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| ID | Type | Description | Link |
|---|---|---|---|
| SubOTA 6922-03-COVID-S026 | Other Grant/Funding Number | UPRCCC |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This is a pilot non-randomized-controlled trial to evaluate the impact of "Tomando control de su salud", an evidenced-based intervention for chronic disease self-management in the quality of life of patients living with Long-COVID in Puerto Rico.
Patients from our cohort study entitle "The Puerto Rico COVID-19 Assessment Study" (PR-COAS) (IRB# 2290030465) will be invited to participate in this pilot study during the 12-month follow-up call. Participants with long-COVID and at least one chronic diseases that agree to participate in the pilot study will be allocated into one of the study intervention groups that will participate in the "Tomando Control de su Salud" (TCS) workshops. This group will be asked to answer a final interview approximately one month after the last workshop. Those not interested in participating in the intervention will receive general information about chronic disease management available at the CDC website in Spanish, by email or in person, in addition to their regular health care and will be asked to answer the interview approximately 3 months after the last interview of the PR COAS-cohort.
Investigators expect to enroll approximately 50 participants that will be divide between the groups of intervention and non-intervention. Participants will receive an incentive for transportation and/or parking expenses and for the time dedicated for their participation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group (TCS) | Experimental | Participants with Long-COVID and chronic diseases that agree to participate in the intervention will participate in the "Tomando Control de su Salud" (TCS) workshops. TCS is an evidenced based intervention in Spanish and a culturally appropriate version similar to the Chronic Disease Self-Management program of the Centers for Disease Control and Prevention (CDC) aimed to improve disease management skills, including decision making, problem solving, and action planning among patients with at least one chronic condition. |
|
| Non-Intervention Group (Regular care) | No Intervention | Those not interested in participating in the intervention will receive general information about chronic disease management available at the CDC website in Spanish, by email or in person. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Tomando control de su salud" (Spanish Chronic Disease Self-Management) | Other | "Tomando control de su salud" (Spanish Chronic Disease Self-Management) is a culturally appropriate program developed in Spanish to support Hispanics patients to build confidence in their ability to manage their health. This intervention was developed by Lorig et al. at Stanford University and has been widely used by the Puerto Rico Department of Health since it is recommended by the CDC as an evidenced-based intervention for chronic disease management. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the Impact of Health-related Quality of Life | The following EuroQol (EQ) instrument is used: EQ-5D-5L (Spanish version) scale. This instrument measures quality of life on five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). | 1-3 months |
| Assessment of the Fatigue in the Impact of the Health-related Quality of Life | The investigators use the Fatigue questionnaire (NIH PROMISĀ© Neuro-QoL Item Bank v1.0, Short Form, Spanish version). | 1-3 months |
| Assessment of the Anxiety in the Impact of Health-related Quality of Life | Anxiety (GAD-7, Spanish version) - It is a validated one-dimensional 7-item questionnaire for generalized anxiety disorder assessment, as listed in the DSM-IV. | 1-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Diseases Self-management | Chronic diseases self-management will be assessed through the following scales: Self-Care of Chronic Illness Inventory (SC-CII v4.c, Spanish version): It is an internationally generic measure used to assess self-care in chronic diseases, and it is based on the Theory of Self-Care of Chronic Illness. SC-CII comprises four scales: self-care maintenance (Section A), self-care monitoring (Section B), self-care management (Section C), and self-care confidence (Section D) 31. For the study, investigators will just use the first three sections of this instrument. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enid J Garcia-Rivera, MD, MPH | University of Puerto Rico Medical Sciences Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Dotal de Investigaciones de Servicios de Salud, UPR-MSC (Hospital UPR) | Carolina | PR | 00984 | Puerto Rico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33295675 | Background | Yu DS, De Maria M, Barbaranelli C, Vellone E, Matarese M, Ausili D, Rejane RE, Osokpo OH, Riegel B. Cross-cultural applicability of the Self-Care Self-Efficacy Scale in a multi-national study. J Adv Nurs. 2021 Feb;77(2):681-692. doi: 10.1111/jan.14617. Epub 2020 Dec 9. | |
| 14639082 | Background | Lorig KR, Ritter PL, Gonzalez VM. Hispanic chronic disease self-management: a randomized community-based outcome trial. Nurs Res. 2003 Nov-Dec;52(6):361-9. doi: 10.1097/00006199-200311000-00003. |
| Label | URL |
|---|---|
| Johns Hopkins University, Center for Systems Science and Engineering COVID19 Dashboard. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | The evidenced based intervention "Tomando Control de su Salud" was implemented in this group. The intervention consists of small group workshops with 8 to 15 participants lead by two certified trainers, offered virtually or face-to-face (at the EHSRC Office of Clinical and Community Health Research located at the Hospital UPR in Carolina) for 2 1/2 hours once per week for six-week period open to Spanish-speakers with any physical or mental chronic condition or multiple chronic conditions. |
| FG001 | Control Group | Standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | The evidenced based intervention "Tomando Control de su Salud" was implemented in this group. The intervention consists of small group workshops with 8 to 15 participants lead by two certified trainers, offered virtually or face-to-face (at the EHSRC Office of Clinical and Community Health Research located at the Hospital UPR in Carolina) for 2 1/2 hours once per week for six-week period open to Spanish-speakers with any physical or mental chronic condition or multiple chronic conditions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of the Impact of Health-related Quality of Life | The following EuroQol (EQ) instrument is used: EQ-5D-5L (Spanish version) scale. This instrument measures quality of life on five dimensions: mobility, self-care, daily activities, pain or discomfort, and anxiety or depression. Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). | Posted | Count of Participants | Participants | 1-3 months |
|
From enrollment until end of follow-up, up to 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group (TCS) | Participants with Long-COVID and chronic diseases that agree to participate in the intervention will participate in the "Tomando Control de su Salud" (TCS) workshops. TCS is an evidenced based intervention in Spanish and a culturally appropriate version similar to the Chronic Disease Self-Management program of the Centers for Disease Control and Prevention (CDC) aimed to improve disease management skills, including decision making, problem solving, and action planning among patients with at least one chronic condition. |
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Small number of participants
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Enid J GarcĆa-Rivera | University of Puerto Rico School of Medicine | 787-701-1121 | enid.garcia3@upr.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2024 | May 21, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
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The intervention group will participate in an evidenced-based intervention from chronic disease self-management and the control group will receive usual care and published information for chronic disease management.
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|
| 1-3 months |
| Auto-efficacy for Disease Management | Auto-efficacy will be assessed through the following scales: NIH PROMISĀ© 4-item Short Forms v1.0, 4a - Self-Efficacy for Managing Chronic Conditions, which is a multidimensional categorical model to estimate individual's self-efficacy for managing their heath chronic diseases through the following five behavioral domains:Self-Efficacy for Managing Daily Activities, Self-Efficacy for Managing Emotions, Self-Efficacy for Managing Medications and Treatments, Self-Efficacy for Managing Social Interactions, Self-Efficacy for Managing Symptoms. | 1-3 months |
| Dong, E., Du, H., \& Gardner, L. (2020). An interactive web-based dashboard to track COVID-19 in real time. The Lancet infectious diseases, 20(5), 533-534. | View source |
| Soriano, J. B., Murthy, S., Marshall, J. C., Relan, P., \& Diaz, J. V. (2022). A clinical case definition of post-COVID-19 condition by a Delphi consensus. The Lancet Infectious Diseases, 22(4), e102-e107. ISSN 1473-3099. | View source |
| Post COVID Conditions: Information for Healthcare Provider | View source |
| Davis, H. E., Assaf, G. S., McCorkell, L., Wei, H., Low, R. J., Re'em, Y., ... \& Akrami, A. (2021). Characterizing long COVID in an international cohort: 7 months of symptoms and their impact. EClinicalMedicine, 38, 101019, ISSN 2589-5370. | View source |
| Physical and mental health 3 months after SARS-CoV-2 infection (long COVID) among adolescents in England (CLoCk): A national matched cohort study, The Lancet Child \& Adolescent Health, 6(4), 230-239. | View source |
| Yang, C., Zhao, H., \& Tebbutt, S. J. (2021). Long-term effects on survivors with COVID-19. The Lancet, 398(10314), 1872. | View source |
| National Institutes of Health. (2021). RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults Version 3.0. Accessed 6 April 2022. | View source |
| US Department of Health and Human Services. National Institutes of Health (2022). Patient-reported Outcomes Measure Information Systems (PROMIS). | View source |
| EuroQolResearchFoundation (2019). EQ-5D-5L User Guide: Basic information on how to use the EQ-5D-5L instrument, version 3.0. | View source |
| Riegel, B. (Author) \& Jose, M. M. (Translator). (nd). Self-Care Self-Efficacy Scale (Spanish). | View source |
| U. S. Department of Health and Human Services. (2017). PROMISĀ® (Patient-Reported Outcomes Measurement Information System) Health Measures: Self-Efficacy for Managing Chronic Conditions. PROMIS Item Bank v1.0, Short Forms 4a. | View source |
| Johns Hopkins Bloomberg School of Public Health. (nd). COVID-19 Community Response Survey. Module 5 Comorbidities and Care Engagement. Protocol - Health Conditions, Medications and Health Care during COVID-19 Pandemic (PhenX Toolkit). | View source |
| Johns Hopkins Bloomberg School of Public Health. (2020). COVID-19 Research: History, Treatment and Outcomes. Protocol - Access to Health Services (Spanish version), CDC National Health Interview Survey (NHIS) Utilization Questionnaire, 2020. | View source |
| US Centers for Disease Control and Prevention (2021). Cuestionario del BRFSS 2020. | View source |
| GAD-7 (Spanish version). | View source |
| BG001 | Control Group | Standard of care |
| BG002 | Total | Total of all reporting groups |
| Age in years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Non-Intervention Group (Regular Care) | Those not interested in participating in the intervention will receive general information about chronic disease management available at the CDC website in Spanish, by email or in person. |
|
|
| Primary | Assessment of the Fatigue in the Impact of the Health-related Quality of Life | The investigators use the Fatigue questionnaire (NIH PROMISĀ© Neuro-QoL Item Bank v1.0, Short Form, Spanish version). | Posted | Count of Participants | Participants | 1-3 months |
|
|
|
| Primary | Assessment of the Anxiety in the Impact of Health-related Quality of Life | Anxiety (GAD-7, Spanish version) - It is a validated one-dimensional 7-item questionnaire for generalized anxiety disorder assessment, as listed in the DSM-IV. | Posted | Count of Participants | Participants | 1-3 months |
|
|
|
| Secondary | Chronic Diseases Self-management | Chronic diseases self-management will be assessed through the following scales: Self-Care of Chronic Illness Inventory (SC-CII v4.c, Spanish version): It is an internationally generic measure used to assess self-care in chronic diseases, and it is based on the Theory of Self-Care of Chronic Illness. SC-CII comprises four scales: self-care maintenance (Section A), self-care monitoring (Section B), self-care management (Section C), and self-care confidence (Section D) 31. For the study, investigators will just use the first three sections of this instrument. | Posted | Count of Participants | Participants | 1-3 months |
|
|
|
| Secondary | Auto-efficacy for Disease Management | Auto-efficacy will be assessed through the following scales: NIH PROMISĀ© 4-item Short Forms v1.0, 4a - Self-Efficacy for Managing Chronic Conditions, which is a multidimensional categorical model to estimate individual's self-efficacy for managing their heath chronic diseases through the following five behavioral domains:Self-Efficacy for Managing Daily Activities, Self-Efficacy for Managing Emotions, Self-Efficacy for Managing Medications and Treatments, Self-Efficacy for Managing Social Interactions, Self-Efficacy for Managing Symptoms. | Posted | Count of Participants | Participants | 1-3 months |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Non-Intervention Group (Regular Care) | Those not interested in participating in the intervention will receive general information about chronic disease management available at the CDC website in Spanish, by email or in person. | 0 | 35 | 0 | 35 | 0 | 35 |
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| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Self confidence monitoring health status |
|
| Self confidence identifying changes in health status |
|
| Self confidence in do something to alleviate symptoms |
|