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Behavioural Intervention

Telehealth Lifestyle and Exercise for COPD and OSA (FOCuSEd Trial)

N/A

Recruiting

Research Sponsored by Seattle Institute for Biomedical and Clinical Research

Eligibility Criteria Checklist

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

Must have

Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)

COPD: Defined by presence of airflow obstruction (FEV1/FVC < 0.70) on post-bronchodilator spirometry

Must not have

Self-report of weight change >15 lbs. during prior 3 months

Severe illness from any cause

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a telehealth program for 400 overweight and obese patients with COPD and OSA. Participants will be split into two groups, one receiving the telehealth intervention and the other receiving

Who is the study for?

This trial is for overweight and obese patients with both COPD (Chronic Obstructive Pulmonary Disease) and OSA (Obstructive Sleep Apnea), receiving care at selected VA medical centers. Participants should be eligible for primary care services, but specific inclusion and exclusion criteria details are not provided.

What is being tested?

The study tests a telehealth intervention against 'enhanced' usual care in improving quality of life for those with COPD and OSA. The intervention includes a lifestyle program, supervised pulmonary rehab, and potential weight management medications. Usual care prompts referrals to existing programs.

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information. However, as this involves lifestyle changes and exercise interventions rather than medication or invasive procedures, fewer direct side effects may be expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with obstructive sleep apnea.

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I have COPD confirmed by a specific lung function test.

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I experience shortness of breath when moving.

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I have smoked the equivalent of 10 packs of cigarettes a year or more.

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I am 40 years old or older.

Exclusion Criteria

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

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I have lost or gained more than 15 lbs in the last 3 months.

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I am suffering from a severe illness.

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I cannot complete surveys in English.

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I have severe health issues that could make it unsafe for me to join.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The SF-12 PCS

Secondary study objectives

COPD Assessment Test (CAT)

COPD exacerbation or death

Cardiovascular risk score

+10 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: FOCuSEd InterventionActive Control1 Intervention

Participants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation.

Group II: Usual Care- EnhancedActive Control1 Intervention

For participants in the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs.

0 / 9Eligibility criteria met