, level of social activities outside of home, cognitive function, and risk of depression. It takes about 15 minutes to complete. Each item is rated as pass (0) or fail (1). A higher total score indicates worse functioning. KCL has been used as a reliable indicator of daily functioning and progression of disability in Japan National Long-term Care. Taiwan Ministry of Health and Welfare adopted KCL-Taiwan version as an indicator of daily functioning for the use of national-wide disability prevention and delay community-based programs.
Measured: up to 4 months after the end of intervention
General Cognition
Montreal Cognitive Assessment-Taiwan version (MoCA-T). MoCA-T is in paper-and-pencil format and the maximal score is 30, with higher scores indicating better cognition. MoCA-T total score is adjusted for education effects.
Measured: up to one month before the start of intervention
General Cognition
Montreal Cognitive Assessment-Taiwan version (MoCA-T). MoCA-T is in paper-and-pencil format and the maximal score is 30, with higher scores indicating better cognition. MoCA-T total score is adjusted for education effects.
Measured: up to one month after the end of intervention
General Cognition
Montreal Cognitive Assessment-Taiwan version (MoCA-T). MoCA-T is in paper-and-pencil format and the maximal score is 30, with higher scores indicating better cognition. MoCA-T total score is adjusted for education effects.
Measured: up to 4 months after the end of intervention
Secondary outcomes (9)
Functional episodic memory
Functional episodic memory was assessed by using the event-based task in Miami Prospective Memory Test (MPMT). The participants were asked to pick up an envelope on the desk, get a fixed amount of paper bills from the envelope, give one bill to the examiner and put another one in another envelope when an alarm sounds in 30 minutes later. A total score ranges from 0-9 from three sub-scores of "intention to perform, accuracy, and need for reminders."
Measured: up to one month before the start of intervention
Functional episodic memory
Functional episodic memory was assessed by using the event-based task in Miami Prospective Memory Test (MPMT). The participants were asked to pick up an envelope on the desk, get a fixed amount of paper bills from the envelope, give one bill to the examiner and put another one in another envelope when an alarm sounds in 30 minutes later. A total score ranges from 0-9 from three sub-scores of "intention to perform, accuracy, and need for reminders."
Measured: up to one month after the end of intervention
Functional episodic memory
Functional episodic memory was assessed by using the event-based task in Miami Prospective Memory Test (MPMT). The participants were asked to pick up an envelope on the desk, get a fixed amount of paper bills from the envelope, give one bill to the examiner and put another one in another envelope when an alarm sounds in 30 minutes later. A total score ranges from 0-9 from three sub-scores of "intention to perform, accuracy, and need for reminders."
Measured: up to 4 months after the end of intervention
short-term memory and working memory
Wechsler Adult Intelligence Scale-IV Digit Span subtest (Digits Forward, DF, and Digits Backwards, DB) measure short-term memory (DF) and working memory (DB). Participants listened to a sequence of digits and were asked to recall the sequence correctly (DF) or in reverse-order (DB). Total scores ranged from 2-9 for DF and 2-8 for DB
Measured: up to one month before the start of intervention
short-term memory and working memory
Wechsler Adult Intelligence Scale-IV Digit Span subtest (Digits Forward, DF, and Digits Backwards, DB) measure short-term memory (DF) and working memory (DB). Participants listened to a sequence of digits and were asked to recall the sequence correctly (DF) or in reverse-order (DB). Total scores ranged from 2-9 for DF and 2-8 for DB
Measured: up to one month after the end of intervention
short-term memory and working memory
Wechsler Adult Intelligence Scale-IV Digit Span subtest (Digits Forward, DF, and Digits Backwards, DB) measure short-term memory (DF) and working memory (DB). Participants listened to a sequence of digits and were asked to recall the sequence correctly (DF) or in reverse-order (DB). Total scores ranged from 2-9 for DF and 2-8 for DB
Measured: up to 4 months after the end of intervention
Attention and executive Functioning
Attention and executive Functioning was measured by Color Trail Test Part 1 (CTT-1)(attention) and Part 2 (CTT-2) (executive function) (D'Elia, Satz, Uchiyama, \& White, 1996). Participants were asked to connect 25 numbered circles as quickly as possible. Their tests are timed in seconds. The shorter time indicates better performance.
Measured: up to one month before the start of intervention
Attention and executive Functioning
Attention and executive Functioning was measured by Color Trail Test Part 1 (CTT-1)(attention) and Part 2 (CTT-2) (executive function) (D'Elia, Satz, Uchiyama, \& White, 1996). Participants were asked to connect 25 numbered circles as quickly as possible. Their tests are timed in seconds. The shorter time indicates better performance.
Measured: up to one month after the end of intervention
Attention and executive Functioning
Attention and executive Functioning was measured by Color Trail Test Part 1 (CTT-1)(attention) and Part 2 (CTT-2) (executive function) (D'Elia, Satz, Uchiyama, \& White, 1996). Participants were asked to connect 25 numbered circles as quickly as possible. Their tests are timed in seconds. The shorter time indicates better performance.
