Chronic Obstructive Pulmonary DiseaseNCT02557178

Home-Based Health Management of COPD Patients

A study testing health coaching in people with Chronic Obstructive Pulmonary Disease, run by Sara Seifert at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: health coaching
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 1 siteUnited States
Study dates: Sep 2016to Mar 2019
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

Who may be able to join

diagnosis of GOLD stage II, III, or IV COPD
current or previous smoker with at least 10 pack-years of cigarette smoking
be hospitalized for an exacerbation of COPD

Who cannot join

high likelihood of being lost to follow-up or contact
inability to provide good data or follow commands
inability to do mild exercise

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic
Rochester, Minnesota, 55905

Other trials in United States

About this study

Minnesota HealthSolutions Corporation (MHS) proposes to develop and evaluate a program to motivate and monitor people with chronic obstructive pulmonary disease (COPD) to complete home exercise as part of pulmonary rehabilitation (PR). The proposed system has two components: home-based activity monitoring and health coaching. The investigators will conduct a randomized, wait-list controlled clinical study to evaluate the effects of the activity monitoring system and health coaching on quality of life and daily steps.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: health coaching
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

health coachingBehavioural
Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.

Study groups in NCT02557178
Study group	Role	What they receive
Activity Monitor plus Health Coaching	Experimental	Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise. Receives: Behavioral: health coaching
Control	No intervention	Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.

What is being measured

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

Change in Number of Daily Steps Between the Intervention and Control Conditions
Number of daily steps as measured by the SenseWear Pro ArmBand, which is an accepted criterion measure for daily physical activity in adults with Chronic Obstructive Pulmonary Disease.
Measured: Steps measured at baseline (week 1) and week 9
Change in Physical Quality of Life Between the Intervention and Control Conditions
Measure Description: The Chronic Respiratory Disease Questionnaire measures physical and emotional aspects with 20 items in four domains/categories. The two domains/categories used for physical summary were dyspnea and fatigue. The items are assessed numerically on a 7-point modified Likert scale (from 1 to 7). Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. Physical quality of life is obtained by adding the fatigue and dyspnea scores and dividing by two; hence, the score range is from 1 to 7. Higher scores indicate better health-related quality of life. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more.
Measured: Quality of Life measured at baseline (week 1) and week 9

Timeline

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

Sep 2016Mar 2019

First posted23 Sep 2015 (estimated)
Study startSep 2016
Primary completionMar 2019
Study completionMar 2019

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02557178
Sponsor's protocol ID: R44HL114162-02A1
Other IDs: R44HL114162
Status last verified: Feb 2021
First submitted: 3 Mar 2015
Last updated: 24 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Benzo RP, Ridgeway J, Hoult JP, Novotny P, Thomas BE, Lam NM, V Benzo M, Kramer K, Seifert S. Feasibility of a Health Coaching and Home-Based Rehabilitation Intervention With Remote Monitoring for COPD. Respir Care. 2021 Jun;66(6):960-971. doi: 10.4187/respcare.08580. Epub 2021 Apr 27.
PubMed 33906954

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
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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
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Home-Based Health Management of COPD Patients
ClinicalTrials.gov ID: NCT02557178
Acronym / sponsor ID: R44HL114162-02A1
Conditions: Chronic Obstructive Pulmonary Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Sara SeifertIndustry (pharma, biotech, devices)
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Mayo Clinic
Study start: Sep 2016
Primary completion: Mar 2019 (actual)
Study completion: Mar 2019 (actual)
First posted: 23 Sep 2015 (estimated)
Results: Posted 24 Feb 2021

Clinical summary

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Activity Monitor plus Health Coaching	Experimental	Behavioral: health coachingDevice: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen. Participants in the intervention condition (wearing the Actigraph) will also receive supportive health coaching to encourage them to exercise.
Control	No intervention	–Device: Actigraph Participants will wear the device daily during weeks 1, 9, and 17. Daily steps and activity will be measured. It will identify if they complete a prescribed exercise regimen.

