Symptom Perception

NCT ID: NCT03646669

Last Updated: 2023-05-06

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2022-04-01

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Asthma education and PEF feedback

Patients receive asthma education and personal Peak expiratory flow (PEF) feedback

Group Type EXPERIMENTAL

PEF Feedback

Intervention Type BEHAVIORAL

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 education

No PEF feedback arm

Group Type PLACEBO_COMPARATOR

Asthma education

Intervention Type BEHAVIORAL

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.

Interventions

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PEF Feedback

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.

Intervention Type BEHAVIORAL

Asthma education

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Intervention Arm

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albert Einstein College of Medicine

OTHER

Sponsor Role collaborator

Jacobi Medical Center

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Juan P Wisnivesky

Professor of Medicine and Chief, Division of General Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan Wisnivesky, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Albert Einstein College of Medicine/Yeshiva University

The Bronx, New York, United States

Site Status

Jacobi Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01HL131418

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 15-0667

Identifier Type: -

Identifier Source: org_study_id

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