Comprehensive Self-management Support for COPD Patients

NCT04533412 | Completed Results DMC

• 2 other identifiers: GCO 17-2407R34HL143747
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The study team will adapt and expand an effective model of asthma self-management support for patients with chronic obstructive pulmonary disease (COPD). In this new model, community health workers will comprehensively screen for and address barriers to effective COPD self-management, including maladaptive coping behaviors, and guide patients through home-based pulmonary rehabilitation. Feasibility of the new model will be assessed in preparation for a fully powered, multisite randomized trial.

Conditions

COPD; Self-management Behaviors

Keywords

chronic obstructive pulmonary disease; pulmonary rehabilitation; intervention; home-based; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• COPD Assessment Test (CAT)

  The COPD Assessment Test (CAT) is a validated measure designed to measure the impact of COPD on a person's life, and how this changes over time. Full range from 0-40, higher scores indicates a more severe impact of COPD on a patient's life.

  Baseline and 6 months

Secondary Outcomes (6)

• Number of Participants With Medication Adherence Report Scale (MARS) Score ≥4.5

  Baseline and 6 months

• Exercise Tolerance - 6 Minute Walk Test

  Baseline and 6 months

• Physical Activity Adult Questionnaire (PAAQ)

  Baseline and 6 months

• Number of Participants With Hospitalizations

  Baseline and 6 months

• Number of Participants With ED Visits

  Baseline and 6 months

Study Arms (2)

Targeted self-management barrier support

EXPERIMENTAL

Intervention group - Targeted self-management barrier support, home-based pulmonary rehabilitation, and emergency medication with community health workers

Behavioral: Self-management barrier support

Guided COPD education

ACTIVE COMPARATOR

Control group - Guided COPD education with a COPD educator

Behavioral: Basic COPD Education

Interventions

Self-management barrier support BEHAVIORAL

For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.

Targeted self-management barrier support

Basic COPD Education BEHAVIORAL

The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.

Guided COPD education

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>40 years
• Chart-document severe or very severe COPD (FEV1\<50% predicted) or COPD-related ED/hospitalization ≥ 1 visit within the past 12 months
• Prescribed any daily medication for COPD, English or Spanish speaking, Smoking history ≥ 10 pack-years

You may not qualify if:

• Diagnosis in the clinical record of dementia, because the study focuses on patients with capacity to independently perform self-management tasks.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• City Health Works: collaborator
• Northwestern University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (3)

• Federman AD, Barry M, Moas E, Davenport C, McGeough C, Tejeda M, Rivera L, Gutierrez S, Mejias H, Belton D, Mathew C, Lindenauer PK, McDermott D, O'Conor R, Wolf MS, Wisnivesky JP. Protocol for a feasibility randomized trial of self-management support for people with chronic obstructive pulmonary disease using lay health coaches. Contemp Clin Trials. 2021 Nov;110:106570. doi: 10.1016/j.cct.2021.106570. Epub 2021 Sep 21.

  PMID: 34560265 DERIVED

• Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.

  PMID: 34495549 DERIVED

• Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

  PMID: 33511633 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alex D. Federman, MD, MPH
• Organization: Icahn School of Medicine at Mount Sinai

alex.federman@mountsinai.org

(212) 824-7565

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research coordinators (RCs) and investigators are blinded to study randomization and treatment arm for each participant.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations. The attention control is designed to isolate the impact of screening for self-management barriers. The attention control will consist of 4 visits by a COPD educator who will review a COPD education booklet. Participants are randomized based on COPD Assessment Test (CAT) scores: CAT \<10 vs CAT \>10

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: August 31, 2020
• Study Start: August 24, 2020
• Primary Completion: April 28, 2022
• Study Completion: April 28, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)