Telehealth Lifestyle and Exercise for COPD and OSA

(FOCuSEd Trial)

Recruiting at 4 trial locations

Overseen By Brianna Moss

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Institute for Biomedical and Clinical Research

Must not be taking: Weight loss medications

Disqualifiers: Severe illness, Bulimia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. \< 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to 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. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on prescription weight loss medication, you must not have taken it in the last 3 months to be eligible.

What data supports the effectiveness of the FOCuSEd Integrated Intervention treatment for COPD and OSA?

Research shows that using telehealth technology to deliver exercise therapy at home can be effective for people with COPD, as it helps them stay active and manage their condition better than not exercising or traditional methods. However, maintaining physical activity levels long-term without supervision can be challenging. ^{1 2 3 4 5}

Is the Telehealth Lifestyle and Exercise Intervention safe for humans?

The studies reviewed do not report any significant safety concerns for telehealth-based exercise and lifestyle interventions in people with chronic obstructive pulmonary disease (COPD). These interventions generally focus on increasing physical activity and managing symptoms, which are considered safe for most individuals with COPD. ^{1 2 5 6 7}

How is the FOCuSEd Integrated Intervention treatment different from other treatments for COPD and OSA?

The FOCuSEd Integrated Intervention is unique because it combines telehealth technology with lifestyle and exercise coaching to improve physical activity in patients with COPD and OSA, making it more accessible and personalized compared to traditional in-person rehabilitation programs. ^{1 2 3 8 9}

Eligibility Criteria

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.

Inclusion Criteria

I experience shortness of breath when moving.

I have been diagnosed with obstructive sleep apnea.

I have COPD confirmed by a specific lung function test.

Exclusion Criteria

Active enrollment in pulmonary rehabilitation

Participation in other intervention studies

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation

3 months

Regular virtual visits

Post-core period

Participants continue to have as-needed access to the lifestyle coach

9 months

As-needed virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Virtual visits at 3 and 12 months

Treatment Details

Interventions

• FOCuSEd Integrated Intervention

Trial Overview 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.

Participant Groups

Group I: FOCuSEd Intervention Active Control 1 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- Enhanced Active Control 1 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.

Who Is Running the Clinical Trial?

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

Trials

55

Recruited

13,700+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

Home-based exercise therapy using advanced telehealth technology (ATT-ET) significantly improves exercise capacity, quality of life, and functional dyspnoea in people with chronic obstructive pulmonary disease (COPD) compared to no exercise therapy, based on a systematic review of 15 trials with 1,522 participants.

ATT-ET shows similar or better effects on quality of life and functional dyspnoea compared to both in/outpatient exercise therapy and home-based exercise therapy without telehealth, indicating its effectiveness as a viable alternative for managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced telehealth technology improves home-based exercise therapy for people with stable chronic obstructive pulmonary disease: a systematic review. Bonnevie, T., Smondack, P., Elkins, M., et al.[2022]

Both traditional exercise therapy (TET) and a behavioral lifestyle activity program (LAP) effectively increased moderate physical activity levels in COPD patients over a 12-month period, with no significant differences between the two approaches.

The study involved 176 COPD patients and assessed their physical activity levels at multiple time points, showing that both interventions led to similar improvements in activity levels, indicating that either program can be beneficial for enhancing physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lifestyle activity intervention in patients with chronic obstructive pulmonary disease. Berry, MJ., Rejeski, WJ., Miller, ME., et al.[2021]

The 'Active for Life with COPD' intervention, which included walking and functional training over 10 weeks, was found to be feasible and acceptable for participants, with 26 out of 36 subjects completing the program.

Participants reported an increase in light physical activity, with an average increase of 36 minutes of standing/stepping per day, and they maintained a gain of 21 minutes at a two-month follow-up, suggesting potential for long-term physical activity maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of active for life with COPD, an intervention to increase light physical activity in people with COPD. Larson, JL., Webster, KE.[2021]

A Delphi study involving 73 participants, including people with COPD and experts, identified 81 important items related to improving physical activity, sedentary behavior, and sleep, emphasizing the need for a multifactorial approach to behavior change.

