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临床试验/NCT03646669
NCT03646669已完成不适用

Symptom Perception, Behavior, and Outcomes in Older Asthmatics

Icahn School of Medicine at Mount Sinai5 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2019年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
5
主要终点
Asthma Control Questionnaire (ACQ)

研究概览

简要总结

Older asthmatics have considerably worse outcomes than younger patients with asthma. In this study, the investigators will evaluate the role of symptom perception as a key determinant of poorer outcomes and lower adherence to asthma self-management behaviors among older asthmatics. The proposed study is significant for its potential to greatly advance understanding of the mechanisms related to worse outcomes in older adults, and it will provide actionable data for new interventions to improve self-management.

详细描述

Asthma is a common condition in the older population and associated with worse morbidity and mortality compared to younger individuals. Various self-management behaviors (SMB), medication adherence in particular, are key for achieving good asthma control. Unfortunately, less than half of older asthmatics regularly adhere to their controller medications and to other SMB. Several observations suggest that symptom perception may be a major determinant of asthma SMB and outcomes in older adults. First, experimental studies consistently demonstrate that many older adults are substantially less aware of their level of airway obstruction. Second, under-perception of asthma symptoms is linked to elevated risk of near-fatal and fatal asthma attacks and increased morbidity among younger adults. Third, cognitive impairment, commonly associated with aging, has been identified as a key determinant of under-perception of symptoms in younger asthmatics. Fourth, interventions to correct symptom under-perception in children have been shown to improve asthma medication adherence. Despite the greater vulnerability of older asthmatics to poor asthma outcomes and their diminished ability to perceive the severity of their airway obstruction, the association of symptom perception with asthma SMB and outcomes has not been studied in this population. The goal of this project is to determine how symptom perception influences the management and outcomes of older asthmatics and to pilot test an intervention to correct under-perception. The Specific Aims are: 1) Prospectively assess the association between symptom perception and asthma morbidity among older adults; 2) Examine the association between symptom perception and asthma SMB among older adults and identify the pathways (via illness and medication beliefs) linking them; 3) Determine the influence of cognition on symptom perception among older adults with asthma; 4) Pilot test an intervention to correct under-perceptions of asthma symptoms in older adults. The investigators will conduct a prospective cohort study of 400 asthmatics ≥60 years of age recruited from East Harlem and the Bronx in New York City. The investigators will measure symptom perception in naturalistic settings using an innovative and validated methodology and repeatedly collect data on illness and medication beliefs, cognitive functioning, SMB (including objective measures of medication adherence), and asthma morbidity over 12 months. At the end of the observation period, the investigators will pilot test an intervention to improve symptom perception on a random sample of 80 participants. The proposed study is significant for its potential to greatly advance understanding of the mechanisms related to low adherence to SMB and worse outcomes in older asthmatics, a vulnerable and understudied population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥60 years
  • English or Spanish speaking
  • Asthma diagnosis made by a health care provider

排除标准

  • Diagnosis of dementia
  • Diagnosis of chronic obstructive pulmonary disease (COPD) or other chronic respiratory illness
  • Smoking history of ≥15 pack-years owing to possible undiagnosed COPD
  • Moderate or severe cardiac disease (including New York Heart Association stages 4 or 5 congestive heart failure, because dyspnea among patients with severe heart failure is more likely to be attributable to their heart condition than their asthma)
  • Dependence on assistance for medication administration
  • Uncorrectable visual impairment

结局指标

主要结局

Asthma Control Questionnaire (ACQ)

时间窗: Baseline, 1 week follow up, 1 month follow up

Change in self-reported asthma control validated survey, with a total score range from 0-6, with a higher score indicating severely uncontrolled asthma , used to assess current asthma control at pre-intervention, 1week post-pilot follow up visit and 4 weeks post-pilot follow-up visit

Change in Asthma Quality of Life Questionnaire (AQLQ)

时间窗: Baseline, 1 week follow up, 1 month follow up

Change in self-reported asthma-related quality of life validated survey used to assess asthma-related quality of life at at pre-intervention, 1week post-pilot follow up visit and 4 weeks post-pilot follow-up visit. Total Score from 1-7, with higher score indicating better quality of life.

次要结局

  • Change in Beliefs About Illness Perception Questionnaire (BIPQ)(Baseline, 1 week follow up)
  • Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score(Baseline, 1 week follow up, 1 month follow up)
  • Change in Medication Adherence Rating Scale (MARS)(Baseline, 1 week follow up, 1 month follow up)
  • Asthma Control Questionnaire (ACQ) Score - Adjusted(Baseline, 1 week follow up, 1 month follow up)
  • Treatment Credibility(1 week follow up, 1 month follow up)
  • Change in Medication Adherence Rating Scale (MARS) Adjusted(Baseline, 1 week follow up, 1 month follow up)
  • Symptom Perception Measures Adjusted(Baseline, 1 week follow up, 1 month follow up)
  • Treatment Expectancy(1 week follow up, 1 month follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan P Wisnivesky

Professor of Medicine and Chief, Division of General Internal Medicine

Icahn School of Medicine at Mount Sinai

研究点 (5)

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