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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00079651
Other study ID # R21MH063395
Secondary ID R21MH063395DATR
Status Completed
Phase Phase 2/Phase 3
First received March 10, 2004
Last updated November 21, 2013
Start date December 2002
Est. completion date July 2005

Study information

Verified date November 2013
Source Menorah Park
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will determine whether montessori-based activities can help older adults with dementia become more responsive to others.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date July 2005
Est. primary completion date April 2005
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of dementia

- Living in or attending programs at participating sites

Exclusion Criteria:

- Medical conditions that would interfere with study participation

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
Montessori-based dementia programming


Locations

Country Name City State
United States Mandel Adult Day Program Beachwood Ohio
United States Stone Gardens Beachwood Ohio
United States Eliza Bryant Village Cleveland Ohio
United States Jennings Center for Older Adults Cleveland Ohio
United States The Greens Adult Living Communities Lyndhurst Ohio

Sponsors (2)

Lead Sponsor Collaborator
Menorah Park National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

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