SARS-CoV-2 Acute Respiratory DiseaseLC&FIRPNCT05167227
Does a Technology Enabled Multi-disciplinary Team-based Care Model for the Management of Long COVID and Other Fatiguing Illnesses Improve Clinical Care of Patients and Represent a Sustainable Approach Within a Federally Qualified Health Center?
A study testing Extension for Community Healthcare Outcomes in people with SARS-CoV-2 Acute Respiratory Disease and Myalgic Encephalomyelitis, run by Family Health Centers of San Diego at 1 site in United States.
Trial summary
The primary objective of the present research is to determine the effectiveness of Family Health Center of San Diego's Long COVID and Fatiguing Illness Recovery Program (LC\&FIRP) on clinician- and patient-level outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Acute Respiratory Disease, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome
- What is being tested?
- Extension for Community Healthcare Outcomes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria for clinicians includes 1) being employed by FHCSD for clinical care delivery, 2) being a licensed primary care physician, physician assistant, or nurse practitioner, 3) caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with PASC, ME/CFS, and/or OPIFI, and 4) being willing and able to actively participate in LC\&FIRP.
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Health Centers of San Diego
San Diego, California, 92102
About this study
Official title: The Long COVID and Fatiguing Illness Recovery Program - A Pragmatic, Quality Improvement, Professional Cluster, Randomized Controlled Trial.
The primary objective of the present research is to determine the effectiveness of Family Health Center of San Diego's Long COVID and Fatiguing Illness Recovery Program (LC\&FIRP) on clinician- and patient-level outcomes. LC\&FIRP is comprised of a teleECHO program focused on multi-specialty case-consultation and peer-to-peer sharing of emerging best practices to support management of complex cases associated with Long COVID, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and other post-infectious fatiguing illnesses (PIFI). Our secondary objective is to determine the feasibility, acceptability, and sustainability of LC\&FIRP. Our findings should provide a fuller understanding of the potential impact of innovative technology enabled multi-disciplinary team-based care models in low-resource, community-based primary care settings.
Read the detailed description
The primary objective of the present research is to determine the effectiveness of FHCSD's Long COVID and Fatiguing Illness Recovery Program (LC\&FIRP) on clinician- and patient-level outcomes. LC\&FIRP is comprised of a teleECHO program focused on multi-specialty case-consultation and peer-to-peer sharing of emerging best practices to support management of complex cases associated with Long COVID, ME/CFS, and other PIFI. Our secondary objective is to determine the feasibility, acceptability, and sustainability of LC\&FIRP. Our findings should provide a fuller understanding of the potential impact of innovative technology enabled multi-disciplinary team-based care models in low-resource, community-based primary care settings. This study will provide much needed high-quality evidence on the effectiveness of a technology enabled multi-disciplinary team-based care model for the management of Long COVID, ME/CFS, and other PIFI within a community clinic setting, while simultaneously providing evidence regarding the feasibility, acceptability, and sustainability of the approach. Given that LC\&FIRP includes a teleECHO program that is case-based, interactive, and occurs in real-time, it has a set of distinct advantages to the traditional practice of sequential in-person specialty referrals to address complex patient cases. The investigators hypothesize that clinician exposure to weekly teleECHO sessions with monthly interactive webinars and quarterly short courses will significantly improve clinician- and patient-level outcomes compared to clinician exposure to monthly interactive webinars and quarterly short courses alone.
The investigators will evaluate LC\&FIRP using an effectiveness-implementation hybrid type 2 design. Specifically, the investigators will conduct a two-arm, single-blind, pragmatic, quality improvement, professional cluster, randomized controlled trial. The target for weekly teleECHO sessions, monthly interactive webinars, and quarterly short courses are licensed health care professionals. Therefore, the present research will include professional clusters that will consist of primary care physicians, physician assistants, and nurse practitioners at FHCSD caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with Long COVID, ME/CFS, and/or other PIFI.
20 consenting clinicians across primary care clinics at FHCSD will be randomized at a ratio of 1:1 to either participate in 1) weekly teleECHO sessions with monthly interactive webinars and quarterly short courses or 2) monthly interactive webinars and quarterly short courses alone (a control group). All clinicians will have the option to receive continuing medical education credit for the educational sessions they engage in. Throughout participation, the investigators expect that the clinicians will provide care for approximately 856 FHCSD patients diagnosed with Long COVID, ME/CFS, or other PIFI (approximately 42 patients per clinician). The clinicians will be consented and will receive exposure to intervention components (i.e., a professional cluster). Therefore, patient outcomes derived from routine clinical care will be evaluated according to the study arm of their respective clinicians. Outcomes will be measured at 3-, 6-, 9-,12-, 18-, 24-, and 30-months post-baseline for clinicians and for patients at 3-, 6-, 9-, and 12-months post assignment to a participating clinician.
Inclusion criteria for clinicians includes 1) being employed by FHCSD for clinical care delivery, 2) being a licensed primary care physician, physician assistant, or nurse practitioner, 3) caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with Long COVID, ME/CFS, and/or other PIFI, and 4) being willing and able to actively participate in LC\&FIRP. There are no exclusion criteria. FHCSD medical leadership has verbally extended an invitation to the approximately 200 eligible clinicians at FHCSD to participate in LC\&FIRP (a follow-up email will also be sent). Those who are interested will provide written informed consent, complete a baseline survey, and will be randomized to one of the two study arms. An electronic randomization list will be generated using the latest version of the statistical software platform R (version 3.3.2, http://www.r-project.org). The list will be securely integrated into the cloud-based Research Electronic Data Capture (REDCap) tool. Allocation will be concealed from all investigators and staff until the study group is assigned. Only the study manager and research assistants involved in the delivery of the intervention components will subsequently be made aware of allocation. It is not possible to mask participating clinicians, however, patients of participating clinicians will not have knowledge of their clinicians potential participation in weekly teleECHO sessions, monthly interactive webinars, and quarterly short courses. All staff that are involved in the collection of data and investigators that conduct analyses will remain blinded to allocation throughout the study.
Clinician participation in this study is voluntary. Participating clinicians may decide not to participate or may leave the study at any time. This decision will not result in any penalty or loss of benefits to which they are entitled. Information that has already been collected may still be used, but no new information will be collected. The withdrawal reason and the withdrawal date will be documented.
- Conditions
- SARS-CoV-2 Acute Respiratory Disease, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Post-acute Sequelae of SARS-COV-2 Infection, Post COVID-19 Condition
- Being tested
- Extension for Community Healthcare Outcomes
- Keywords
- Long COVID, ME, CFS, PASC, PCC
- Medical subject headings
- Fatigue Syndrome, Chronic, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extension for Community Healthcare OutcomesOther
Also called ECHO
ECHO is a technology enabled multi-disciplinary team-based care model centered on case-consultation and peer-to-peer sharing of emerging best practices (i.e., teleECHO) to support management of complex cases associated with Long COVID, ME/CFS, and other PIFI.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The Control arm participates in monthly interactive webinars and quarterly short courses. Monthly interactive webinars will offer brief didactic presentations by SMEs, examples of models of care, and a facilitated Q\&A. These webinars will be convened to rapidly disseminate findings and emerging best practices to a large-scale, national audience. Quarterly short courses will be developed to summarize key findings from past weekly teleECHO sessions. These quarterly short courses will be formatted as a learning module with the use of presentation slides and videos online that are accessible asynchronously. |
| Intervention | Experimental | The Intervention arm participates in weekly teleECHO sessions with monthly interactive webinars and quarterly short courses. Receives: Other: Extension for Community Healthcare Outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Patient baseline and quarterly surveys
Measured: During 12 months of follow-up
Secondary outcomes (38)
Patient symptom checklist with associated severity for those present
Patient baseline and quarterly surveys, None, Mild, Moderate, Severe
Measured: During 12 months of follow-up
If symptom is present, has patient experienced this in the past month
Patient baseline and quarterly surveys, Yes/No
Measured: During 12 months of follow-up
If symptom is present, how long has patient experienced this symptom
Patient baseline and quarterly surveys, Under 3 Months, 3 Months or longer
Measured: During 12 months of follow-up
If symptom is present, did patient have this symptom before the patient tested positive for COVID-19?
Patient baseline and quarterly surveys, Yes/No
Measured: During 12 months of follow-up
If symptom is present, during the past month how often have the patient had this symptom?
Patient baseline and quarterly surveys with use of Likert scale
Measured: During 12 months of follow-up
If symptom is present during the past month, how bad was this symptom?
Patient baseline and quarterly surveys with use of Likert scale
Measured: During 12 months of follow-up
For symptoms present, do any of them get worse for at least 24 hours after engaging in activities (physical or mental) that patient was used to doing with no problems?
Patient baseline and quarterly surveys with Yes/No/Not Applicable/Don't Know
Measured: During 12 months of follow-up
If fatigue, tiredness, or exhaustion is present, doesn't patient describe it as feeling it come on all of a sudden, or slowly over time
Patient baseline and quarterly surveys with All of sudden, Slowly over time, Not applicable, Don't know
Measured: During 12 months of follow-up
If fatigue present, what month and year did the fatiguing illness begin?
Patient baseline and quarterly surveys, estimated month and year
Measured: During 12 months of follow-up
When fatigued, does rest make patient's fatigue better?
Patient baseline and quarterly surveys, Yes a lot, Yes a little, No not very much, Not applicable, Don't know
Measured: During 12 months of follow-up
When fatigued, has this fatigue substantially limited the patient's ability to occupational, educational, social, or personal activities?
Patient baseline and quarterly surveys, Yes, No, Not applicable, Don't know
Measured: During 12 months of follow-up
Patient's medical history check-list
Patient baseline survey, Yes, No, Unsure
Measured: Through study referral period, an average of 12 weeks
Patient's dietary restrictions
Patient baseline survey, No, Vegan, Vegetarian, Ketogenic, Gluten-free, Dairy-free, Intermittent fasting, Other
Measured: Through study referral period, an average of 12 weeks
Patient's food allergies or other food intolerances
Patient baseline survey, Yes/No
Measured: Through study referral period, an average of 12 weeks
Has patient's employment been impacted due to contracting COVID-19?
Patient baseline survey, Yes, No
Measured: Through study referral period, an average of 12 weeks
Patient's frequency to complete 150-minutes per week of moderate-intensity physical activity (like a brisk walk, slow biking, gardening, or ballroom dancing) prior to contracting COVID-19
Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know
Measured: Through study referral period, an average of 12 weeks
Patient's frequency to complete 150-minutes per week of vigorous-intensity physical activity (like running, swimming laps, competitive sports, or fast bicycling) prior to contracting COVID-19
Patient baseline survey, Every week, Most weeks, Some weeks, Very few weeks, Never, I do not know
Measured: Through study referral period, an average of 12 weeks
Did patient receive a COVID-19 PCR (nasal swab) test
Patient baseline survey, Yes/No
Measured: Through study referral period, an average of 12 weeks
Did patient receive a COVID-19 antibody test
Patient baseline survey, Yes/No
Measured: Through study referral period, an average of 12 weeks
Patient symptom onset
Patient baseline survey, Date
Measured: Through study referral period, an average of 12 weeks
Patient reported medications used for COVID-19 symptoms
Patient baseline survey, free text
Measured: Through study referral period, an average of 12 weeks
Patient reported prescribed supplementary oxygen support
Patient baseline survey, Yes/No
Measured: Through study referral period, an average of 12 weeks
Patient reported admittance to hospital due to COVID-19
Patient baseline and quarterly surveys, Yes/No
Measured: During 12 months of follow-up
Do any of the following activities exacerbate patients symptoms: Physical exertion, Diet Changes, Big Meal, Dehydration, Weather changes (hot and humid), Tight clothing, Stress or anxiety, Pre Menstrual period, Menstrual period, Alcohol consumption
Patient baseline and quarterly surveys, Yes/No
Measured: During 12 months of follow-up
Does patient feel fully recovered from COVID-19
Patient quarterly surveys, Yes/No
Measured: During 9 months of follow-up
Currently minutes per week of moderate-intensity physical activity patient does (like a brisk walk, slow biking, gardening, or ballroom dancing)
Patient quarterly surveys, free text
Measured: During 9 months of follow-up
Currently minutes per week of vigorous-intensity physical activity patient does (like running, swimming laps, competitive sports, or fast bicycling)
Patient quarterly surveys, free text
Measured: During 9 months of follow-up
Patient Health Questionnaire (PHQ)-2
Patient baseline and quarterly surveys
Measured: During 12 months of follow-up
Patient Health Questionnaire (PHQ)-9 (if applicable)
Patient baseline and quarterly surveys
Measured: During 12 months of follow-up
PROMIS Dyspnea Functional Limitations and Severity Short Forms
Patient baseline and quarterly surveys
Measured: During 12 months of follow-up
PROMIS Applied Cognition Abilities and General Concerns Short Forms
Patient baseline and quarterly surveys
Measured: During 12 months of follow-up
Generalized Anxiety Disorder (GAD)-7
Patient baseline and quarterly surveys
Measured: During 12 months of follow-up
2-minute step test
Physical Therapy assessment with patient
Measured: During 12 months of follow-up
30 sec sit to stand test
Physical Therapy assessment with patient
Measured: During 12 months of follow-up
Grip strength
Physical Therapy assessment with patient
Measured: During 12 months of follow-up
Functional Gait Assessment
Physical Therapy assessment with patient
Measured: During 12 months of follow-up
Balance tasks
Physical Therapy assessment with patient
Measured: During 12 months of follow-up
Post-exertional malaise follow-up
Follow-up Physical Therapy appointment with patient, Not at all, A little bit, Somewhat, Quite a bit, Very much
Measured: Per Physical Therapy encounter after PT assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start30 Nov 2021
- Primary completion20 Nov 2024
- Study completion28 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 Acute Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 20 consenting clinicians across primary care clinics at FHCSD will be randomized at a ratio of 1:1 to either participate in 1) weekly teleECHO sessions with monthly interactive webinars and quarterly short courses or 2) monthly interactive webinars and quarterly short courses alone (a control group). Throughout participation, the investigators expect that the clinicians will provide care for approximately 856 FHCSD patients diagnosed with PASC, ME/CFS, or OPIFI (approximately 42 patients per clinician). The clinicians will be consented and will receive exposure to intervention components (i.e., a professional cluster). Therefore, patient outcomes derived from routine clinical care will be evaluated according to the study arm of their respective clinicians.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Family Health Centers of San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Ramers, MD, Principal investigator, Family Health Centers of San DiegoJob Godino, PhD, Principal investigator, Family Health Centers of San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167227
- Sponsor's protocol ID
- HS-2021-0241
- Acronym
- LC&FIRP
- Status last verified
- Aug 2025
- First submitted
- 17 Dec 2021
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Godino JG, Samaniego JC, Sharp SP, Taren D, Zuber A, Armistad AJ, Dezan AM, Leyba AJ, Friedly JL, Bunnell AE, Matthews E, Miller MJ, Unger ER, Bertolli J, Hinckley A, Lin JS, Scott JD, Struminger BB, Ramers C. A technology-enabled multi-disciplinary team-based care model for the management of Long COVID and other fatiguing illnesses within a federally qualified health center: protocol for a two-arm, single-blind, pragmatic, quality improvement professional cluster randomized controlled trial. Trials. 2023 Aug 12;24(1):524. doi: 10.1186/s13063-023-07550-3.
PubMed 37573421
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long COVID and Fatiguing Illness Recovery Program - A Pragmatic, Quality Improvement, Professional Cluster, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05167227
- Acronym / sponsor ID
- LC&FIRP / HS-2021-0241
- Conditions
- SARS-CoV-2 Acute Respiratory Disease, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Post-acute Sequelae of SARS-COV-2 Infection, Post COVID-19 Condition
- Keywords
- Long COVID, ME, CFS, PASC, PCC
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Family Health Centers of San DiegoUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 28 Nov 2025 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the present research is to determine the effectiveness of Family Health Center of San Diego's Long COVID and Fatiguing Illness Recovery Program (LC\&FIRP) on clinician- and patient-level outcomes. LC\&FIRP is comprised of a teleECHO program focused on multi-specialty case-consultation and peer-to-peer sharing of emerging best practices to support management of complex cases associated with Long COVID, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and other post-infectious fatiguing illnesses (PIFI). Our secondary objective is to determine the feasibility, acceptability, and sustainability of LC\&FIRP. Our findings should provide a fuller understanding of the potential impact of innovative technology enabled multi-disciplinary team-based care models in low-resource, community-based primary care settings.
