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Behavioural Intervention

Mindful Steps for COPD and Heart Failure

N/A

Waitlist Available

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Inability to collect at least 7 of 14 days of baseline step counts

Current participation in a cardiac or pulmonary rehabilitation program

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, months 3, 6, 12 and 15

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an intervention called Mindful Steps can help COPD/HF patients to be more physically active, measured by step counts over 12 months. Participants will receive either Mindful Steps or usual care.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since this trial involves a mindfulness-based intervention rather than medication, side effects may include discomfort from increased physical activity but no drug-related side effects.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can't provide 2 weeks of my daily step counts.

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I am currently in a heart or lung rehab program.

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I cannot walk on my own.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, months 3, 6, 12 and 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, months 3, 6, 12 and 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, months 3, 6, 12 and 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in physical activity

Secondary study objectives

Change in disease-specific quality-of-life

Change in dyspnea

Change in exercise engagement

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindful Steps

2019

N/A

~50

0 / 3Eligibility criteria met