Web-Based Wellness Program for Long COVID

(BLEND Trial)

Overseen By Anne Caretero, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Severe mobility impairment, Severe mental disorders, Pacemakers, Claustrophobia, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an online wellness program called My Viva Plan can improve the well-being of people with long COVID. Long COVID can lead to persistent physical and mental symptoms, and the program emphasizes better nutrition and mindfulness. Participants will either use the program or not, to assess its impact. Individuals who have experienced COVID for over 12 weeks and continue to have symptoms might be suitable candidates, particularly if they are open to lifestyle changes. As an unphased trial, this study provides a unique opportunity for participants to explore lifestyle changes that could enhance their well-being.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this web-based wellness program is safe for long COVID patients?

Research shows that "My Viva Plan," an online wellness program, aims to improve health through better eating habits and mindfulness. Being an online, self-care-focused program, it is generally considered safe.

The program does not involve medication or medical procedures, reducing the risk of serious side effects. Although specific data on "My Viva Plan" is not available, similar wellness programs are usually well-received. Participants can expect minimal risk, mainly related to changes in diet or exercise routines.

Prospective participants in a trial using "My Viva Plan" can feel confident about its safety, as it promotes healthy lifestyle changes rather than medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about My Viva Plan for Long COVID because it offers a holistic, web-based approach that is distinct from traditional medical treatments. While standard care often focuses on medication and physical therapy, My Viva Plan combines nutrition, mental wellness, and lifestyle strategies to tackle the condition comprehensively. This online platform allows for personalized wellness plans, making it accessible and adaptable to individual needs, which could lead to improved quality of life for those suffering from Long COVID.

What evidence suggests that the My Viva Plan is effective for long COVID?

Research has shown that long COVID, also called PASC (post-acute sequelae of SARS-CoV-2), is a condition where symptoms can persist for months after the initial infection. Common symptoms include tiredness, trouble concentrating, and mood changes. Managing these symptoms may involve better eating habits, more physical activity, and emotional support. In this trial, participants in the intervention arm will use the My Viva Plan, an online wellness program designed to improve overall health through personalized self-care, focusing on nutrition and mindfulness. Although specific data on My Viva Plan's effectiveness for long COVID is not available, its approach aligns with recommended strategies for addressing the condition's physical and mental symptoms. Participants in the control arm will not use My Viva Plan. ^{2 4 5 6 7}

Who Is on the Research Team?

Carla Prado, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults over 18 with long COVID, diagnosed more than 12 weeks ago, who have a BMI between 18.5 and 35, and experience mild to moderate symptoms. They must be able to visit the study center and willing to change their lifestyle. Excluded are those with severe mobility or mental health issues, communication barriers, certain medical devices, or without internet access.

Inclusion Criteria

I have long COVID with mild to moderate symptoms.

You are diagnosed with long COVID syndrome and enrolled in the Kaye Edmonton Clinic.

Your body mass index (BMI) is between 18.5 and 35.

Exclusion Criteria

I cannot understand or communicate in English.

You have a fear of being in small, enclosed spaces.

I am unable to travel to the study center due to severe mobility issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention arm use the My Viva Plan® web-based platform for 8 weeks, focusing on nutrition and mindfulness

8 weeks

Baseline and week 8 visits

Follow-up

Participants are monitored for changes in physical activity, mindfulness, self-efficacy, and other health parameters

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• My Viva Plan

Trial Overview The trial tests a web-based platform called My Viva Plan designed for self-care in nutrition and mindfulness to improve physical function in patients with long COVID. It aims to see if this online application can help enhance overall health and quality of life for these individuals.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Use of My Viva Plan

Group II: Control Arm Active Control 1 Intervention

No use of My Viva Plan

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Revive Wellness Inc.

Collaborator

Trials

3

Recruited

160+

Published Research Related to This Trial

The Safe at Home program utilizes Chronic Care Management (CCM) and Remote Patient Monitoring (RPM) to help primary care providers deliver care to Medicare patients during the COVID-19 pandemic, allowing for safe self-isolation while monitoring health.

This program not only supports patients' mental and physical health by tracking COVID-19 symptoms and lifestyle behaviors but also helps practices generate revenue during a time of declining in-person visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Primary Care Answer to a Pandemic: Keeping a Population of Patients Safe at Home through Chronic Care Management and Remote Patient Monitoring. Donohue, D.[2021]

This study aims to evaluate whether adding electronic case management (ECM) to health coaching improves outcomes for individuals with Long COVID over 3 months, compared to health coaching alone, in a randomized controlled trial involving participants receiving usual care.

