- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00786344
USC Well Elderly Study 2
Health Mediating Effects of the Well Elderly Program
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90089-9003
- University of Southern California
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Lifestyle Redesign
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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.
Andre navne:
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Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Perceived Physical Health
Tidsramme: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Psychosocial Well-Being
Tidsramme: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Cognitive Functioning
Tidsramme: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Healthy Activity
Tidsramme: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Active Coping
Tidsramme: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Perceived Control
Tidsramme: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Social Support
Tidsramme: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Positive Reinterpretation-Based Coping
Tidsramme: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Stress-Related Biomarkers
Tidsramme: within 1 month of completion of intervention
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within 1 month of completion of intervention
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Florence A Clark, PhD, OTR/L, University of Southern California
Publikationer og nyttige links
Generelle publikationer
- Leland NE, Fogelberg D, Sleight A, Mallinson T, Vigen C, Blanchard J, Carlson M, Clark F. Napping and Nighttime Sleep: Findings From an Occupation-Based Intervention. Am J Occup Ther. 2016 Jul-Aug;70(4):7004270010p1-7. doi: 10.5014/ajot.2016.017657.
- Clark F, Jackson J, Carlson M, Chou CP, Cherry BJ, Jordan-Marsh M, Knight BG, Mandel D, Blanchard J, Granger DA, Wilcox RR, Lai MY, White B, Hay J, Lam C, Marterella A, Azen SP. Effectiveness of a lifestyle intervention in promoting the well-being of independently living older people: results of the Well Elderly 2 Randomised Controlled Trial. J Epidemiol Community Health. 2012 Sep;66(9):782-90. doi: 10.1136/jech.2009.099754. Epub 2011 Jun 2. Erratum In: J Epidemiol Community Health. 2012 Nov;66(11):1082.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 5R01AG021108-04 (U.S. NIH-bevilling/kontrakt)
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Kliniske forsøg med Lifestyle Redesign
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HealthPartners InstituteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetForhøjet blodtryk | Diabetes mellitus | HyperlipidæmiForenede Stater
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