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USC Well Elderly Study 2

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ClinicalTrials.gov Identifier: NCT00786344
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : November 6, 2008
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by:
University of Southern California

Tracking Information
First Submitted Date  ICMJE November 4, 2008
First Posted Date  ICMJE November 6, 2008
Last Update Posted Date November 6, 2008
Study Start Date  ICMJE November 2004
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2008)
  • Perceived Physical Health [ Time Frame: within 1 month of completion of intervention ]
  • Psychosocial Well-Being [ Time Frame: within 1 month of completion of intervention ]
  • Cognitive Functioning [ Time Frame: within 1 month of completion of intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2008)
  • Healthy Activity [ Time Frame: within 1 month of completion of intervention ]
  • Active Coping [ Time Frame: within 1 month of completion of intervention ]
  • Perceived Control [ Time Frame: within 1 month of completion of intervention ]
  • Social Support [ Time Frame: within 1 month of completion of intervention ]
  • Positive Reinterpretation-Based Coping [ Time Frame: within 1 month of completion of intervention ]
  • Stress-Related Biomarkers [ Time Frame: within 1 month of completion of intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE USC Well Elderly Study 2
Official Title  ICMJE Health Mediating Effects of the Well Elderly Program
Brief Summary The purpose of this study is to learn how activity promotes health and well being among older adults. There are two main study goals: (1) to extend the previous results obtained for the Well Elderly Study 1; and (2) to determine what factors make the program successful.
Detailed Description

Previous theory and research implicates participation in meaningful activity as an important factor in enhancing older adults' health-related quality of life. Consistent with this emphasis, a previous R01 grant completed by our study group demonstrated that an activity-based intervention (the Well Elderly Intervention) reduced declines in a wide variety of health-related parameters among low income, ethnically diverse elders. In the current four-year project, we attempted to replicate our previous result while simultaneously examining the mediating mechanisms responsible for its positive effects. The outcomes of this study will provide important new information about the process events by which activity-based lifestyle interventions influence key aging outcomes.

In the study, 460 ethnically diverse elders were recruited from 21 sites in the greater Los Angeles area, and participated in a randomized experiment containing a semi-crossover design component. The sites included 9 senior citizen centers (Culver City Senior Center, Estelle Van Meter Multipurpose Center, Hawthorne Senior Center, Hollywood Senior Multipurpose Center, Joslyn Adult Center - Burbank, Lennox Senior Center, Long Beach Senior Center, St. Barnabas Senior Center, and Slauson Recreation Center), as well as 12 senior residences (Casa TELACU, Covenant Manor, Eucalyptus Park, George McDonald Court, Motion Picture and Television Fund, Pilgrim Towers East, Regent Plaza, TELACU Del Rio, TELACU Manor, TELACU Senior Housing, TELACU Terrace, and Ward Villas).

Within either the first or second six-month phase of their study involvement, each subject received a lifestyle-based intervention designed to improve a variety of aging outcomes. At 4-5 points in time over an 18-24 month interval, elders completed assessments of healthy activity, coping, social support, perceived control, stress-related biomarkers, perceived physical health, psychosocial well-being, and cognitive functioning to test the efficacy of the intervention and document the process mechanisms responsible for its effects.

The study has three long-term objectives. First, it will lead to more effective health care services for our nation's rapidly growing elderly population, thereby fulfilling a major policy priority for older adults, namely, preventing declines in their health and independence. Second, it will generate new information regarding how activity influences aging outcomes. Although previous research has shown that activity patterns consistently relate to important aging outcomes, little is known about how the psychological and biological changes that stem from activities combine to promote successful aging. This study will reduce this knowledge gap. Third, due to the significant ethnic diversity at the study sites, the project will produce results that generalize to minority elders. This outcome is important due to the increasing ethnic diversity of our nation's aging population.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Condition  ICMJE Aged
Intervention  ICMJE Behavioral: Lifestyle Redesign

For a six-month period, each elder participated in weekly 2-hour sessions involving groups of size 8-10, and also received up to 10 hours of individualized treatment over this time period.

Modular treatment units included the following content areas: (1) Introduction to the Power of Activity; (2) Aging, Health, and Activity; (3) Transportation; (4) Safety; (5) Social Relationships; (6) Cultural Awareness; (7) Finances; and (8) Integrative Summary: Lifestyle Redesign Notebook. The methods of program delivery consisted of didactic presentation, peer exchange, direct experience, and personal exploration. Treatment materials were translated into Spanish and culturally adapted for approximately 15% of the subjects.

Other Name: Well Elderly Intervention
Study Arms  ICMJE
  • Experimental: Lifestyle Redesign
    Intervention: Behavioral: Lifestyle Redesign
  • No Intervention: No Treatment Control
    The no treatment control arm did not receive the intervention during the first six-month period. However the intervention, which has been proven to be beneficial, was administered to the control arm immediately following the 6 month assessment.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2008)
460
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fluent speaker of English or Spanish
  • Living in the community

Exclusion Criteria:

  • Hospitalized
  • Living in nursing home
  • Mental confusion/dementia
  • Participation in the first Well Elderly Study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00786344
Other Study ID Numbers  ICMJE 5R01AG021108-04( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Florence Clark, PhD, OTR/L, FAOTA; Principal Investigator, USC Division of Occupational Science & Occupational Therapy
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Florence A Clark, PhD, OTR/L University of Southern California
PRS Account University of Southern California
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP