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Trial record 11 of 54 for:    COPD OR COPD OR chronic obstructive pulmonary disease OR chronic bronchitis OR emphysema | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations

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ClinicalTrials.gov Identifier: NCT03837847
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Roberto P. Benzo, Mayo Clinic

Brief Summary:
This pilot study will explore the benefit of Health Coaching on patients with severe symptoms of COPD.

Condition or disease Intervention/treatment Phase
COPD Emphysema Behavioral: Health Coaching Calls Not Applicable

Detailed Description:

Participants will be randomized to either 12 weeks of weekly telephone health coaching calls followed by 12 weeks of living a normal life or 12 weeks of living a normal life (in addition to 6 brief educational guides and 6 non-health related calls), followed by 12 weeks of health coaching over the phone.

Questionnaires and an activity monitor worn for one week will be used at baseline, 3,6 and 12 months.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Control wait design
Masking: None (Open Label)
Masking Description: It is not possible to blind the participants or the study team as subjects will know if they are receiving a health coaching call.
Primary Purpose: Treatment
Official Title: Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Arm Intervention/treatment
Experimental: Intervention
Participants in this group will receive 12 weekly health coaching calls followed by 12 weeks of living a normal life.
Behavioral: Health Coaching Calls
12 weekly health coaching calls

Active Comparator: Attention Control
Participants in this group will receive 6 educational guides and 6 calls to remind them to read the educational guides (over a 12 week period). The participants will then move to 12 weeks of weekly health coaching calls.
Behavioral: Health Coaching Calls
12 weekly health coaching calls




Primary Outcome Measures :
  1. Health related Quality of life [ Time Frame: Baseline and 3 months ]
    Chronic Respiratory questionnaire


Secondary Outcome Measures :
  1. COMPOSITE outcome (hospitalization or ED visits) [ Time Frame: Baseline and 3 months ]
    COPD exacerbations



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Men and women 40 years or older with a clinical diagnosis of COPD with shortness of breath.

Exclusion: terminal illness, inability to communicate by phone


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837847


Contacts
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Contact: Johanna P Hoult, MA 5072931989 hoult.johanna@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Roberto P Benzo Mayo Clinic

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Responsible Party: Roberto P. Benzo, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03837847     History of Changes
Other Study ID Numbers: 18-000780
1K24HL138150-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roberto P. Benzo, Mayo Clinic:
Health coaching
Additional relevant MeSH terms:
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Emphysema
Pathologic Processes