Who may qualify

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

Key inclusion criteria (3 listed)

diagnosis of GOLD stage II, III, or IV COPD
current or previous smoker with at least 10 pack-years of cigarette smoking
be hospitalized for an exacerbation of COPD

Key exclusion criteria (3 listed)

high likelihood of being lost to follow-up or contact
inability to provide good data or follow commands
inability to do mild exercise

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 coachingSupportive coaching to encourage compliance with prescribed pulmonary rehabilitation.	Behavioural	Activity Monitor plus Health Coaching

Primary outcome

Change in Number of Daily Steps Between the Intervention and Control Conditions
Time frame: Steps measured at baseline (week 1) and week 9
Number of daily steps as measured by the SenseWear Pro ArmBand, which is an accepted criterion measure for daily physical activity in adults with Chronic Obstructive Pulmonary Disease.
Change in Physical Quality of Life Between the Intervention and Control Conditions
Time frame: Quality of Life measured at baseline (week 1) and week 9
Measure Description: The Chronic Respiratory Disease Questionnaire measures physical and emotional aspects with 20 items in four domains/categories. The two domains/categories used for physical summary were dyspnea and fatigue. The items are assessed numerically on a 7-point modified Likert scale (from 1 to 7). Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. Physical quality of life is obtained by adding the fatigue and dyspnea scores and dividing by two; hence, the score range is from 1 to 7. Higher scores indicate better health-related quality of life. Scores are obtained by adding the scores for the items that make up each category and dividing by the number of items. A minimally important difference is a change in score of 0.5 or more.

Results and safety

Results posted to the registry on 24 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Activity Monitor Plus Health Coaching	72	56
Control	74	63

Primary outcome: Change in Number of Daily Steps Between the Intervention and Control Conditions

Time frame: Steps measured at baseline (week 1) and week 9. Mean (Standard Deviation). Unit: steps

Measure	Activity Monitor Plus Health Coaching n = 56	Control n = 63
Value	-344.8 (1657.7)	-975.8 (2596.3)

Population analysed: Data is provided for 119 participants who completed the study.

Primary outcome: Change in Physical Quality of Life Between the Intervention and Control Conditions

Time frame: Quality of Life measured at baseline (week 1) and week 9. Mean (Standard Deviation). Unit: units on a scale

Measure	Activity Monitor Plus Health Coaching n = 56	Control n = 63
Value	0.2 (1.0)	0.0 (0.7)

Population analysed: Data is provided for 119 participants who completed the study.

Adverse events

Time frame: Adverse events were monitored through the study time frame, an average of 17 weeks per participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Activity Monitor Plus Health Coaching	0 of 72 (0%)	0 of 72 (0%)	0 of 72
Control	0 of 74 (0%)	0 of 74 (0%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33906954Benzo RP, Ridgeway J, Hoult JP, Novotny P, Thomas BE, Lam NM, V Benzo M, Kramer K, Seifert S. Feasibility of a Health Coaching and Home-Based Rehabilitation Intervention With Remote Monitoring for COPD. Respir Care. 2021 Jun;66(6):960-971. doi: 10.4187/respcare.08580. Epub 2021 Apr 27.
Individual participant dataSharing planned: No

Related trials for Chronic Obstructive Pulmonary Disease

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
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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.

Sara Seifert, MPH principal investigator

Minnesota HealthSolutions

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 in people with Chronic Obstructive Pulmonary Disease, run by Sara Seifert 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?

The sponsor lists 3 inclusion and 3 exclusion criteria. 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 24 Feb 2021. 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 24 Feb 2021). 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 Number of Daily Steps Between the Intervention and Control Conditions (time frame: Steps measured at baseline (week 1) and week 9). The study lists 2 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 NCT02557178, which also lists 1 linked publication.

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 24 Feb 2021.