The trial will assess various outcomes, including disability, cognition, fatigue, and mental health, potentially leading to personalized and scalable care strategies for Long COVID patients, which could inform treatment guidelines at broader levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms. Hatcher, S., Werier, J., Edgar, NE., et al.[2022]

The study analyzed the experiences of 21 older and younger adults with Long COVID who participated in a virtual Integrative Medical Group Visit (IMGV) over 8 weeks, revealing that this approach may be a feasible treatment option for managing symptoms.

Thematic analysis identified key themes in participants' experiences, highlighting both similarities and differences between age groups, which can help clinicians better understand and address the needs of older adults with Long COVID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A descriptive exploration of younger and older adults' experiences of Integrative Medical Group Visits for Long COVID. Mata, R., Bankole, AO., Barnhill, J., et al.[2023]

The REGAIN intervention is a structured online program combining exercise and behavioral support for individuals experiencing long-COVID symptoms, developed through extensive collaboration with patients and stakeholders.

This intervention includes personalized consultations and group sessions over eight weeks, and is currently being tested in a randomized controlled trial to evaluate its clinical and cost-effectiveness for integration into NHS rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online intervention for the Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) trial. Ennis, S., Heine, P., Sandhu, H., et al.[2023]

The UNLOCK study is a pilot trial designed to assess the feasibility of a personalized multimodal treatment for long COVID, involving individualized physical exercise and nutritional therapy over 12 weeks.

This study aims to prepare for a larger randomized controlled trial to evaluate the effectiveness of this personalized approach compared to standard physiotherapy, highlighting the need for a multidisciplinary strategy in managing long COVID symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional performance recovery after individualized nutrition therapy combined with a patient-tailored physical rehabilitation program versus standard physiotherapy in patients with long COVID: a pilot study. Roggeman, S., Jimenez Garcia, BG., Leemans, L., et al.[2023]

The study is testing a customized version of the Optimal Health Program (LC-OHP) for people with long COVID, focusing on its feasibility and acceptability in improving mental and physical health, with 60 participants involved in a randomized controlled trial.

The LC-OHP aims to enhance self-efficacy and overall quality of life for individuals suffering from long COVID, addressing a significant gap in validated treatments for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long COVID Optimal Health Program (LC-OHP) to Enhance Psychological and Physical Health: Protocol for a Feasibility Randomized Controlled Trial. Al-Jabr, H., Windle, K., Thompson, DR., et al.[2022]

Out of 315 participants invited to switch to a virtual weight management program during the COVID-19 pandemic, 72.1% accepted the transition, indicating a strong uptake of remote options.

However, older adults and individuals from Black, Asian, and Minority Ethnic (BAME) backgrounds were less likely to accept the virtual program, highlighting the need for targeted strategies to improve access for these groups, especially given their higher risk for severe COVID-19 outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Socio-demographic predictors of uptake of a virtual group weight management program during the COVID-19 pandemic. Abbott, S., Parretti, HM., Hazlehurst, J., et al.[2021]

A multidisciplinary rehabilitation program for 97 patients with long COVID-19 led to significant improvements in body composition, including a reduction in abdominal fat and an increase in skeletal muscle mass after 6 weeks.

Almost 80% of participants reported improved breathing, and their physical capacity significantly increased, as shown by tests like the 6 Minute Walking Test, indicating the program effectively enhanced overall health and functionality in long COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Multidisciplinary Rehabilitation Program in Patients with Long COVID-19: Post-COVID-19 Rehabilitation (PCR SIRIO 8) Study. Ostrowska, M., Rzepka-Cholasińska, A., Pietrzykowski, Ł., et al.[2023]

The Remote Patient Monitoring (RPM) program for COVID-19 patients showed that 66% of enrolled patients completed the monitoring period without any abnormal alerts, indicating effective home monitoring.

Enrollment in the RPM program was associated with a significant reduction in the odds of emergency department visits or hospital readmissions, with an adjusted odds ratio of 0.54, suggesting that RPM can effectively decrease hospital utilization after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Patient Monitoring Program for Hospital Discharged COVID-19 Patients. Gordon, WJ., Henderson, D., DeSharone, A., et al.[2021]

The ReDIRECT trial is investigating the effectiveness of a digitally delivered weight management program, Counterweight-Plus, in improving Long COVID symptoms among 240 participants with overweight or obesity, over a 12-week intervention period.

