Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations

Sponsor

Mayo Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03837847

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

58.8

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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 Behavioral: Wait list control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Control wait designRandomized 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 :

Jul 5, 2018

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

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: Wait list control after being 12 week in the usual care arm , patient will compassionately be offered the health coaching intervention

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: Wait list control

after being 12 week in the usual care arm , patient will compassionately be offered the health coaching intervention

Outcome Measures

Primary Outcome Measures

Health related Quality of life [Baseline and 3 months]
Chronic Respiratory questionnaire

Secondary Outcome Measures

Health care utilization (hospitalization or ED visits) [Baseline and 3 months]
COPD exacerbations
Daily Physical activity [Baseline and 3 months]
Actigraph monitor
Self Management [Baseline and 3 months]
Self Management Ability Scale-30 item questionnaire measuring ability and function. Score range is 0-100, higher score is best.
Meaning in Life [Baseline and 3 months]
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 [Baseline and 3 months]
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 [Baseline and 3 months]
GAD-2 item questionnaire that screens for anxiety. Scores range from 0-6, a higher score suggests that anxiety may be present.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Roberto P Benzo, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Roberto P. Benzo, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03837847

Other Study ID Numbers:

18-000780 (Pilot Study)
1K24HL138150-01A1

First Posted:

Feb 12, 2019

Last Update Posted:

Jul 8, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Roberto P. Benzo, Principal Investigator, Mayo Clinic

Health coaching

Additional relevant MeSH terms:

Emphysema

Study Results

No Results Posted as of Jul 8, 2022