Identifying and Treating Physical Function Impairment in Elders
Sedentary older adults are more likely to develop physical function impairments than active older adults. Physical function measured by slow usual gait speed predicts the risk of future falls, disability, institutionalization and mortality. Behavioral physical activity interventions have improved physical activity and physical function, but have not generally been implemented where they may have the most impact -- primary care settings. In part, this is due to the limited time and training for clinical staff to screen for physical function impairment and to treat with physical activity counseling. The proposed scientific goal is to overcome these barriers by adapting an evidence-based screening tool and telephone-based physical activity intervention into primary care settings.
Aim1: Among older adults who screen positive for physical function impairment, to determine the estimated intervention effect size of a 12-week behavioral intervention on physical activity and physical function.
Hypothesis 1a: Physical activity levels will increase more in the intervention vs. usual care group.
Hypothesis 1b: Physical function will increase more in the intervention vs. usual care group.
Aim 2: Among Aim 1 participants and clinical staff who deliver the functional screening and Aim 1 intervention, to evaluate standard implementation science process metrics of reach, acceptability, and implementation
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Anschutz Medical Campus
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Sedentary patients aged 65-85 years who screen positive for physical function impairment (Physical function impairment includes any of the following: time to complete 4-meter walk ≥4.82 seconds (i.e., ≥0.83 meters/second); a reported fall in the past 3 months; or a reported fear of falling)
Exclusion Criteria:
- Inability to walk ≥30 feet without human assistance7
- Dementia, as assessed by either a Folstein Mini-Mental Status Examination <24 or by patient's primary care provider's assessment
- Severe vision loss (legally blind)
- Severe hearing loss
- Medical condition that precludes increasing physical activity per primary care provider's assessment
- Terminal diagnosis per primary care provider's assessment
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Behavioral Intervention
Behavioral Counseling Intervention: 6 telephone calls that include physical activity goal-setting, tracking,and problem-solving of barriers
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Inget ingripande: Usual Care
Monthly mailed print materials on aging topics (that would generally be administered by subjects' primary care clinic).
No behavioral counseling.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in physical activity as determined by accelerometer
Tidsram: 12 weeks
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Subjects' physical activity levels will be determined by accelerometer measures during week 1 and after a 12-week behavioral intervention.
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12 weeks
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Changes in physical function as assessed by 400-meter walk speed
Tidsram: 12 weeks
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Subjects' physical function will be assessed by 400-meter walk speed before and after 12-week behavioral intervention.
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12 weeks
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Changes in physical function as assessed by Short Physical Performance Battery
Tidsram: 12 weeks
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Subjects' physical function will be assessed by the Short Physical Performance Battery before and after a 12-week intervention
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12 weeks
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Change in physical function as assessed by lower extremity strength testing
Tidsram: 12 weeks
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Subjects' physical function will be assessed by lower extremity strength testing before and after a 12-week behavioral intervention .
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12 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evaluation of standard implementation science process of reach
Tidsram: 1 year
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Reach is the percent of patients consented divided by the number eligible.
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1 year
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Assessment of standard implementation science process metrics of acceptability
Tidsram: 1 year
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Acceptability will be assessed through structured surveys.
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1 year
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Assessment of standard implementation science process metrics of implementation
Tidsram: 1 year
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Implementation process will be assessed by structured surveys
|
1 year
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Amy Huebschmann, MD, University of Colorado - Anschutz Medical Campus
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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