Measured: up to 4 months after the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Aug 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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 Cognitive TrainingStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A multi-center one-group pretest, post-test, and 3-month follow up design
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Hui Chang, National Cheng Kung University
- Investigators
- Ling-Hui Chang, Ph.D, Study chair, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615169
- Sponsor's protocol ID
- National Cheng Kung University
- Status last verified
- Oct 2020
- First submitted
- 23 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mao HF, Tsai AY, Chang LH, Tsai IL. Multi-component cognitive intervention for older adults with mixed cognitive levels: implementation and preliminary effectiveness in real-world settings. BMC Geriatr. 2021 Oct 12;21(1):543. doi: 10.1186/s12877-021-02489-z.
PubMed 34641803
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-component Cognitive Intervention for Older Adults With Mixed Cognitive Abilities
- ClinicalTrials.gov ID
- NCT04615169
- Acronym / sponsor ID
- National Cheng Kung University
- Conditions
- Cognitive Training, Dementia, Occupational Therapy, Aging, Long Term Care
- Keywords
- cognitive training, dementia prevention, Dementia, occupational therapy, community based practice, older people, long term care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 4 Nov 2020 (actual)
- 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.
Objective: To assess the feasibility and preliminary effectiveness of an evidence-driven, pragmatic multi-component cognitive intervention with simulated everyday tasks (MCI-SET) with an inclusive group design in community centers Methods: One group, pre-test, post-test, and 3-month follow up research design. The participants who were >=65 and frail, dependence in >= one activity of daily living, or with a confirmed dementia from eight community centers. MCI-SET consisted 12 two-hour weekly group sessions. Feasibility was described with intervention development, fidelity, and acceptability. Outcomes included general daily functioning, general cognition, memory, attention, executive functioning, and processing speed.
Detailed description
According to the World Alzheimer Report 2018, 50 million people are living with dementia and the number is expected to triple to 152 million by 2050. Most people at high risk of dementia or with dementia reside in the community. Effective community-based programs can help to maintain functional levels and mitigate or prevent excessive functional decline. There are increasing empirical evidence to support structured and regular cognitive activities as part of brain health lifestyle .
Cognitive intervention is an increasing popular approach that aim to maintain or improve the cognitive functioning of the older adults with or without cognitive impairments. Appropriate cognitive intervention has the potential to change their brain neuro-mechanism. Recent evidence suggests that repeated practices of a carefully designed cognitive exercises with a high degree of similarity with real-life activities of daily living (ADL) (e.g., remembering the instructions for taking prescription medicine, identifying the medicine precautions, etc.) can improve both cognitive skills and cognitive functional performance.
Because of the complexity of cognitive issues people with cognitive impairments encounter, scholars have advocated for a multi-component cognitive intervention that includes more than one approach to make the best use of the individual approaches. The investigators conducted a quasi-experimental study that combined motor-cognitive dual-task exercises with high cognitive demands, cognitive training, and cognitive rehabilitation. The results showed that the intervention can improve cognitive skills and cognitive functional performance for people with mild cognitive impairments.
However, the need to strengthen the research design and to standardize treatment protocols led most cognitive intervention research to target a group of participants with similar cognitive skills, such as those with normal cognition, those with mild cognitive impairments, or those with dementia, etc. This homogeneity in participants is in sharp contrast to what is observed in communities, where most likely the group is inclusive of persons with different levels of cognitive skills. The efficacy of cognitive intervention with an inclusive group design was rarely examined.
Scholars have called for more effort to speed up the process of bridging evidence-based intervention to the everyday settings people live in. Cognitive intervention is in a situation of "leaky pipeline," that is, no systematic examination of how the evidence can be translated, tested in real-world settings (practice), and/or implemented across communities in the continuum of research evidence to widespread implementation. The increasing use of feasibility research design is mostly used as a precursor of randomized clinical trial, examining whether a study protocol requires adjustment, what the barriers and potential strategies are. With the abundance of research that supports the efficacy of cognitive intervention, to the best of the investigators' knowledge, there are no study that investigated the transportability of evidence-based cognitive intervention into the community.
This study discusses the feasibility, implementation, and preliminary effectiveness of an evidence-driven, multi-component cognitive intervention using simulated everyday tasks (MCI-SET) for cognitively-vulnerable older adults in community organizations in two cities in southern Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A multi-center one-group pretest, post-test, and 3-month follow up design
| Arm | Type | Receives |
|---|---|---|
| multi-component cognitive intervention using simulated everyday tasks (MCI-SET) | Experimental | Behavioral: Multi-component cognitive intervention with simulated everyday tasks (MCI-SET)the 12-week intervention, 2 hours weekly session of MCI-SET. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- equal to or more than 65 years old, and frailty status according to the Study of Osteoporotic Fractures (SOF) criteria of frailty, or dependence with at least one daily activities.
Key exclusion criteria (1 listed)
- People with non-cognitive issues, such as severe visual, hearing, or physical impairments, that interfered with completion of evaluations.
