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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03837847
Other study ID # 18-000780
Secondary ID 1K24HL138150-01A
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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