IMGV for Long COVID

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Last modified date
  • June 22, 2022
Creator
  • Barnhill, Jessica
    • ORCID: https://orcid.org/
    • Affiliation: School of Medicine, Department of Physical Medicine and Rehabilitation
Abstract
  • Pilot data supports virtual Integrative Medical Group Visits for people with Long COVID Abstract Background Long COVID is a common, debilitating post-infectious illness following mild to severe COVID infections. Effective management of Long COVID is currently unknown. Shared Medical Appointments or Integrative Medical Group Visits (IMGV) are effective interventions for chronic conditions. Virtual IMGVs may improve management of Long COVID. Objective This single arm non-randomized study assessed the feasibility of patient-reported outcome measures to study a virtual IMGV for Long COVID. Data from IMGV for Long COVID participants will guide program development and contribute to the evidence base for management of Long COVID. Methods Surveys administered before and after the group intervention measured anxiety, perceived stress, fatigue, sleep quality, and patient-specific symptomatology among patients from a tertiary care COVID recovery clinic. Paired t-tests quantified change in self-reported measures. Results Fourteen patients with Long COVID completed the intervention and pre and post measures (78.6% female, 71.4% non-Hispanic White, mean age 48.9 years). Chief symptomatology was fatigue, shortness of breath and “brain fog.” Symptoms decreased in interference when compared to pre-intervention levels (mean difference -1.3 [95% CI-2.2, -0.5]). There was no change in self-reported unrefreshing sleep or overall wellness. Perceived stress scores decreased after the intervention compared to baseline (mean difference -3.4 [95% CI -5.8, -1.1]). Conclusion Patient-reported outcome measures of perceived stress and symptom interference improved post-intervention. Few effective interventions are currently available for this large and growing population facing debilitating symptoms. Larger studies are needed to explore the potential of Integrative Medical Group Visits to improve quality of life among people with Long COVID.
Methodology
  • Study design This study was a single-arm nonrandomized study designed to assess feasibility of using patient-reported outcome measures to study virtual Integrative Medical Group Visits for the treatment of Long COVID. Setting Participants were recruited from a university based post-COVID clinic. The group was offered to patients regardless of their interest in research participation. This study was approved by the University of North Carolina IRB under number 21-1326. Measures Four patient-reported outcome measures (PROMs) were utilized in this study. The Perceived Stress Scale (PSS-10), the General Anxiety Disorder two question tool (GAD-2), three questions from the Fibromyalgia Symptom Severity Scale (SSS), and the Measure Yourself Medical Outcome Profile (MYMOP®). The Measure Yourself Medical Outcome Profile (MYMOP®) is designed to prioritize and measure changes important to a person/patient. The MYMOP instructs patients to “Choose one or two symptoms that bother you the most.” Patients then consider these symptoms individually, ranking how bad those symptoms have been over the past week with a zero indicating, “as good as it could be” and a six indicating “as bad as it could be.” Using the same scale, the person is directed to “Choose one activity (physical, social, or mental) that is important to you, and that your problem makes difficult or prevents you from doing. Score how bad it has been in the last week.” These questions are repeated later, supplying the patient with the symptoms and activity chosen at the first time point.11 MYMOP® was validated against the Short Form Health Survey (SF-36) in 1996.12 A more recent critical appraisal, published in 2019, recommended additional validation following the COSMIN criteria.13 The MYMOP® is scored by comparing change in mean score for each question. The MYMOP® profile is the average of the changes in individual component mean scores. The Perceived Stress Scale (PSS-10) is a 10-item self-report psychological instrument designed to measure the perception of stress. The questions ask about thoughts and feelings related to emotional reactions to stress, irritations, and control over the past month. Scores range from 0 to 40 with higher scores indicating higher perceived stress. The PSS-10 has demonstrated internal consistency reliability with a Cronbach’s alpha score of >70.14 The Generalized Anxiety Disorder Scale two-item questionnaire (GAD-2) is a validated shortened form of the GAD-7, designed to screen for the presence of generalized anxiety disorder using the first two questions from the GAD-7, temporally anchored to the previous two weeks, participants are asked to report how often they have been bothered by feeling nervous, anxious or on edge and how often they were bothered by not being able to stop or control worrying. Scores range from 0 to 3. The two items are summed. A score of 3 points is the preferred cut-off for identifying possible cases and in which further diagnostic evaluation for generalized anxiety disorder is warranted. Using a cut-off of 3 the GAD-2 has a sensitivity of 86% and specificity of 83% for diagnosis generalized anxiety disorder.15 We utilized three individual items from the Fibromyalgia Symptoms Severity Scale (SSS) measuring the following: fatigue, waking unrefreshed, and trouble thinking. For each symptom, participants were asked to rate the level of severity of each symptom in the past week from 0 representing no problem to 3 representing severe, pervasive, continuous, life-disturbing problems. A SSS score equal or greater than five is combined with the widespread pain index for