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 |
|---|---|---|
| Multi-component cognitive intervention with simulated everyday tasks (MCI-SET)2 hours per session: consisted primarily of modified everyday cognitive tasks, which were adjusted for individuals and for the group by the group leader to provide an error-reduction learning environment. Each session consisted of: (1) Warm-up: a 15-30 minute dual task of motor-cognitive exercises that increase arousal level and provide cognitive stimulation. For example, at the beginning of the group, the members would sing a song, mimic dance movement of the group leader, and clap hands when specific words occur in the song. (2) 30-minutes guided and repetitive practices of contextually-relevant simulated everyday cognitive tasks with one 15 to 20- minute break in between; Cognitive tasks addressed complex attention, visual scanning, auditory attention, visual and motor memory, auditory memory, prospective memory, executive functioning, problem solving, etc. | Behavioural | multi-component cognitive intervention using simulated everyday tasks (MCI-SET) |
Primary outcome
Kihon Checklist-Taiwan (KCL)
Time frame: up to one month before the start of intervention
KCL is a self-reported questionnaire, consisted of 25 items (yes/no) divided into 7 sub-categories: general independence, physical strength, nutrition, oral function, level of social activities outside of home, cognitive function, and risk of depression. It takes about 15 minutes to complete. Each item is rated as pass (0) or fail (1). A higher total score indicates worse functioning. KCL has been used as a reliable indicator of daily functioning and progression of disability in Japan National Long-term Care. Taiwan Ministry of Health and Welfare adopted KCL-Taiwan version as an indicator of daily functioning for the use of national-wide disability prevention and delay community-based programs.
Kihon Checklist-Taiwan (KCL)
Time frame: up to one month after the end of intervention
KCL is a self-reported questionnaire, consisted of 25 items (yes/no) divided into 7 sub-categories: general independence, physical strength, nutrition, oral function, level of social activities outside of home, cognitive function, and risk of depression. It takes about 15 minutes to complete. Each item is rated as pass (0) or fail (1). A higher total score indicates worse functioning. KCL has been used as a reliable indicator of daily functioning and progression of disability in Japan National Long-term Care. Taiwan Ministry of Health and Welfare adopted KCL-Taiwan version as an indicator of daily functioning for the use of national-wide disability prevention and delay community-based programs.
Kihon Checklist-Taiwan (KCL)
Time frame: up to 4 months after the end of intervention
KCL is a self-reported questionnaire, consisted of 25 items (yes/no) divided into 7 sub-categories: general independence, physical strength, nutrition, oral function, level of social activities outside of home, cognitive function, and risk of depression. It takes about 15 minutes to complete. Each item is rated as pass (0) or fail (1). A higher total score indicates worse functioning. KCL has been used as a reliable indicator of daily functioning and progression of disability in Japan National Long-term Care. Taiwan Ministry of Health and Welfare adopted KCL-Taiwan version as an indicator of daily functioning for the use of national-wide disability prevention and delay community-based programs.
General Cognition
Time frame: up to one month before the start of intervention
Montreal Cognitive Assessment-Taiwan version (MoCA-T). MoCA-T is in paper-and-pencil format and the maximal score is 30, with higher scores indicating better cognition. MoCA-T total score is adjusted for education effects.
General Cognition
Time frame: up to one month after the end of intervention
Montreal Cognitive Assessment-Taiwan version (MoCA-T). MoCA-T is in paper-and-pencil format and the maximal score is 30, with higher scores indicating better cognition. MoCA-T total score is adjusted for education effects.
General Cognition
Time frame: up to 4 months after the end of intervention
Montreal Cognitive Assessment-Taiwan version (MoCA-T). MoCA-T is in paper-and-pencil format and the maximal score is 30, with higher scores indicating better cognition. MoCA-T total score is adjusted for education effects.
9 secondary outcomes
Functional episodic memory
Time frame: up to one month before the start of intervention
Functional episodic memory
Time frame: up to one month after the end of intervention
Functional episodic memory
Time frame: up to 4 months after the end of intervention
short-term memory and working memory
Time frame: up to one month before the start of intervention
short-term memory and working memory
Time frame: up to one month after the end of intervention
short-term memory and working memory
Time frame: up to 4 months after the end of intervention
Attention and executive Functioning
Time frame: up to one month before the start of intervention
Attention and executive Functioning
Time frame: up to one month after the end of intervention
Attention and executive Functioning
Time frame: up to 4 months after the end of 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 4 Nov 2020.
- Derived from this study: PubMed 34641803Mao HF, Tsai AY, Chang LH, Tsai IL. Multi-component cognitive intervention for older adults with mixed cognitive levels: implementation and preliminary effectiveness in real-world settings. BMC Geriatr. 2021 Oct 12;21(1):543. doi: 10.1186/s12877-021-02489-z.
- Individual participant dataSharing planned: No
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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.
Ling-Hui Chang, Ph.D study chair
National Cheng Kung 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 Multi-component cognitive intervention with simulated everyday tasks (MCI-SET) in people with Cognitive Training and Dementia, run by National Cheng Kung University 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 1 inclusion and 1 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 4 Nov 2020. 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?
Kihon Checklist-Taiwan (KCL) (time frame: up to one month before the start of intervention). The study lists 6 primary outcomes in all. 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 NCT04615169, 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 4 Nov 2020.