Detailed description
The primary objective of the present research is to determine the effectiveness of FHCSD's Long COVID and Fatiguing Illness Recovery Program (LC\&FIRP) on clinician- and patient-level outcomes. LC\&FIRP is comprised of a teleECHO program focused on multi-specialty case-consultation and peer-to-peer sharing of emerging best practices to support management of complex cases associated with Long COVID, ME/CFS, and other PIFI. Our secondary objective is to determine the feasibility, acceptability, and sustainability of LC\&FIRP. Our findings should provide a fuller understanding of the potential impact of innovative technology enabled multi-disciplinary team-based care models in low-resource, community-based primary care settings. This study will provide much needed high-quality evidence on the effectiveness of a technology enabled multi-disciplinary team-based care model for the management of Long COVID, ME/CFS, and other PIFI within a community clinic setting, while simultaneously providing evidence regarding the feasibility, acceptability, and sustainability of the approach. Given that LC\&FIRP includes a teleECHO program that is case-based, interactive, and occurs in real-time, it has a set of distinct advantages to the traditional practice of sequential in-person specialty referrals to address complex patient cases. The investigators hypothesize that clinician exposure to weekly teleECHO sessions with monthly interactive webinars and quarterly short courses will significantly improve clinician- and patient-level outcomes compared to clinician exposure to monthly interactive webinars and quarterly short courses alone.
The investigators will evaluate LC\&FIRP using an effectiveness-implementation hybrid type 2 design. Specifically, the investigators will conduct a two-arm, single-blind, pragmatic, quality improvement, professional cluster, randomized controlled trial. The target for weekly teleECHO sessions, monthly interactive webinars, and quarterly short courses are licensed health care professionals. Therefore, the present research will include professional clusters that will consist of primary care physicians, physician assistants, and nurse practitioners at FHCSD caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with Long COVID, ME/CFS, and/or other PIFI.
20 consenting clinicians across primary care clinics at FHCSD will be randomized at a ratio of 1:1 to either participate in 1) weekly teleECHO sessions with monthly interactive webinars and quarterly short courses or 2) monthly interactive webinars and quarterly short courses alone (a control group). All clinicians will have the option to receive continuing medical education credit for the educational sessions they engage in. Throughout participation, the investigators expect that the clinicians will provide care for approximately 856 FHCSD patients diagnosed with Long COVID, ME/CFS, or other PIFI (approximately 42 patients per clinician). The clinicians will be consented and will receive exposure to intervention components (i.e., a professional cluster). Therefore, patient outcomes derived from routine clinical care will be evaluated according to the study arm of their respective clinicians. Outcomes will be measured at 3-, 6-, 9-,12-, 18-, 24-, and 30-months post-baseline for clinicians and for patients at 3-, 6-, 9-, and 12-months post assignment to a participating clinician.
Inclusion criteria for clinicians includes 1) being employed by FHCSD for clinical care delivery, 2) being a licensed primary care physician, physician assistant, or nurse practitioner, 3) caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with Long COVID, ME/CFS, and/or other PIFI, and 4) being willing and able to actively participate in LC\&FIRP. There are no exclusion criteria. FHCSD medical leadership has verbally extended an invitation to the approximately 200 eligible clinicians at FHCSD to participate in LC\&FIRP (a follow-up email will also be sent). Those who are interested will provide written informed consent, complete a baseline survey, and will be randomized to one of the two study arms. An electronic randomization list will be generated using the latest version of the statistical software platform R (version 3.3.2, http://www.r-project.org). The list will be securely integrated into the cloud-based Research Electronic Data Capture (REDCap) tool. Allocation will be concealed from all investigators and staff until the study group is assigned. Only the study manager and research assistants involved in the delivery of the intervention components will subsequently be made aware of allocation. It is not possible to mask participating clinicians, however, patients of participating clinicians will not have knowledge of their clinicians potential participation in weekly teleECHO sessions, monthly interactive webinars, and quarterly short courses. All staff that are involved in the collection of data and investigators that conduct analyses will remain blinded to allocation throughout the study.
Clinician participation in this study is voluntary. Participating clinicians may decide not to participate or may leave the study at any time. This decision will not result in any penalty or loss of benefits to which they are entitled. Information that has already been collected may still be used, but no new information will be collected. The withdrawal reason and the withdrawal date will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 20 consenting clinicians across primary care clinics at FHCSD will be randomized at a ratio of 1:1 to either participate in 1) weekly teleECHO sessions with monthly interactive webinars and quarterly short courses or 2) monthly interactive webinars and quarterly short courses alone (a control group). Throughout participation, the investigators expect that the clinicians will provide care for approximately 856 FHCSD patients diagnosed with PASC, ME/CFS, or OPIFI (approximately 42 patients per clinician). The clinicians will be consented and will receive exposure to intervention components (i.e., a professional cluster). Therefore, patient outcomes derived from routine clinical care will be evaluated according to the study arm of their respective clinicians.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The Control arm participates in monthly interactive webinars and quarterly short courses. Monthly interactive webinars will offer brief didactic presentations by SMEs, examples of models of care, and a facilitated Q\&A. These webinars will be convened to rapidly disseminate findings and emerging best practices to a large-scale, national audience. Quarterly short courses will be developed to summarize key findings from past weekly teleECHO sessions. These quarterly short courses will be formatted as a learning module with the use of presentation slides and videos online that are accessible asynchronously. |
| Intervention | Experimental | Other: Extension for Community Healthcare OutcomesThe Intervention arm participates in weekly teleECHO sessions with monthly interactive webinars and quarterly short courses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria for clinicians includes 1) being employed by FHCSD for clinical care delivery, 2) being a licensed primary care physician, physician assistant, or nurse practitioner, 3) caring for patients who have had persistent symptoms and a decline in health-related quality of life associated with PASC, ME/CFS, and/or OPIFI, and 4) being willing and able to actively participate in LC\&FIRP.
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extension for Community Healthcare OutcomesAlso: ECHOECHO is a technology enabled multi-disciplinary team-based care model centered on case-consultation and peer-to-peer sharing of emerging best practices (i.e., teleECHO) to support management of complex cases associated with Long COVID, ME/CFS, and other PIFI. | Other | Intervention |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Time frame: During 12 months of follow-up
Patient baseline and quarterly surveys
38 secondary outcomes
Patient symptom checklist with associated severity for those present
Time frame: During 12 months of follow-up
If symptom is present, has patient experienced this in the past month
Time frame: During 12 months of follow-up
If symptom is present, how long has patient experienced this symptom
Time frame: During 12 months of follow-up
If symptom is present, did patient have this symptom before the patient tested positive for COVID-19?
Time frame: During 12 months of follow-up
If symptom is present, during the past month how often have the patient had this symptom?
Time frame: During 12 months of follow-up
If symptom is present during the past month, how bad was this symptom?
Time frame: During 12 months of follow-up
For symptoms present, do any of them get worse for at least 24 hours after engaging in activities (physical or mental) that patient was used to doing with no problems?
Time frame: During 12 months of follow-up
If fatigue, tiredness, or exhaustion is present, doesn't patient describe it as feeling it come on all of a sudden, or slowly over time
Time frame: During 12 months of follow-up
If fatigue present, what month and year did the fatiguing illness begin?
Time frame: During 12 months of follow-up
When fatigued, does rest make patient's fatigue better?
Time frame: During 12 months of follow-up
When fatigued, has this fatigue substantially limited the patient's ability to occupational, educational, social, or personal activities?