diagnostic criteria of fibromyalgia.16 Research Protocol After being referred to IMGV from the COVID Recovery Clinic, the study was introduced to patients by a physician (JB) and interest was garnered. Interested patients were contacted over the phone for verbal consent in a pre-intervention interview. Interviews were conducted using Zoom teleconferencing software in the weeks prior to patients beginning IMGV. Deidentified data was stored on Microsoft Teams. Information connecting the study ID to the patient was stored on a password-protected document in Microsoft Teams. Post-intervention measures were collected in a similar fashion. Participants were contacted over the phone to set up post-interviews. Post-intervention measures were collected from all consented participants who were reachable by phone or email. This study received exempt status from the IRB. Intervention The Nourish to Flourish (N2F) program for people with Long COVID was adapted from the previously tested IMGV model for people with chronic pain (Gardiner, 2019). IMGV had previously been implemented and adapted for telehealth delivery at the University of North Carolina, at the start of the COVID-19 pandemic.17 After finding that IMGV for patients with chronic pain delivered via telehealth was feasible and acceptable to both patients and providers18, faculty at the newly opened COVID Recovery Clinic suggested adapting the IMGV model for patients with Long-COVID. The IMGV curriculum content includes health education on stress, inflammation, sleep, pain, depression, and nutrition. Experiential activities include mindfulness mediations (awareness of breath meditation, body scan, mindful eating, sitting meditation, chair yoga, and loving kindness meditation), self-acupressure, gratitude journaling, self-massage, and goal setting, as well as anti-inflammatory diet recipes.9 The original IMGV curriculum was adapted for N2F to remove certain topics of particular relevance to people with chronic pain (pain education) and replace them with topics relevant to people with Long COVID such as neuroplasticity, energy pacing (Table 1). The original IMGV model provided patients with a printed manual as well as access to an electronic resource aimed at supplementing the curriculum content. For telehealth delivery of the IMGV for patients with chronic pain, patients received a digital copy of the curriculum manual and access to a website with supplemental materials (such as meditation videos and audio recordings, health education videos, and worksheets). For N2F, the manual and website were modified to reflect the updated curriculum content for people with Long COVID. IMGV was originally designed to be delivered in-person in primary care clinics, usually in a conference room, break room, or other space large enough to accommodate the group. Groups ranged in size from about 8 to 12 patients. 19 The intervention is delivered by a billing provider, either a physician or advanced practice provider, as well as a mindfulness instructor or yoga teacher. The physician and yoga instructor attended a training on facilitation of integrative medical group visits prior to implementation of the program. The training was provided by the Integrated Center for Group Medical Visits in Lawrence, Massachusetts. To deliver IMGV via telehealth, the intervention was adapted for delivery on the zoom teleconferencing platform. When needed, patients received an orientation to zoom, as well as printed instructions on how to use the platform. For N2F, the first cohort of the intervention was delivered by the same physician and yoga instructor team that had previously been leading the IMGV for patients with chronic pain. When the yoga instructor went on parental leave after the first cohort completed the N2F program, this provided an opportunity to bring on a new co-facilitator. The second cohort of N2F was co-facilitated by one of the patients with Long COVID who had participated in the first cohort (who had previous experience in mindfulness, yoga, and group facilitation). The original IMGV was delivered in person for 2.5 hours weekly over 9 weeks, followed by a 10th session at 21 weeks. For telehealth delivery, and when implementing IMGV in a new context, the 10th session was cut for feasibility purposes. When designing N2F, the intervention was shortened to 8 weeks, again for the purpose of easing scheduling challenges for an ongoing program. The providers found that starting new cohorts on the first week of a month was easier for scheduling purposes. Statistical Analysis The outcomes of interest were the four PROMS described above: PSS-10, GAD-2, SSS, and MYMOP®. After confirming normality among these continuous variables, we compared baseline and post-intervention scores using paired t-tests to control for within-individual variability. We performed a complete case analysis using the fourteen participants who completed the intervention and both assessments. The a priori alpha was set to 0.05 for the two-tailed p-values. We were interested in both clinical significance as well as statistical significance, therefore, we calculated the magnitude of differences in the pre and post scores as well as the 95% confidence intervals around the mean difference. Given the small sample size and the exploratory nature of the analysis, no subgroup analyses or interactions were tested. All analyses were performed in SAS 9.4.20
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Kind of data
  • Numeric
Resource type
  • Dataset
License
  • CC0 1.0 Universal
Language
  • English

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file details Post-Interview_Data__QUANT_.xlsx 2022-06-22 Public Download
file details Pre-Interview_Data__QUANT_.xlsx 2022-06-22 Public Download
file details NourishtoFluorish_DataDictionary__1_.xlsx 2022-06-22 Public Download