Symptom Perception

• ClinicalTrials.gov Identifier: NCT03646669
• Recruitment Status: Enrolling by invitation
• First Posted: August 24, 2018
• Last Update Posted: March 2, 2021
• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Albert Einstein College of Medicine; Jacobi Medical Center; National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Juan P Wisnivesky, Icahn School of Medicine at Mount Sinai

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Behavioral: PEF Feedback; Behavioral: Asthma education	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Symptom Perception, Behavior, and Outcomes in Older Asthmatics
• Actual Study Start Date: February 15, 2019
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: April 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Asthma education and PEF feedback; Patients receive asthma education and personal Peak expiratory flow (PEF) feedback	Behavioral: 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.; Other Name: Intervention Arm
Placebo Comparator: Asthma education; No PEF feedback arm	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.

Outcome Measures

Primary Outcome Measures :

1. Change in Beliefs about Illness Perception Questionnaire (BIPQ) [ Time Frame: 1 months after intervention ]
   BIPQ includes 9 items for each of the 5 cognitive domains designed to rapidly assess the cognitive and emotional representations of illness. Each item is scored on a 0 (none) to 10 (extreme). Items on the BIPQ are not meant to be summed, but rather evaluated and interpreted individually.
2. Change in Beliefs about Illness Perception Questionnaire (BIPQ) [ Time Frame: 2 months after intervention ]
   BIPQ includes 9 items for each of the 5 cognitive domains designed to rapidly assess the cognitive and emotional representations of illness. Each item is scored on a 0 (none) to 10 (extreme). Items on the BIPQ are not meant to be summed, but rather evaluated and interpreted individually.

Secondary Outcome Measures :

1. Change in PEF [ Time Frame: 1 month after intervention ]
   Assessed based on alignment of patient guesses and actual PEF values recorded by the AM2 device.
2. Change in PEF [ Time Frame: 2 months after intervention ]
   Assessed based on alignment of patient guesses and actual PEF values recorded by the AM2 device.
3. Change in Beliefs about Medicines Questionnaire (BMQ) [ Time Frame: 1 month after intervention ]
   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 5 to 50, with higher scores indicate stronger beliefs about the corresponding concepts.
4. Change in Beliefs about Medicines Questionnaire (BMQ) [ Time Frame: 2 months after intervention ]
   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 5 to 50, with higher scores indicate stronger beliefs about the corresponding concepts.
5. Change in Medication Adherence Rating Scale (MARS) [ Time Frame: 1 month after intervention ]
   MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence.
6. Change in Medication Adherence Rating Scale (MARS) [ Time Frame: 2 months after intervention ]
   MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence.

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

Albert Einstein College of Medicine/Yeshiva University

Bronx, New York, United States, 10461

Jacobi Medical Center

Bronx, New York, United States, 10461

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Albert Einstein College of Medicine

Jacobi Medical Center

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Juan Wisnivesky, MD, MPH; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: Juan P Wisnivesky, Professor of Medicine and Chief, Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03646669
• Other Study ID Numbers: GCO 15-0667; R01HL131418 ( U.S. NIH Grant/Contract )
• First Posted: August 24, 2018
• Last Update Posted: March 2, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juan P Wisnivesky, Icahn School of Medicine at Mount Sinai:

Older adults; Asthma; Symptom perception; Self-management behaviors; Medication adherence

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases