AsthmaNCT03646669
Symptom Perception
A study testing PEF Feedback and Asthma education in people with Asthma, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- PEF Feedback and Asthma education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Feb 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60 years
- English or Spanish speaking
- Asthma diagnosis made by a health care provider
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Albert Einstein College of Medicine/Yeshiva University
The Bronx, New York, 10461
Jacobi Medical Center
The Bronx, New York, 10461
About this study
Official title: Symptom Perception, Behavior, and Outcomes in Older Asthmatics
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- PEF Feedback, Asthma education
- Keywords
- Older adults, Asthma, Symptom perception, Self-management behaviors, Medication adherence
- Medical subject headings
- Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEF FeedbackBehavioural
Also called Intervention Arm
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 educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Asthma education and PEF feedback | Experimental | Patients receive asthma education and personal Peak expiratory flow (PEF) feedback Receives: Behavioral: PEF Feedback |
| Asthma education | Placebo comparator | No PEF feedback arm Receives: Behavioral: Asthma education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, 1 week follow up, 1 month follow up
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 week follow up
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
Measured: Baseline, 1 week follow up, 1 month follow up
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
Measured: Baseline, 1 week follow up, 1 month follow up
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.
Measured: 1 week follow up, 1 month follow up
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.
Measured: 1 week follow up, 1 month follow up
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
Measured: Baseline, 1 week follow up, 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start15 Feb 2019
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Jacobi Medical Center, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Juan P Wisnivesky, Icahn School of Medicine at Mount Sinai
- Investigators
- Juan Wisnivesky, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646669
- Sponsor's protocol ID
- GCO 15-0667
- Other IDs
- R01HL131418
- Status last verified
- May 2023
- First submitted
- 22 Aug 2018
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Perception, Behavior, and Outcomes in Older Asthmatics
- ClinicalTrials.gov ID
- NCT03646669
- Acronym / sponsor ID
- GCO 15-0667
- Conditions
- Asthma
- Keywords
- Older adults, Asthma, Symptom perception, Self-management behaviors, Medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine, Jacobi Medical Center, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma education and PEF feedback | Experimental | Behavioral: PEF FeedbackPatients receive asthma education and personal Peak expiratory flow (PEF) feedback |
| Asthma education | Placebo comparator | Behavioral: Asthma educationNo PEF feedback arm |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥60 years
- English or Spanish speaking
- Asthma diagnosis made by a health care provider
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEF FeedbackAlso: Intervention ArmPatients 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. | Behavioural | Asthma education and PEF feedback |
| Asthma educationGeneral 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. | Behavioural | Asthma education |
Primary outcome
Asthma Control Questionnaire (ACQ)
Time frame: Baseline, 1 week follow up, 1 month follow up
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
Change in Asthma Quality of Life Questionnaire (AQLQ)
Time frame: Baseline, 1 week follow up, 1 month follow up
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.
8 secondary outcomes
Change in Medication Adherence Rating Scale (MARS)
Time frame: Baseline, 1 week follow up, 1 month follow up
Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score
Time frame: Baseline, 1 week follow up, 1 month follow up
Change in Beliefs About Illness Perception Questionnaire (BIPQ)
Time frame: Baseline, 1 week follow up
Symptom Perception Measures Adjusted
Time frame: Baseline, 1 week follow up, 1 month follow up
Asthma Control Questionnaire (ACQ) Score - Adjusted
Time frame: Baseline, 1 week follow up, 1 month follow up
Treatment Credibility
Time frame: 1 week follow up, 1 month follow up
Treatment Expectancy
Time frame: 1 week follow up, 1 month follow up
Change in Medication Adherence Rating Scale (MARS) Adjusted
Time frame: Baseline, 1 week follow up, 1 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Wisnivesky, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEF Feedback and Asthma education in people with Asthma, run by Icahn School of Medicine at Mount Sinai at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Questionnaire (ACQ) (time frame: Baseline, 1 week follow up, 1 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.