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Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations

Primary Purpose

COPD, Emphysema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Coaching Calls
Wait list control
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Health coaching

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Attention Control

Arm Description

Participants in this group will receive 12 weekly health coaching calls followed by 12 weeks of living a normal life.

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.

Outcomes

Primary Outcome Measures

Health related Quality of life
Chronic Respiratory questionnaire

Secondary Outcome Measures

Health care utilization (hospitalization or ED visits)
COPD exacerbations
Daily Physical activity
Actigraph monitor
Self Management
Self Management Ability Scale-30 item questionnaire measuring ability and function. Score range is 0-100, higher score is best.
Meaning in Life
Meaning in Life MLQ- 10 item questionnaire measures engagement and valued meaning and purpose in life. Scores range from 5-35. The higher the score the more meaning and purpose a person feels in their life.
Patient Health
Patient Health Questionnaire 9 item questionnaire that screens for the presence of depression. Scores range from 0-27, a higher score suggests the presence of depression.
Anxiety
GAD-2 item questionnaire that screens for anxiety. Scores range from 0-6, a higher score suggests that anxiety may be present.

Full Information

First Posted
January 21, 2019
Last Updated
July 10, 2023
Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03837847
Brief Title
Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations
Official Title
Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
June 14, 2023 (Actual)
Study Completion Date
June 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Emphysema
Keywords
Health coaching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized 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.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in this group will receive 12 weekly health coaching calls followed by 12 weeks of living a normal life.
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Coaching Calls
Intervention Description
12 weekly health coaching calls
Intervention Type
Behavioral
Intervention Name(s)
Wait list control
Intervention Description
after being 12 week in the usual care arm , patient will compassionately be offered the health coaching intervention
Primary Outcome Measure Information:
Title
Health related Quality of life
Description
Chronic Respiratory questionnaire
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Health care utilization (hospitalization or ED visits)
Description
COPD exacerbations
Time Frame
Baseline and 3 months
Title
Daily Physical activity
Description
Actigraph monitor
Time Frame
Baseline and 3 months
Title
Self Management
Description
Self Management Ability Scale-30 item questionnaire measuring ability and function. Score range is 0-100, higher score is best.
Time Frame
Baseline and 3 months
Title
Meaning in Life
Description
Meaning in Life MLQ- 10 item questionnaire measures engagement and valued meaning and purpose in life. Scores range from 5-35. The higher the score the more meaning and purpose a person feels in their life.
Time Frame
Baseline and 3 months
Title
Patient Health
Description
Patient Health Questionnaire 9 item questionnaire that screens for the presence of depression. Scores range from 0-27, a higher score suggests the presence of depression.
Time Frame
Baseline and 3 months
Title
Anxiety
Description
GAD-2 item questionnaire that screens for anxiety. Scores range from 0-6, a higher score suggests that anxiety may be present.
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto P Benzo
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations

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