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USC Well Elderly Study 2

4. november 2008 opdateret af: University of Southern California

Health Mediating Effects of the Well Elderly Program

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

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

Interventionel

Tilmelding (Faktiske)

460

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • California
      • Los Angeles, California, Forenede Stater, 90089-9003
        • University of Southern California

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

Andre navne:
  • Well Elderly Intervention
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Perceived Physical Health
Tidsramme: within 1 month of completion of intervention
within 1 month of completion of intervention
Psychosocial Well-Being
Tidsramme: within 1 month of completion of intervention
within 1 month of completion of intervention
Cognitive Functioning
Tidsramme: within 1 month of completion of intervention
within 1 month of completion of intervention

Sekundære resultatmål

Resultatmål
Tidsramme
Healthy Activity
Tidsramme: within 1 month of completion of intervention
within 1 month of completion of intervention
Active Coping
Tidsramme: within 1 month of completion of intervention
within 1 month of completion of intervention
Perceived Control
Tidsramme: within 1 month of completion of intervention
within 1 month of completion of intervention
Social Support
Tidsramme: within 1 month of completion of intervention
within 1 month of completion of intervention
Positive Reinterpretation-Based Coping
Tidsramme: within 1 month of completion of intervention
within 1 month of completion of intervention
Stress-Related Biomarkers
Tidsramme: within 1 month of completion of intervention
within 1 month of completion of intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Florence A Clark, PhD, OTR/L, University of Southern California

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2004

Primær færdiggørelse (Faktiske)

1. oktober 2008

Studieafslutning (Faktiske)

1. oktober 2008

Datoer for studieregistrering

Først indsendt

4. november 2008

Først indsendt, der opfyldte QC-kriterier

4. november 2008

Først opslået (Skøn)

6. november 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. november 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2008

Sidst verificeret

1. oktober 2008

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 5R01AG021108-04 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lifestyle Redesign

3
Abonner