COPDNCT03837847

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

A study testing Health Coaching Calls in people with COPD and Emphysema, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The researchers are trying to explore the benefit of Health Coaching on patients with severe symptoms of COPD. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD, Emphysema
What is being tested?: Health Coaching Calls
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteUnited States
Study dates: 5 Jul 2018to 14 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations

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

Conditions: COPD, Emphysema
Being tested: Health Coaching Calls, Control
Keywords: Health coaching
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Emphysema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Health Coaching CallsBehavioural
Participants in this group will receive 12 weekly health coaching calls
ControlBehavioural
Participants in this group will receive 6 educational guides

Study groups in NCT03837847
Study group	Role	What they receive
Health Coaching	Experimental	Participants in this group will receive health coaching calls Receives: Behavioral: Health Coaching Calls
Control group	Active comparator	Participants in this group will receive 6 educational guides Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Chronic Respiratory Questionnaire (CRQ) Dyspnea Score
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.
Measured: Baseline, 3 months
Change in Chronic Respiratory Questionnaire (CRQ) Fatigue Score
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.
Measured: Baseline, 3 months
Change in Chronic Respiratory Questionnaire (CRQ) Mastery Score
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.
Measured: Baseline, 3 months
Change in Chronic Respiratory Questionnaire (CRQ) Emotions Score
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.
Measured: Baseline, 3 months

Secondary outcomes (6)

Change in Daily Physical Activity
Mean change in the number of steps per day
Measured: Baseline,3 months
Change in Self Management
Self-Management Ability Scale-30 item questionnaire measuring ability and function. Total score range is 0-100, higher score indicated better ability and function.
Measured: Baseline, 3 months
Change in Meaning in Life Questionnaire (MLQ) - Presence of Meaning
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.
Measured: Baseline, 3 months
Change in Meaning in Life Questionnaire (MLQ) - Search for Meaning
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
Measured: Baseline, 3 months
Change in Depression
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.
Measured: Baseline, 3 months
Change in Anxiety
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.
Measured: Baseline,3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 201814 Jun 2023

First posted12 Feb 2019
Study start5 Jul 2018
Primary completion14 Jun 2023
Study completion14 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized Control wait design
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03837847
Sponsor's protocol ID: 18-000780
Other IDs: 1K24HL138150-01A1
Status last verified: Jul 2024
First submitted: 21 Jan 2019
Last updated: 11 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations
ClinicalTrials.gov ID: NCT03837847
Acronym / sponsor ID: 18-000780
Conditions: COPD, Emphysema
Keywords: Health coaching
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: 5 Jul 2018 (actual)
Primary completion: 14 Jun 2023 (actual)
Study completion: 14 Jun 2023 (actual)
First posted: 12 Feb 2019 (actual)
Results: Posted 11 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized Control wait design

Arm	Type	Receives
Health Coaching	Experimental	Behavioral: Health Coaching CallsParticipants in this group will receive health coaching calls
Control group	Active comparator	Behavioral: ControlParticipants in this group will receive 6 educational guides

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Health Coaching CallsParticipants in this group will receive 12 weekly health coaching calls	Behavioural	Health Coaching
ControlParticipants in this group will receive 6 educational guides	Behavioural	Control group

Primary outcome

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.
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.
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.
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.

6 secondary outcomes

Change in Daily Physical Activity
Time frame: Baseline,3 months
Change in Self Management
Time frame: Baseline, 3 months
Change in Meaning in Life Questionnaire (MLQ) - Presence of Meaning
Time frame: Baseline, 3 months
Change in Meaning in Life Questionnaire (MLQ) - Search for Meaning
Time frame: Baseline, 3 months
Change in Depression
Time frame: Baseline, 3 months
Change in Anxiety
Time frame: Baseline,3 months

Results and safety

Results posted to the registry on 11 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	33	33
Health Coaching	30	30

Primary outcome: Change in Chronic Respiratory Questionnaire (CRQ) Dyspnea Score

Time frame: Baseline, 3 months. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Health Coaching n = 22	Control Group n = 24
Value	0.29 (-0.02 to 0.59)	-0.26 (-0.66 to 0.14)

Population analysed: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

Primary outcome: Change in Chronic Respiratory Questionnaire (CRQ) Fatigue Score

Time frame: Baseline, 3 months. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Health Coaching n = 22	Control Group n = 24
Value	0.53 (-0.05 to 1.12)	0.33 (0.04 to 0.7)

Population analysed: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

Primary outcome: Change in Chronic Respiratory Questionnaire (CRQ) Mastery Score

Time frame: Baseline, 3 months. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Health Coaching n = 22	Control Group n = 24
Value	0.4 (-0.22 to 1.02)	0.22 (0.12 to 0.56)

Population analysed: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

Primary outcome: Change in Chronic Respiratory Questionnaire (CRQ) Emotions Score

Time frame: Baseline, 3 months. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Health Coaching n = 22	Control Group n = 24
Value	0.35 (0.06 to 0.76)	0.25 (0.06 to 0.55)

Population analysed: Data was not collected or analyzed for eight Health coaching subjects and nine Control subjects at 3 months

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were collected from baseline to end of study, approximately 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 33 (0%)	0 of 33 (0%)	3 of 33
Health Coaching	0 of 30 (0%)	0 of 30 (0%)	2 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roberto P Benzo principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Health Coaching Calls in people with COPD and Emphysema, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Chronic Respiratory Questionnaire (CRQ) Dyspnea Score (time frame: Baseline, 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03837847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.