Time frame: During 12 months of follow-up
Patient's medical history check-list
Time frame: Through study referral period, an average of 12 weeks
Patient's dietary restrictions
Time frame: Through study referral period, an average of 12 weeks
Patient's food allergies or other food intolerances
Time frame: Through study referral period, an average of 12 weeks
Has patient's employment been impacted due to contracting COVID-19?
Time frame: Through study referral period, an average of 12 weeks
Patient's frequency to complete 150-minutes per week of moderate-intensity physical activity (like a brisk walk, slow biking, gardening, or ballroom dancing) prior to contracting COVID-19
Time frame: Through study referral period, an average of 12 weeks
Patient's frequency to complete 150-minutes per week of vigorous-intensity physical activity (like running, swimming laps, competitive sports, or fast bicycling) prior to contracting COVID-19
Time frame: Through study referral period, an average of 12 weeks
Did patient receive a COVID-19 PCR (nasal swab) test
Time frame: Through study referral period, an average of 12 weeks
Did patient receive a COVID-19 antibody test
Time frame: Through study referral period, an average of 12 weeks
Patient symptom onset
Time frame: Through study referral period, an average of 12 weeks
Patient reported medications used for COVID-19 symptoms
Time frame: Through study referral period, an average of 12 weeks
Patient reported prescribed supplementary oxygen support
Time frame: Through study referral period, an average of 12 weeks
Patient reported admittance to hospital due to COVID-19
Time frame: During 12 months of follow-up
Do any of the following activities exacerbate patients symptoms: Physical exertion, Diet Changes, Big Meal, Dehydration, Weather changes (hot and humid), Tight clothing, Stress or anxiety, Pre Menstrual period, Menstrual period, Alcohol consumption
Time frame: During 12 months of follow-up
Does patient feel fully recovered from COVID-19
Time frame: During 9 months of follow-up
Currently minutes per week of moderate-intensity physical activity patient does (like a brisk walk, slow biking, gardening, or ballroom dancing)
Time frame: During 9 months of follow-up
Currently minutes per week of vigorous-intensity physical activity patient does (like running, swimming laps, competitive sports, or fast bicycling)
Time frame: During 9 months of follow-up
Patient Health Questionnaire (PHQ)-2
Time frame: During 12 months of follow-up
Patient Health Questionnaire (PHQ)-9 (if applicable)
Time frame: During 12 months of follow-up
PROMIS Dyspnea Functional Limitations and Severity Short Forms
Time frame: During 12 months of follow-up
PROMIS Applied Cognition Abilities and General Concerns Short Forms
Time frame: During 12 months of follow-up
Generalized Anxiety Disorder (GAD)-7
Time frame: During 12 months of follow-up
2-minute step test
Time frame: During 12 months of follow-up
30 sec sit to stand test
Time frame: During 12 months of follow-up
Grip strength
Time frame: During 12 months of follow-up
Functional Gait Assessment
Time frame: During 12 months of follow-up
Balance tasks
Time frame: During 12 months of follow-up
Post-exertional malaise follow-up
Time frame: Per Physical Therapy encounter after PT assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Derived from this study: PubMed 37573421Godino JG, Samaniego JC, Sharp SP, Taren D, Zuber A, Armistad AJ, Dezan AM, Leyba AJ, Friedly JL, Bunnell AE, Matthews E, Miller MJ, Unger ER, Bertolli J, Hinckley A, Lin JS, Scott JD, Struminger BB, Ramers C. A technology-enabled multi-disciplinary team-based care model for the management of Long COVID and other fatiguing illnesses within a federally qualified health center: protocol for a two-arm, single-blind, pragmatic, quality improvement professional cluster randomized controlled trial. Trials. 2023 Aug 12;24(1):524. doi: 10.1186/s13063-023-07550-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Ramers, MD principal investigator
Family Health Centers of San Diego
Job Godino, PhD principal investigator
Family Health Centers of San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extension for Community Healthcare Outcomes in people with SARS-CoV-2 Acute Respiratory Disease and Myalgic Encephalomyelitis, run by Family Health Centers of San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 (time frame: During 12 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05167227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.