~91 spots leftby Jun 2028

Mindful Steps for COPD and Heart Failure

Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Beth Israel Deaconess Medical Center
No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this fully-remote randomized controlled trial is to test the efficacy of Mindful Steps in facilitating physical activity compared to usual standard of care among 136 patients with COPD and/or HF. The main question it aims to answer is can this intervention promote physical activity as measured by daily step counts in sedentary patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive either the Mindful Steps intervention or usual care for 12 months, with both arms receiving a Walking for Health education booklet.

Research Team

Eligibility Criteria

This trial is for patients with COPD or heart failure who can exercise, have an email and a device to use the Fitbit app. They need medical clearance and must not be in rehab or have had recent exacerbations.

Inclusion Criteria

I have been diagnosed with COPD or heart failure based on specific criteria.
Medical clearance from provider to participate in an exercise program
Have an active email account; access to a computer device (desktop, laptop, tablet, or smartphone that supports the Fitbit app)

Exclusion Criteria

I can't provide 2 weeks of my daily step counts.
I have had a worsening of my COPD or heart failure in the last month.
I am currently in a heart or lung rehab program.
See 1 more

Treatment Details

Interventions

  • Mindful Steps (Behavioural Intervention)
Trial OverviewThe study tests Mindful Steps, aiming to increase physical activity over 12 months compared to usual care. Participants are randomly assigned to either the intervention or control group, both receiving a health booklet.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindful StepsExperimental Treatment1 Intervention
Multi-modal web intervention including: pedometer with individualized step-count goals, motivational and educational content, online community forum, mind-body videos (short themed clips that support walking, plus library of mind-body exercises), online group mind-body exercise classes, star incentive system; educational booklet
Group II: Usual CareActive Control1 Intervention
Pragmatic usual care (standard care through participant's healthcare provider including pharmacological treatment and general advice for physical activity); educational booklet

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
BIDMCBoston, MA
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Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Patients Recruited
12,930,000+

VA Boston Healthcare System

Collaborator

Trials
73
Patients Recruited
971,000+

University of Michigan

Collaborator

Trials
1891
Patients Recruited
6,458,000+

Brigham and Women's Hospital

Collaborator

Trials
1694
Patients Recruited
14,790,000+

References