Key themes included symptom management, targeting behavioral factors, and adapting social and physical environments, suggesting that addressing these areas could lead to effective, long-term interventions for individuals with COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving physical activity, sedentary behaviour and sleep in COPD: perspectives of people with COPD and experts via a Delphi approach. Lewthwaite, H., Effing, TW., Lenferink, A., et al.[2022]

After a 2-year telerehabilitation program for COPD, physical activity levels significantly decreased in the following year, dropping from an average of 3,806 steps per day to 2,817 steps per day among nine participants.

Despite the decline in physical activity, other health outcomes such as quality of life, anxiety, and depression remained stable, suggesting that unsupervised home exercise alone may not be sufficient to sustain physical activity levels post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are Physical activity and Benefits Maintained After Long-Term Telerehabilitation in COPD? Hoaas, H., Morseth, B., Holland, AE., et al.[2020]

A patient registry was successfully used to recruit a representative sample of 5582 outpatients with COPD, achieving a participation rate of 35.1% over 30 months for a trial focused on increasing physical activity.

After a 6-week education period, 305 patients were randomized into two groups, showing no significant differences in demographics or health status, indicating that the recruitment method effectively captured a diverse and comparable population for the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): results of recruitment and baseline patient characteristics. Russo, R., Coultas, D., Ashmore, J., et al.[2023]

The study found that telephone health-mentoring for home-based walking (tele-rehab) did not improve exercise capacity in people with COPD compared to usual care, indicating that this approach may not be effective for increasing physical activity levels.

Supervised exercise during pulmonary rehabilitation (PR) was essential for improving physical capacity, as participants who attended these sessions showed some improvement, highlighting the importance of structured exercise in managing COPD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of telephone-mentoring with home-based walking preceding rehabilitation in COPD. Cameron-Tucker, HL., Wood-Baker, R., Joseph, L., et al.[2018]

The 12-week telecoaching intervention for physical activity in COPD patients was well accepted, with 89.3% of participants enjoying the program, indicating high feasibility from both patient and coach perspectives.

While the step counter was used effectively, the smartphone app saw decreased usage over time, and patients needing more contact time experienced less improvement in physical activity, suggesting that tailored support may be necessary for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-Based Physical Activity Telecoaching in Chronic Obstructive Pulmonary Disease: Mixed-Methods Study on Patient Experiences and Lessons for Implementation. Loeckx, M., Rabinovich, RA., Demeyer, H., et al.[2023]

Telehealthcare significantly improves physical activity levels in patients with chronic obstructive pulmonary disease (COPD), with an average increase of 64.7 minutes compared to standard care, based on a systematic review of 9 studies involving 982 patients.

However, telehealthcare did not show significant differences in physical capacity or dyspnea levels, indicating that while it can enhance activity, it may not directly improve other aspects of COPD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. Lundell, S., Holmner, Å., Rehn, B., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Advanced telehealth technology improves home-based exercise therapy for people with stable chronic obstructive pulmonary disease: a systematic review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

A lifestyle activity intervention in patients with chronic obstructive pulmonary disease. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of active for life with COPD, an intervention to increase light physical activity in people with COPD. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Improving physical activity, sedentary behaviour and sleep in COPD: perspectives of people with COPD and experts via a Delphi approach. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Are Physical activity and Benefits Maintained After Long-Term Telerehabilitation in COPD? [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): results of recruitment and baseline patient characteristics. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of telephone-mentoring with home-based walking preceding rehabilitation in COPD. [2018]

8. Canada pubmed.ncbi.nlm.nih.gov

Smartphone-Based Physical Activity Telecoaching in Chronic Obstructive Pulmonary Disease: Mixed-Methods Study on Patient Experiences and Lessons for Implementation. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Telehealthcare in COPD: a systematic review and meta-analysis on physical outcomes and dyspnea. [2022]