NCT03646669

Symptom Perception

Completed NA Results posted Last updated 6 May 2023

What this trial tests

NA trial testing PEF Feedback in Asthma in 58 participants. Completed in 1 April 2022.

Timeline

15 February 2019

Primary endpoint
1 April 2022

1 April 2022

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	58
Start date	15 February 2019
Primary completion	1 April 2022
Estimated completion	1 April 2022
Sites	3 locations across United States

Drugs / interventions tested

• PEF Feedback
• Asthma education

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

60 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Asthma Control Questionnaire (ACQ) Primary · 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

Baseline

Group	Value	95% CI
Asthma Education and PEF Feedback	1.2	± 1.1
Asthma Education	1.4	± 1.0

1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	0.8	± 0.8
Asthma Education	1.4	± 0.8

1 month follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	0.6	± 0.5
Asthma Education	1.6	± 0.9

Change in Asthma Quality of Life Questionnaire (AQLQ) Primary · 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.

Baseline

Group	Value	95% CI
Asthma Education and PEF Feedback	5.2	± 1.2
Asthma Education	5.0	± 1.0

1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	5.6	± 1.4
Asthma Education	4.9	± 1.1

1 month follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	5.7	± 1.1
Asthma Education	5.0	± 1.1

Change in Medication Adherence Rating Scale (MARS) Secondary · Baseline, 1 week follow up, 1 month follow up

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

Baseline

Group	Value	95% CI
Asthma Education and PEF Feedback	4.0	± 1.0
Asthma Education	4.2	± 0.8

1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	4.4	± 0.7
Asthma Education	4.3	± 0.8

1 month follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	4.2	± 0.6
Asthma Education	4.4	± 0.6

Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score Secondary · Baseline, 1 week follow up, 1 month follow up

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.

Necessity Baseline

Group	Value	95% CI
Asthma Education and PEF Feedback	17.4	± 4.9
Asthma Education	18.2	± 4.4

Necessity 1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	18.9	± 4.3
Asthma Education	17.2	± 4.5

Necessity 1 month follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	18.4	± 4.5
Asthma Education	18.1	± 5.2

Concerns Baseline

Group	Value	95% CI
Asthma Education and PEF Feedback	14.2	± 4.2
Asthma Education	14.5	± 4.0

Concerns 1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	13.0	± 4.4
Asthma Education	12.9	± 4.5

Concerns 1 month follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	13.6	± 4.2
Asthma Education	12.8	± 4.0

Change in Beliefs About Illness Perception Questionnaire (BIPQ) Secondary · Baseline, 1 week follow up

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

Group	Value	95% CI
Asthma Education and PEF Feedback	33.3	± 13.9
Asthma Education	34.0	± 0.7

1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	30.7	± 13.9
Asthma Education	34.7	± 11.8

Symptom Perception Measures Adjusted Secondary · Baseline, 1 week follow up, 1 month follow up

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

Symptom Accurate Perception Baseline

Group	Value	95% CI
Asthma Education and PEF Feedback	55.3	± 6.5
Asthma Education	51.1	± 6.9

Symptom Accurate Perception 1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	71.5	± 6.3
Asthma Education	52.7	± 6.4

Symptom Accurate Perception 1 month follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	72.2	± 7.6
Asthma Education	42.9	± 8.3

Symptom Under-Perception Baseline

Group	Value	95% CI
Asthma Education and PEF Feedback	39.7	± 7
Asthma Education	44.9	± 7.5

Symptom Under-Perception 1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	11.9	± 6.4
Asthma Education	33.8	± 6.4

Symptom Under-Perception 1 month follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	11.8	± 7.4
Asthma Education	45.1	± 8.0

Symptom Over-Perception Baseline

Group	Value	95% CI
Asthma Education and PEF Feedback	5.0	± 2.1
Asthma Education	3.9	± 2.3

Symptom Over-Perception 1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	16.6	± 4.9
Asthma Education	13.6	± 5

Asthma Control Questionnaire (ACQ) Score - Adjusted Secondary · 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 adjusted for age, sex, race, monthly income

Baseline

Group	Value	95% CI
Asthma Education and PEF Feedback	1.4	± 0.2
Asthma Education	1.5	± 0.2

1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	0.9	± 0.4
Asthma Education	1.1	± 0.4

1 month follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	0.7	± 0.3
Asthma Education	1.3	± 0.3

Treatment Credibility Secondary · 1 week follow up, 1 month follow up

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

1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	19.3	± 1.7
Asthma Education	19.2	± 1.5

1 month follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	19.2	± 1.4
Asthma Education	18.9	± 3.7

Treatment Expectancy Secondary · 1 week follow up, 1 month follow up

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

1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	25.3	± 4.6
Asthma Education	25.2	± 2.7

1 month follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	25.3	± 4.8
Asthma Education	21.9	± 8.9

Change in Medication Adherence Rating Scale (MARS) Adjusted Secondary · Baseline, 1 week follow up, 1 month follow up

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

Group	Value	95% CI
Asthma Education and PEF Feedback	4.0	± 0.2
Asthma Education	4.3	± 0.2

1 week follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	4.4	± 0.2
Asthma Education	4.2	± 0.2

1 month follow up

Group	Value	95% CI
Asthma Education and PEF Feedback	4.1	± 0.1
Asthma Education	4.4	± 0.2

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.