Mechanistic Effects of Health Coaching to Reduce Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations

NCT03837847 | Completed Results DMC

• 2 other identifiers: 18-0007801K24HL138150-01A1
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers are trying to explore the benefit of Health Coaching on patients with severe symptoms of COPD.

Conditions

COPD; Emphysema

Keywords

Health coaching

Outcome Measures

Primary Outcomes (4)

• Change in Chronic Respiratory Questionnaire (CRQ) Dyspnea Score

  The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 - 7. Higher scores indicate less severity of dyspnea.

  Baseline, 3 months

• Change in Chronic Respiratory Questionnaire (CRQ) Fatigue Score

  The CRQ-Fatigue is a 4-item questionnaire that assesses fatigue on a Likert scale from 1 - 7. Higher scores indicate less severity of fatigue.

  Baseline, 3 months

• Change in Chronic Respiratory Questionnaire (CRQ) Mastery Score

  The CRQ-Mastery is a 4-item questionnaire that assesses mastery on a Likert scale from 1 - 7. Higher scores indicate a higher level of mastering the ability to deal with the symptoms of the disease.

  Baseline, 3 months

• Change in Chronic Respiratory Questionnaire (CRQ) Emotions Score

  The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 - 7. Higher scores indicate less severity of emotions.

  Baseline, 3 months

Secondary Outcomes (6)

• Change in Daily Physical Activity

  Baseline,3 months

• Change in Self Management

  Baseline, 3 months

• Change in Meaning in Life Questionnaire (MLQ) - Presence of Meaning

  Baseline, 3 months

• Change in Meaning in Life Questionnaire (MLQ) - Search for Meaning

  Baseline, 3 months

• Change in Depression

  Baseline, 3 months

Study Arms (2)

Health Coaching

EXPERIMENTAL

Participants in this group will receive health coaching calls

Behavioral: Health Coaching Calls

Control group

ACTIVE COMPARATOR

Participants in this group will receive 6 educational guides

Behavioral: Control

Interventions

Health Coaching Calls BEHAVIORAL

Participants in this group will receive 12 weekly health coaching calls

Health Coaching

Control BEHAVIORAL

Participants in this group will receive 6 educational guides

Control group

Eligibility Criteria

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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

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: Roberto P. Benzo, M.D.
• Organization: Mayo Clinic

Benzo.Roberto@mayo.edu

507-284-0561

Study Officials

• Roberto P Benzo

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to blind the participants or the study team as subjects will know if they are receiving a health coaching call.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Control wait design

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: February 12, 2019
• Study Start: July 5, 2018
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: July 11, 2024
• Results First Posted: July 11, 2024

Record last verified: 2024-07

Locations

US (1)