Symptom Perception

Asthma Clinical Trial

Official title:

Symptom Perception, Behavior, and Outcomes in Older Asthmatics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646669
• Other study ID #: GCO 15-0667
• Secondary ID: R01HL131418
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: May 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine/Yeshiva University	Bronx	New York
United States	Jacobi Medical Center	Bronx	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Albert Einstein College of Medicine, Jacobi Medical Center, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 1 week follow up, 1 month follow up
Primary	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.	Baseline, 1 week follow up, 1 month follow up
Secondary	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.	Baseline, 1 week follow up, 1 month follow up
Secondary	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 ?ve-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.	Baseline, 1 week follow up, 1 month follow up
Secondary	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.	Baseline, 1 week follow up
Secondary	Symptom Perception Measures Adjusted	Assessed based on alignment of patient guesses and actual PEF values recorded by the AM2 device and then categorizing into accurate, under or over-perception, adjusted for age, sex, race, monthly income Assesses if training and feedback can improve under perception of airflow obstruction and lead to better control in older adults with asthma	Baseline, 1 week follow up, 1 month follow up
Secondary	Asthma Control Questionnaire (ACQ) Score - Adjusted	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 adjusted for age, sex, race, monthly income	Baseline, 1 week follow up, 1 month follow up
Secondary	Treatment Credibility	Treatment Credibility adjusted for age, sex, race, monthly income; The credibility of a treatment rationale consists of "how believable, convincing, and logical the treatment is". The CEQ credibility factor, reflecting a cognitively-based process, is based on patients' summed responses to three items measuring how logical the therapy seems, how successful one thinks it will be in reducing symptoms, and how confident one would be in recommending it to a friend with similar symptoms. The modified version used in this study included items rated on 7 point scales ranging from 1 (Not at all logical/successful /confident) to 7 (Very logical/successful /confident), with a total score possible range of 3 to 21. Higher scores indicate higher treatment credibility.	1 week follow up, 1 month follow up
Secondary	Treatment Expectancy	Treatment Expectancy adjusted for age, sex, race, monthly income.; Outcome expectancy consists of patients' beliefs about how likely they are to benefit from a treatment.; The CEQ expectancy factor, reflecting an affectively-based process, is based on patients' responses to three items reflecting how much they think they will improve by the end of treatment, how much they feel therapy will help reduce their symptoms, and how much they feel they will improve by the end of treatment. Because one item is on the same 7-point scale as the credibility items and two are assessed on an 11-point scale (from 0% to 100% in 10-point increments), responses are first standardized before summing to render the expectancy total score. The total score possible range is 3 to 33. Higher scores indicate higher treatment expectancy.	1 week follow up, 1 month follow up
Secondary	Change in Medication Adherence Rating Scale (MARS) Adjusted	MARS is a self-reported questionnaire with the total score range from 0-10 with a higher score indicating better adherence. MARS, adjusted for age, sex, race, monthly income	Baseline, 1 week follow up, 1 month follow up