DementiaPhase 2/3NCT00079651
Montessori-Based Activities for Elderly Persons With Dementia
A Phase 2/3 study testing Montessori-based dementia programming in people with Dementia, run by Menorah Park at 5 sites in United States.
Trial summary
This study will determine whether montessori-based activities can help older adults with dementia become more responsive to others. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Montessori-based dementia programming
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2002to Jul 2005
- Phase
- Phase 2/3
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dementia
- Living in or attending programs at participating sites
Who cannot join
- Medical conditions that would interfere with study participation
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mandel Adult Day Program
Beachwood, Ohio, 44122
Stone Gardens
Beachwood, Ohio, 44122
Eliza Bryant Village
Cleveland, Ohio, 44103
Jennings Center for Older Adults
Cleveland, Ohio, 44125
The Greens Adult Living Communities
Lyndhurst, Ohio, 44124
About this study
Official title: Programming for Dementia: Maximizing Abilities
This study will determine whether montessori-based activities can help older adults with dementia become more responsive to others.
Read the detailed description
Studies have shown that Montessori-based activities, which focus on developing an individual's unique abilities, are effective in increasing engagement between nursing home residents with dementia and their caregivers. This study will determine whether the positive effects of Montessori-based programming can be replicated in adult day care, assisted living, and nursing homes. Results from this study will be used to create training materials to help staff in different settings implement the intervention within existing schedules, staffing, and programming routines.
This study will be conducted in two phases. During Phase I, participants with mild dementia will be trained to become small group leaders for Montessori-based activities. In Phase II, newly-trained participants will use their skills to assist others. Assessments will be made throughout the study. Participants' engagement with the environment and caregiver burden and satisfaction will be assessed.
- Conditions
- Dementia
- Being tested
- Montessori-based dementia programming
- Keywords
- Aged, Nursing Homes, Assisted Living Facilities
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montessori-based dementia programmingBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2004 (estimated)
- Study startDec 2002
- Primary completionApr 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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 2/3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Menorah Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Cameron J. Camp, PhD, Principal investigator, Myers Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079651
- Sponsor's protocol ID
- R21MH063395
- Other IDs
- R21MH063395, DATR A4-GPS
- Status last verified
- Nov 2013
- First submitted
- 10 Mar 2004
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programming for Dementia: Maximizing Abilities
- ClinicalTrials.gov ID
- NCT00079651
- Acronym / sponsor ID
- R21MH063395
- Conditions
- Dementia
- Keywords
- Aged, Nursing Homes, Assisted Living Facilities
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Menorah ParkUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2002
- Primary completion
- Apr 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 12 Mar 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.
This study will determine whether montessori-based activities can help older adults with dementia become more responsive to others.
Detailed description
Studies have shown that Montessori-based activities, which focus on developing an individual's unique abilities, are effective in increasing engagement between nursing home residents with dementia and their caregivers. This study will determine whether the positive effects of Montessori-based programming can be replicated in adult day care, assisted living, and nursing homes. Results from this study will be used to create training materials to help staff in different settings implement the intervention within existing schedules, staffing, and programming routines.
This study will be conducted in two phases. During Phase I, participants with mild dementia will be trained to become small group leaders for Montessori-based activities. In Phase II, newly-trained participants will use their skills to assist others. Assessments will be made throughout the study. Participants' engagement with the environment and caregiver burden and satisfaction will be assessed.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of dementia
- Living in or attending programs at participating sites
Key exclusion criteria (1 listed)
- Medical conditions that would interfere with study participation
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 |
|---|---|---|
| Montessori-based dementia programming | Behavioural | – |
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 25 Nov 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.
Cameron J. Camp, PhD principal investigator
Myers Research Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Montessori-based dementia programming in people with Dementia, run by Menorah Park at 5 sites 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 2 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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 25 Nov 2013.