Subjective Cognitive ComplaintsNCT03612167
Constructing A Model of Health Promotion and Active Aging for Community-Dwelling Older Adults
A study testing cognitive intervention and nutritional group in people with Subjective Cognitive Complaints, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Cognitive intervention for people with subjective cognitive complaints can be categorized into cognitive training, cognitive rehabilitation, psychoeducation, lifestyle intervention, etc. Literature have suggested multicomponent cognitive interventions can have better outcomes. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Complaints
- What is being tested?
- cognitive intervention and nutritional group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2013to 1 Aug 2022
- 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
- Subjective cognition complaint by the client or caregiver: In our study, participants reported more than one complaint in Everyday Memory Questionnaire and Cognitive Function Questionnaire will be included.
- Objective cognition deficits: participants with scores under 1.5 Standard Deviation in Trail making test, Contextual memory test and Rivermead Behavior Memory Test-3rd edition were included.
- Preserved most daily living function: participants have reported no Activity of Daily Living (ADL) difficulties.
Who cannot join
- A confirmed diagnosis of dementia
- With visual and auditory impairments, and other neurocognitive disease that can potential influence participation in group activities, including stroke, Parkinson's disease and traumatic brain injury, major depression, and substance abuse.
- With Mini Mental Status Exam <=24 (education status beyond primary school); or <=16 (No education)
- With less than 10-session participation rate out of 12.
Trial locations and contacts
1 site in 1 country.
About this study
Cognitive intervention for people with subjective cognitive complaints can be categorized into cognitive training, cognitive rehabilitation, psychoeducation, lifestyle intervention, etc. Literature have suggested multicomponent cognitive interventions can have better outcomes. However, studies to support this proposition are still limited. Few studies have also examined the influences of cognitive intervention on functional performance. This study was to examine the effectiveness of a multicomponent cognitive intervention for community-dwelling elderly with subjective cognitive complaints.
- Conditions
- Subjective Cognitive Complaints
- Being tested
- cognitive intervention, nutritional group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive interventionBehavioural
a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives.
nutritional groupBehavioural
12 consecutive 90-minute weekly nutritional groups that included nutrition classes (lecture and discussion).
| Study group | Role | What they receive |
|---|---|---|
| multi-modal cognitive intervention | Experimental | a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives. Receives: Behavioral: cognitive intervention |
| nutritional group | Active comparator | A quasi-experimental design with nonequivalent control was adopted in a senior center. The intervention for control group was a 12 consecutive 90-minute weekly nutritional groups that included nutrition classes (lecture and discussion). Receives: Behavioral: nutritional group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mini-Mental State Examination
cognition
Measured: 3 month
the Trail Making Test
attention
Measured: 3 month
the Color Trail Test
attention
Measured: 3 month
Rivermead Behavioral Memory Test
memory
Measured: 3 month
the Contextual Memory Test
memory
Measured: 3 month
the Digit Span test
memory
Measured: 3 month
Secondary outcomes (2)
Cognitive Failure Questionnaire and the
perceived cognitive failures
Measured: 3 month
Everyday Memory Questionnaire
perceived memory problems
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 Mar 2013
- Primary completion1 Aug 2020
- Study completion1 Aug 2022 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive ComplaintsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A quasi-experimental design with nonequivalent control was adopted in a senior center. Experimental variable was a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives. Participants were allocated into intervention group (cognitive intervention group) and control group (nutrition education group). The group assignment depended on what group they signed up for participate.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University of Science and Technology
- Responsible party
- Principal investigator, Ling-Hui Chang, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612167
- Sponsor's protocol ID
- 102-2717B
- Status last verified
- Sep 2020
- First submitted
- 22 Jul 2018
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On-going research. Individual data will only share within the research team.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constructing A Model of Health Promotion and Active Aging for Community-Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT03612167
- Acronym / sponsor ID
- 102-2717B
- Conditions
- Subjective Cognitive Complaints
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: no funding
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Collaborators
- Chang Gung University of Science and Technology
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 2 Aug 2018 (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.
Cognitive intervention for people with subjective cognitive complaints can be categorized into cognitive training, cognitive rehabilitation, psychoeducation, lifestyle intervention, etc. Literature have suggested multicomponent cognitive interventions can have better outcomes. However, studies to support this proposition are still limited. Few studies have also examined the influences of cognitive intervention on functional performance. This study was to examine the effectiveness of a multicomponent cognitive intervention for community-dwelling elderly with subjective cognitive complaints.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A quasi-experimental design with nonequivalent control was adopted in a senior center. Experimental variable was a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives. Participants were allocated into intervention group (cognitive intervention group) and control group (nutrition education group). The group assignment depended on what group they signed up for participate.
| Arm | Type | Receives |
|---|---|---|
| multi-modal cognitive intervention | Experimental | Behavioral: cognitive interventiona 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives. |
| nutritional group | Active comparator | Behavioral: nutritional groupA quasi-experimental design with nonequivalent control was adopted in a senior center. The intervention for control group was a 12 consecutive 90-minute weekly nutritional groups that included nutrition classes (lecture and discussion). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Subjective cognition complaint by the client or caregiver: In our study, participants reported more than one complaint in Everyday Memory Questionnaire and Cognitive Function Questionnaire will be included.
- Objective cognition deficits: participants with scores under 1.5 Standard Deviation in Trail making test, Contextual memory test and Rivermead Behavior Memory Test-3rd edition were included.
- Preserved most daily living function: participants have reported no Activity of Daily Living (ADL) difficulties.
Key exclusion criteria (4 listed)
- A confirmed diagnosis of dementia
- With visual and auditory impairments, and other neurocognitive disease that can potential influence participation in group activities, including stroke, Parkinson's disease and traumatic brain injury, major depression, and substance abuse.
- With Mini Mental Status Exam <=24 (education status beyond primary school); or <=16 (No education)
- With less than 10-session participation rate out of 12.
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 |
|---|---|---|
| cognitive interventiona 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives. | Behavioural | multi-modal cognitive intervention |
| nutritional group12 consecutive 90-minute weekly nutritional groups that included nutrition classes (lecture and discussion). | Behavioural | nutritional group |
Primary outcome
The Mini-Mental State Examination
Time frame: 3 month
cognition
the Trail Making Test
Time frame: 3 month
attention
the Color Trail Test
Time frame: 3 month
attention
Rivermead Behavioral Memory Test
Time frame: 3 month
memory
the Contextual Memory Test
Time frame: 3 month
memory
the Digit Span test
Time frame: 3 month
memory
2 secondary outcomes
Cognitive Failure Questionnaire and the
Time frame: 3 month
Everyday Memory Questionnaire
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No. On-going research. Individual data will only share within the research team.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive intervention and nutritional group in people with Subjective Cognitive Complaints, 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 3 inclusion and 4 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: paused, as of the sponsor's last update on 10 Sep 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?
Results are not available in the source record.
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?
The Mini-Mental State Examination (time frame: 3 month). 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?
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 10 Sep 2020.