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USC Well Elderly Study 2

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00786344
First received: November 4, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Aged
Behavioral: Lifestyle Redesign

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Official Title: Health Mediating Effects of the Well Elderly Program

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Perceived Physical Health [ Time Frame: within 1 month of completion of intervention ] [ Designated as safety issue: No ]
  • Psychosocial Well-Being [ Time Frame: within 1 month of completion of intervention ] [ Designated as safety issue: No ]
  • Cognitive Functioning [ Time Frame: within 1 month of completion of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Healthy Activity [ Time Frame: within 1 month of completion of intervention ] [ Designated as safety issue: No ]
  • Active Coping [ Time Frame: within 1 month of completion of intervention ] [ Designated as safety issue: No ]
  • Perceived Control [ Time Frame: within 1 month of completion of intervention ] [ Designated as safety issue: No ]
  • Social Support [ Time Frame: within 1 month of completion of intervention ] [ Designated as safety issue: No ]
  • Positive Reinterpretation-Based Coping [ Time Frame: within 1 month of completion of intervention ] [ Designated as safety issue: No ]
  • Stress-Related Biomarkers [ Time Frame: within 1 month of completion of intervention ] [ Designated as safety issue: No ]

Enrollment: 460
Study Start Date: November 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle Redesign 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
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786344

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90089-9003
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Florence A Clark, PhD, OTR/L University of Southern California
  More Information

No publications provided

Responsible Party: Florence Clark, PhD, OTR/L, FAOTA; Principal Investigator, USC Division of Occupational Science & Occupational Therapy
ClinicalTrials.gov Identifier: NCT00786344     History of Changes
Other Study ID Numbers: 5R01AG021108-04
Study First Received: November 4, 2008
Last Updated: November 4, 2008
Health Authority: United States: Federal Government

Keywords provided by University of Southern California:
Health Promotion: Wellness Programs
Occupational Therapy
Quality of Life
Health
Biomarkers

ClinicalTrials.gov processed this record on November 27, 2014