AgingPhase 3NCT00094731
SeniorWISE: Improving Everyday Memory in At-Risk Elderly
A Phase 3 study testing Memory Training in people with Aging, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether classes on memory training will help older adults to improve or maintain their daily activities. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Memory Training
- Type of treatment
- Surgery or procedure
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Feb 2006
- Phase
- Phase 3
- 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
- Reside in Austin, Texas or Travis County
- African, Caucasian, or Hispanic heritage
- Fluent in reading and speaking English
- Mini Mental Exam scores of 23-30
- Pass executive function test
- Adequate hearing and vision to enable participation in classroom learning
- Free of Alzheimer's disease or other conditions (e.g., certain cancers) likely to result in mortality before study completion
Who cannot join
- Under 65
- Score less than 23 on MMSE
- Fail the executive function tests
- Severe sensory losses, hearing or vision, that would prohibit testing or participation
- self-report a diagnosis of Alzheimer's disease or other conditions (e.g., certain cancers) likely to result in mortality before study completion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin, School of Nursing
Austin, Texas, 78701
About this study
Official title: Improving Everyday Memory in At-Risk Elderly
The purpose of this study is to determine whether classes on memory training will help older adults to improve or maintain their daily activities.
Read the detailed description
Volunteer participants will be randomly assigned to experimental (memory training) and comparison (health promotion) groups. Both groups will learn strategies for successful aging. Participants will be in the study for 27 months and will be interviewed on five occasions for 3 hours per interview. The classroom-based intervention is an 8-session, 1 1/2 hour course designed to teach older adults the use of strategies to improve everyday memory. Strategically-placed booster sessions will be provided to subjects within 3 months following the last class session.
- Conditions
- Aging
- Being tested
- Memory Training
- Keywords
- Aging, Memory, Mental Recall, Mental Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory TrainingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2004 (estimated)
- Study startMar 2001
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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 3
- Allocation
- Randomised
- Enrolment
- 260 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Graham McDougall, PhD, RN, Principal investigator, University of Texas at Austin, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094731
- Sponsor's protocol ID
- AG0008
- Other IDs
- R01AG015384
- Status last verified
- Feb 2006
- First submitted
- 21 Oct 2004
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
McDougall GJ, Montgomery KS, Eddy N, Jackson E, Nelson E, Stark T, Thomsen C. Aging memory self-efficacy: elders share their thoughts and experience. Geriatr Nurs. 2003 May-Jun;24(3):162-8. doi: 10.1067/mgn.2003.43.
PubMed 12813430McDougall GJ. Memory improvement in octogenarians. Appl Nurs Res. 2002 Feb;15(1):2-10. doi: 10.1053/apnr.2002.29518.
PubMed 11840404McDougall GJ. I remember that! Building memory confidence in the elderly. Reflect Nurs Leadersh. 2001;27(1):23-5, 45. No abstract available.
PubMed 11987351Zimmerman T, McDougall GJ Jr, Becker H. Older women's cognitive and affective response to moderate drinking. Int J Geriatr Psychiatry. 2004 Nov;19(11):1095-102. doi: 10.1002/gps.1216.
PubMed 15481070Austin-Wells V, Zimmerman T, McDougall GJ. ANOPTIMAL DELIVERYFORMATFORPRESENTATIONS TARGETINGOLDER ADULTS. Educ Gerontol. 2003;29(6):493-501. doi: 10.1080/713844396.
PubMed 18841248McDougall GJ, Becker H, Acee TW, Vaughan PW, Delville CL. Symptom management of affective and cognitive disturbance with a group of cancer survivors. Arch Psychiatr Nurs. 2011 Feb;25(1):24-35. doi: 10.1016/j.apnu.2010.05.004. Epub 2010 Jul 23.
PubMed 21251599McDougall GJ Jr, Becker H, Pituch K, Acee TW, Vaughan PW, Delville CL. The SeniorWISE study: improving everyday memory in older adults. Arch Psychiatr Nurs. 2010 Oct;24(5):291-306. doi: 10.1016/j.apnu.2009.11.001. Epub 2010 Jan 15.
PubMed 20851321McDougall GJ Jr, Becker H, Pituch K, Acee TW, Vaughan PW, Delville CL. Differential benefits of memory training for minority older adults in the SeniorWISE study. Gerontologist. 2010 Oct;50(5):632-45. doi: 10.1093/geront/gnq017. Epub 2010 Mar 4.
