Mild Cognitive ImpairmentNCT01998711
Impact of a Memory Group for Older Adults Reporting Memory Difficulties
A study testing Memory group in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Bayside Health at 1 site in Australia.
Trial summary
Aims: To evaluate the efficacy of a brief intensive intervention for persons with mild cognitive impairment, assisted by family members or friends. To equip persons with mild cognitive impairment with specific skills to prevent memory failures and improve the capacity of patients and families to cope with everyday… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer's Disease
- What is being tested?
- Memory group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2004to Nov 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participant presents with memory complaint Objective memory impairment on neuropsychological tests Normal general cognitive function Adequate activities of daily living Fails to reach criterion for clinical dementia according to NINCDS-ADRDA guidelines Living in the community Absence of significant visual or auditory impairment English speaker -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Memory Group Intervention for Mild Cognitive Impairment: Impact of a Memory Group for Older Adults Reporting Memory Difficulties.
Aims:
To evaluate the efficacy of a brief intensive intervention for persons with mild cognitive impairment, assisted by family members or friends. To equip persons with mild cognitive impairment with specific skills to prevent memory failures and improve the capacity of patients and families to cope with everyday memory difficulties.
Read the detailed description
Participants:
The sample will consist of 60 families who have a family member reporting memory loss and who have recently been assessed within the Cognitive Dementia and Memory Service (CDAMS). Participants will include patients and a family member / close friend. The potential patient participants must have received a diagnosis of mild cognitive impairment following a comprehensive clinical assessment. They must also be English speakers, live in the community, have no evidence of significant visual or auditory impairment, and have no history of diagnosed alcohol or drug abuse or major psychological disorder. Potential family / friend participants are expected to be spouses or adult children.
Brief Description:
Patients and their carers will be assigned to either a 'brief intervention group' or a 'no intervention group'. Over 5 1 1/2 -hour weekly sessions, the brief intervention group will be taught a memory skills program which emphasises practical strategies for dealing with everyday memory problems. Interactive group discussion and 'take home' exercises are also included. The no intervention group will serve as a control group, and will receive only their usual care from the the memory clinic. At the completion of the study, the brief intervention will be offered to those in the no intervention group.
All participants will complete questionnaires about knowledge of memory techniques, common memory and behaviour problems and emotional health at pre-intervention, post-intervention and after a 3-month follow-up.
Methods of Data Analysis:
Outcome evaluation will be monitored by neuropsychological assessments of memory performance, and subjective self-reports. A 2 x 3 multivariate analysis of variance (MANOVA) will be used to assess differences on the experimental measures between groups (brief intervention, no intervention) across repeated assessment phases (pre-intervention, post-intervention, 3-month follow-up).
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Being tested
- Memory group
- Keywords
- Alzheimer's disease, Mild cognitive impairment, Memory intervention, Strategy use, Memory group
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory groupBehavioural
Five 1-1.5 hour weekly session of memory training
| Study group | Role | What they receive |
|---|---|---|
| Memory group | Experimental | Memory training Receives: Behavioral: Memory group |
| Control | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological measures of memory and attention
Self-report on memory performance in everyday activities
Self-report on use of memory strategies
Informant report on memory performance in everyday activities
Informant report on use of strategies
Assessment of psychological wellbeing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startOct 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Glynda J Kinsella, PhD, Principal investigator, Caulfield General Medical Centre - Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998711
- Sponsor's protocol ID
- 156/04
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory Group Intervention for Mild Cognitive Impairment: Impact of a Memory Group for Older Adults Reporting Memory Difficulties.
- ClinicalTrials.gov ID
- NCT01998711
- Acronym / sponsor ID
- 156/04
- Conditions
- Mild Cognitive Impairment, Alzheimer's Disease
- Keywords
- Alzheimer's disease, Mild cognitive impairment, Memory intervention, Strategy use, Memory group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Study start
- Oct 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 2 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.
Aims:
To evaluate the efficacy of a brief intensive intervention for persons with mild cognitive impairment, assisted by family members or friends. To equip persons with mild cognitive impairment with specific skills to prevent memory failures and improve the capacity of patients and families to cope with everyday memory difficulties.
Detailed description
Participants:
The sample will consist of 60 families who have a family member reporting memory loss and who have recently been assessed within the Cognitive Dementia and Memory Service (CDAMS). Participants will include patients and a family member / close friend. The potential patient participants must have received a diagnosis of mild cognitive impairment following a comprehensive clinical assessment. They must also be English speakers, live in the community, have no evidence of significant visual or auditory impairment, and have no history of diagnosed alcohol or drug abuse or major psychological disorder. Potential family / friend participants are expected to be spouses or adult children.
Brief Description:
Patients and their carers will be assigned to either a 'brief intervention group' or a 'no intervention group'. Over 5 1 1/2 -hour weekly sessions, the brief intervention group will be taught a memory skills program which emphasises practical strategies for dealing with everyday memory problems. Interactive group discussion and 'take home' exercises are also included. The no intervention group will serve as a control group, and will receive only their usual care from the the memory clinic. At the completion of the study, the brief intervention will be offered to those in the no intervention group.
All participants will complete questionnaires about knowledge of memory techniques, common memory and behaviour problems and emotional health at pre-intervention, post-intervention and after a 3-month follow-up.
Methods of Data Analysis:
Outcome evaluation will be monitored by neuropsychological assessments of memory performance, and subjective self-reports. A 2 x 3 multivariate analysis of variance (MANOVA) will be used to assess differences on the experimental measures between groups (brief intervention, no intervention) across repeated assessment phases (pre-intervention, post-intervention, 3-month follow-up).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memory group | Experimental | Behavioral: Memory groupMemory training |
| Control | No intervention | –Standard care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participant presents with memory complaint Objective memory impairment on neuropsychological tests Normal general cognitive function Adequate activities of daily living Fails to reach criterion for clinical dementia according to NINCDS-ADRDA guidelines Living in the community Absence of significant visual or auditory impairment English speaker -
Key exclusion criteria (1 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 |
|---|---|---|
| Memory groupFive 1-1.5 hour weekly session of memory training | Behavioural | Memory group |
Primary outcome
Neuropsychological measures of memory and attention
Self-report on memory performance in everyday activities
Self-report on use of memory strategies
Informant report on memory performance in everyday activities
Informant report on use of strategies
Assessment of psychological wellbeing
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 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.
Glynda J Kinsella, PhD principal investigator
Caulfield General Medical Centre - Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory group in people with Mild Cognitive Impairment and Alzheimer's Disease, run by Bayside Health at 1 site in Australia.
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 2 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 Australia. 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?
Neuropsychological measures of memory and attention. 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 2 Dec 2013.