Symptom Perception

NCT03646669 | Completed Results

• 2 other identifiers: GCO 15-0667R01HL131418
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 3

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.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Change in Medication Adherence Rating Scale (MARS)

  Baseline, 1 week follow up, 1 month follow up

• Change in Beliefs About Medicines Questionnaire (BMQ) - Necessity Score and Concerns Score

  Baseline, 1 week follow up, 1 month follow up

• Change in Beliefs About Illness Perception Questionnaire (BIPQ)

  Baseline, 1 week follow up

• Symptom Perception Measures Adjusted

  Baseline, 1 week follow up, 1 month follow up

• Asthma Control Questionnaire (ACQ) Score - Adjusted

  Baseline, 1 week follow up, 1 month follow up

Study Arms (2)

Asthma education and PEF feedback

EXPERIMENTAL

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

Behavioral: PEF Feedback

Asthma education

PLACEBO COMPARATOR

No PEF feedback arm

Behavioral: Asthma education

Interventions

PEF Feedback 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.

Also known as: Intervention Arm

Asthma education and PEF feedback

Asthma education 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.

Asthma education

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥60 years
• English or Spanish speaking
• Asthma diagnosis made by a health care provider

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Albert Einstein College of Medicine: collaborator
• Jacobi Medical Center: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Albert Einstein College of Medicine/Yeshiva University

The Bronx, New York, 10461, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Asthma; Medication Adherence

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Maria Peralta
• Organization: Icahn School of Medicine at Mount Sinai

Maria.peralta@mountsinai.org

212-274-7571

Study Officials

• Juan Wisnivesky, MD, MPH

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Chief, Division of General Internal Medicine

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: February 15, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 6, 2023
• Results First Posted: May 6, 2023

Record last verified: 2023-05

Locations

US (3)