Participants are allowed to choose their most significant Long COVID symptom to measure improvement, and the trial includes both process and economic evaluations to assess the intervention's impact and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The remote diet intervention to reduce Long COVID symptoms trial (ReDIRECT): protocol for a randomised controlled trial to determine the effectiveness and cost-effectiveness of a remotely delivered supported weight management programme for people with Long COVID and excess weight, with personalised improvement goals. Haag, L., Richardson, J., Cunningham, Y., et al.[2023]

In a study of 26,743 at-risk adults, those participating in online lifestyle change programs (LCP) achieved a lower effectiveness in weight loss (23% achieving >5% weight loss) compared to in-person programs (35%).

While online programs had a higher enrollment rate (56% vs 51%), they showed lower engagement, with only 46% attending at least 9 sessions compared to 66% for in-person participants, highlighting challenges in maintaining participant involvement in online settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reach, engagement and effectiveness of in-person and online lifestyle change programs to prevent diabetes. Golovaty, I., Wadhwa, S., Fisher, L., et al.[2022]

A 12-week web-based weight loss program significantly reduced COVIDAge and cardiometabolic risk factors in 92 participants with overweight and obesity, showing a greater improvement in the interactive group compared to the control group.

Participants in the interactive program experienced a 4.2% reduction in COVIDAge and greater decreases in body measurements and systolic blood pressure, indicating that such online health interventions can effectively support weight loss and improve health outcomes during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 12-Week Web-Based Weight Loss Program for Adults With Overweight and Obesity on COVIDAge and Lifestyle-Related Cardiometabolic Risk Factors: A Randomized Controlled Trial. Brame, J., Centner, C., Berg, N., et al.[2022]

The virtual adaptation of the Healthy Action to Benefit Independence and Thinking (HABIT) program for patients with mild cognitive impairment maintained high satisfaction levels among participants, with scores ranging from 5.8 to 6.6 on a scale of 1 to 7.

Clinical outcomes, including reductions in patient and partner anxiety and partner depression, were consistent with those from in-person sessions, indicating that the virtual format is an effective alternative for delivering cognitive rehabilitation during public health restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovation Inspired by COVID: A Virtual Treatment Program for Patients With Mild Cognitive Impairment at Mayo Clinic. Locke, DEC., Khayoun, R., Shandera-Ochsner, AL., et al.[2021]

Citations

1. recovercovid.org recovercovid.org/publications/post-acute-sequelae-sars-cov-2-infection-long-covid-older-adults

Post-acute sequelae of SARS-CoV-2 infection (Long ... Long COVID, also known as PASC (post-acute sequelae of SARS-CoV-2), is a complex infection-associated chronic condition affecting tens of millions of people ...

2. cdc.gov cdc.gov/mmwr/volumes/70/wr/mm7037a2.htm

Post-Acute Sequelae of SARS-CoV-2 Infection Among ... This report describes identification of post-acute sequelae in recovered COVID-19 patients in Long Beach, California.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11493926/

Post-acute sequelae of SARS-CoV-2 infection (Long COVID ... Long COVID, also known as PASC (post-acute sequelae of SARS-CoV-2), is a complex infection-associated chronic condition affecting tens of millions of people ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40124412/

Long-term outcomes of post-acute sequelae of SARS-CoV ... Our study aims to address this knowledge gap by analyzing the long-term health implications of PASC, utilizing a comprehensive integration of ...

5. ccjm.org ccjm.org/content/88/5/267

Post-acute sequelae of SARS-CoV-2 infection: Caring for ... In patients with PASC, symptoms may persist for more than 60 days and as long as 6 months. Focus treatment on managing comorbidities, pulmonary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9247346/

Post-acute Sequelae of SARS-CoV-2 Infection There is an increased long-term risk of cardiovascular complications such as heart failure among patients with SARS-CoV-2 infection, even among ...

7. now.aapmr.org now.aapmr.org/pasc-long-covid/

Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)/Long ... Any patient with new or persistent symptoms lasting more than 12 weeks after acute infection should have an assessment for PASC. It is crucial ...