Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations

COPD Clinical Trial

Official title:

Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837847
• Other study ID #: 18-000780
• Secondary ID: 1K24HL138150-01A
• Status: Completed
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: June 14, 2023

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Emphysema

Intervention

Behavioral:
• Health Coaching Calls
12 weekly health coaching calls
• Wait list control
after being 12 week in the usual care arm , patient will compassionately be offered the health coaching intervention

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related Quality of life	Chronic Respiratory questionnaire	Baseline and 3 months
Secondary	Health care utilization (hospitalization or ED visits)	COPD exacerbations	Baseline and 3 months
Secondary	Daily Physical activity	Actigraph monitor	Baseline and 3 months
Secondary	Self Management	Self Management Ability Scale-30 item questionnaire measuring ability and function. Score range is 0-100, higher score is best.	Baseline and 3 months
Secondary	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.	Baseline and 3 months
Secondary	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.	Baseline and 3 months
Secondary	Anxiety	GAD-2 item questionnaire that screens for anxiety. Scores range from 0-6, a higher score suggests that anxiety may be present.	Baseline and 3 months