Clinical trial NCT03646669: Symptom Perception
Official title: Symptom Perception, Behavior, and Outcomes in Older Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Older adults
Asthma
Symptom perception
Self-management behaviors
Medication adherence
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
name: Jacobi Medical Center
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-08-24
Enrollment: 58
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Asthma Control Questionnaire (ACQ)
timeFrame: Baseline, 1 week follow up, 1 month follow up
measure: Change in Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Baseline, 1 week follow up, 1 month follow up
Secondary outcomes:
measure: Change in Medication Adherence Rating Scale (MARS)
timeFrame: Baseline, 1 week follow up, 1 month follow up
measure: Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score
timeFrame: Baseline, 1 week follow up, 1 month follow up
measure: Change in Beliefs About Illness Perception Questionnaire (BIPQ)
timeFrame: Baseline, 1 week follow up
measure: Symptom Perception Measures Adjusted
timeFrame: Baseline, 1 week follow up, 1 month follow up
measure: Asthma Control Questionnaire (ACQ) Score - Adjusted
timeFrame: Baseline, 1 week follow up, 1 month follow up
measure: Treatment Credibility
timeFrame: 1 week follow up, 1 month follow up
measure: Treatment Expectancy
timeFrame: 1 week follow up, 1 month follow up
measure: Change in Medication Adherence Rating Scale (MARS) Adjusted
timeFrame: Baseline, 1 week follow up, 1 month follow up
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine/Yeshiva University
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Juan Wisnivesky, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: