Symptom Perception

Icahn School of Medicine at Mount Sinai58 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Asthma

Interventions

PEF FeedbackBEHAVIORAL

Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.

Asthma educationBEHAVIORAL

General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (3)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Albert Einstein College of Medicine/Yeshiva University

The Bronx, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

Asthma Control Questionnaire (ACQ)

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

Time frame: Baseline, 1 week follow up, 1 month follow up

Change in Asthma Quality of Life Questionnaire (AQLQ)

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.

Time frame: Baseline, 1 week follow up, 1 month follow up

Secondary Outcomes

Change in Medication Adherence Rating Scale (MARS)

MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence.

Time frame: Baseline, 1 week follow up, 1 month follow up

Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score

10-item scale that measures beliefs about asthma controller medication in 2 subdomains: necessity and concerns. All items have a ﬁve-point Likert answer option, ranging from 1 = strongly disagree to 5 = strongly agree, with total range from 10 to 50, with higher scores indicate stronger beliefs about the corresponding concepts.

Time frame: Baseline, 1 week follow up, 1 month follow up

Change in Beliefs About Illness Perception Questionnaire (BIPQ)

The BIPQ includes 9 items designed to rapidly assess the cognitive and emotional representations of illness- consequences, timeline, personal control, treatment control, experience symptoms, concerns, emotions and comprehensibility. For analyses, the first 8 items are summed and item 9 which is part of the causal scale is excluded. Items for personal control, treatment control and comprehensibility were reverse coded. All of the 8 items, are rated using a 0 (none) to 10 (extreme) response scale giving a sum total score of 0-80. Higher total scores indicate worse asthma perception.

Data from ClinicalTrials.gov

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