PubMed 20203096
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Everyday Memory in At-Risk Elderly
- ClinicalTrials.gov ID
- NCT00094731
- Acronym / sponsor ID
- AG0008
- Conditions
- Aging
- Keywords
- Aging, Memory, Mental Recall, Mental Processes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Mar 2001
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 22 Oct 2004 (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.
The purpose of this study is to determine whether classes on memory training will help older adults to improve or maintain their daily activities.
Detailed description
Volunteer participants will be randomly assigned to experimental (memory training) and comparison (health promotion) groups. Both groups will learn strategies for successful aging. Participants will be in the study for 27 months and will be interviewed on five occasions for 3 hours per interview. The classroom-based intervention is an 8-session, 1 1/2 hour course designed to teach older adults the use of strategies to improve everyday memory. Strategically-placed booster sessions will be provided to subjects within 3 months following the last class session.
Study design
- Allocation
- Randomised
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Reside in Austin, Texas or Travis County
- African, Caucasian, or Hispanic heritage
- Fluent in reading and speaking English
- Mini Mental Exam scores of 23-30
- Pass executive function test
Key exclusion criteria (5 listed)
- Under 65
- Score less than 23 on MMSE
- Fail the executive function tests
- Severe sensory losses, hearing or vision, that would prohibit testing or participation
- self-report a diagnosis of Alzheimer's disease or other conditions (e.g., certain cancers) likely to result in mortality before study completion
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 Training | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 11 Dec 2009.
- Background: PubMed 12813430McDougall GJ, Montgomery KS, Eddy N, Jackson E, Nelson E, Stark T, Thomsen C. Aging memory self-efficacy: elders share their thoughts and experience. Geriatr Nurs. 2003 May-Jun;24(3):162-8. doi: 10.1067/mgn.2003.43.
- Background: PubMed 11840404McDougall GJ. Memory improvement in octogenarians. Appl Nurs Res. 2002 Feb;15(1):2-10. doi: 10.1053/apnr.2002.29518.
- Background: PubMed 11987351McDougall GJ. I remember that! Building memory confidence in the elderly. Reflect Nurs Leadersh. 2001;27(1):23-5, 45. No abstract available.
- Background: PubMed 15481070Zimmerman T, McDougall GJ Jr, Becker H. Older women's cognitive and affective response to moderate drinking. Int J Geriatr Psychiatry. 2004 Nov;19(11):1095-102. doi: 10.1002/gps.1216.
- Background: PubMed 18841248Austin-Wells V, Zimmerman T, McDougall GJ. ANOPTIMAL DELIVERYFORMATFORPRESENTATIONS TARGETINGOLDER ADULTS. Educ Gerontol. 2003;29(6):493-501. doi: 10.1080/713844396.
- Derived from this study: PubMed 21251599McDougall GJ, Becker H, Acee TW, Vaughan PW, Delville CL. Symptom management of affective and cognitive disturbance with a group of cancer survivors. Arch Psychiatr Nurs. 2011 Feb;25(1):24-35. doi: 10.1016/j.apnu.2010.05.004. Epub 2010 Jul 23.
- Derived from this study: PubMed 20851321McDougall GJ Jr, Becker H, Pituch K, Acee TW, Vaughan PW, Delville CL. The SeniorWISE study: improving everyday memory in older adults. Arch Psychiatr Nurs. 2010 Oct;24(5):291-306. doi: 10.1016/j.apnu.2009.11.001. Epub 2010 Jan 15.
- Derived from this study: PubMed 20203096McDougall GJ Jr, Becker H, Pituch K, Acee TW, Vaughan PW, Delville CL. Differential benefits of memory training for minority older adults in the SeniorWISE study. Gerontologist. 2010 Oct;50(5):632-45. doi: 10.1093/geront/gnq017. Epub 2010 Mar 4.
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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.
Graham McDougall, PhD, RN principal investigator
University of Texas at Austin, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Memory Training in people with Aging, run by National Institute on Aging (NIA) at 1 site in United States.
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 7 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 11 Dec 2009. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00094731, which also lists 8 linked publications.
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 11 Dec 2009.