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OpenTrials
Completed

NCT Number: NCT03837847

Mechanistic Effects of Health Coaching to Reduce Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations

The researchers are trying to explore the benefit of Health Coaching on patients with severe symptoms of COPD.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health coaching calls

Behavioral

Participants in this group will receive 12 weekly health coaching calls

Control

Behavioral

Participants in this group will receive 6 educational guides

Primary outcomes

  1. Change in Chronic Respiratory Questionnaire (CRQ) Dyspnea Score

    Time frame: Baseline, 3 months

    The CRQ-Dyspnea is a 5-item questionnaire that assesses dyspnea on a Likert scale from 1 - 7. Higher scores indicate less severity of dyspnea.

  2. Change in Chronic Respiratory Questionnaire (CRQ) Fatigue Score

    Time frame: Baseline, 3 months

    The CRQ-Fatigue is a 4-item questionnaire that assesses fatigue on a Likert scale from 1 - 7. Higher scores indicate less severity of fatigue.

  3. Change in Chronic Respiratory Questionnaire (CRQ) Mastery Score

    Time frame: Baseline, 3 months

    The CRQ-Mastery is a 4-item questionnaire that assesses mastery on a Likert scale from 1 - 7. Higher scores indicate a higher level of mastering the ability to deal with the symptoms of the disease.

  4. Change in Chronic Respiratory Questionnaire (CRQ) Emotions Score

    Time frame: Baseline, 3 months

    The CRQ-Emotions is a 7-item questionnaire that assesses emotions on a Likert scale from 1 - 7. Higher scores indicate less severity of emotions.

Secondary outcomes

  1. Change in Daily Physical Activity

    Time frame: Baseline,3 months

    Mean change in the number of steps per day

  2. Change in Self Management

    Time frame: Baseline, 3 months

    Self-Management Ability Scale-30 item questionnaire measuring ability and function. Total score range is 0-100, higher score indicated better ability and function.

  3. Change in Meaning in Life Questionnaire (MLQ) - Presence of Meaning

    Time frame: Baseline, 3 months

    The MLQ is a 10-item questionnaire that assesses quality of life rated on a seven-point scale from 1 = Absolutely Untrue to 7 =Absolutely True. The Presence of Meaning subscale score = subtract the rating for item #9 from 8, then add to the ratings for items 1, 4, 5, and 6. Total Presence of Meaning Scores range between 5 and 35. Higher scores indicate more fullness of meaning a person feels in their life.

  4. Change in Meaning in Life Questionnaire (MLQ) - Search for Meaning

    Time frame: Baseline, 3 months

    The MLQ is a 10-item questionnaire that assesses quality of life rated on a seven-point scale from 1 = Absolutely Untrue to 7 =Absolutely True. The Search for Meaning subscale score = add together the ratings for items 2, 3, 7, 8, and 10. Total Search for Meaning scores range between 5 and 35. Higher scores indicate more engaged and motivated a person feels to understand and find meaning in their life

  5. Change in Depression

    Time frame: Baseline, 3 months

    The Patient Health Questionnaire 9-item (PHQ-9) scale used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.

  6. Change in Anxiety

    Time frame: Baseline,3 months

    The General Anxiety Disorder 2-item (GAD 2) scale assess severity of generalized anxiety disorder. Total scores range from 0-6, a higher score indicates greater anxiety.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2019
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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