Chronic-disease Self-management Program in Patients Living With Long-COVID in Puerto Rico

NCT06208696 | Unknown

• 2 other identifiers: 2309143222SubOTA 6922-03-COVID-S026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Long Covid19

Keywords

Long COVID19; chronic disease self-management; evidenced-based program; health-related quality of life

Outcome Measures

Primary Outcomes (4)

• 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 PROMIS© Neuro-QoL Item Bank v1.0, Short Form, Spanish version).

  1-3 months

• Assessment of the Post-COVID 19 in the impact of health-related quality of life

  Investigators uses the Post-COVID-19 Functional Status Scale (PCFS, Spanish version). An ordinal tool that focuses on relevant aspects of daily life during follow-up after the COVID-19 infection (Klok et al., 2020). PCFS includes the entire range of functional outcomes by focusing on limitations (if any) in usual duties/activities either at home or at work/study, as well as changes in lifestyle.

  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

Secondary Outcomes (2)

• Chronic diseases self-management

  1-3 months

• Auto-efficacy for disease management

  1-3 months

Study Arms (2)

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.

Other: "Tomando control de su salud" (Spanish Chronic Disease Self-Management)

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.

Interventions

"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.

Intervention group (TCS)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients 21 years or older;
• Participant of PR COAS-cohort that completed the last interview (12-month-follow-up) and authorized to be contacted for further studies;
• Having at least one chronic condition (excluding cancer) diagnosed by a physician or healthcare provider, and
• Ability to attend weekly sessions.

You may not qualify if:

• Any clinical or cognitive impairment that limits the participant's ability to decide to participate in the study or complete the interviews;
• presence of a life threatening or extreme medical condition, and
• planning to move out of the municipality within the next year.

Sponsors & Collaborators

• University of Puerto Rico: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Centro Dotal de Investigaciones de Servicios de Salud, UPR-MSC (Hospital UPR)

Carolina, PR, 00984, Puerto Rico

RECRUITING

Related Publications (2)

• 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.

  PMID: 33295675 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.

  PMID: 14639082 BACKGROUND

Related Links

• Johns Hopkins University, Center for Systems Science and Engineering COVID19 Dashboard.
• 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.
• 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.
• 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.
• 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.
• Yang, C., Zhao, H., \& Tebbutt, S. J. (2021). Long-term effects on survivors with COVID-19. The Lancet, 398(10314), 1872.
• 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.
• US Department of Health and Human Services. National Institutes of Health (2022). Patient-reported Outcomes Measure Information Systems (PROMIS).
• EuroQolResearchFoundation (2019). EQ-5D-5L User Guide: Basic information on how to use the EQ-5D-5L instrument, version 3.0.
• Riegel, B. (Author) \& Jose, M. M. (Translator). (nd). Self-Care Self-Efficacy Scale (Spanish).
• U. S. Department of Health and Human Services. (2017). PROMIS® (Patient-Reported Outcomes Measurement Information System) Health Measures: Self-Efficacy for Managing Chronic Conditions. PROMIS Item Bank v1.0, Short Forms 4a.
• 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).
• 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.
• US Centers for Disease Control and Prevention (2021). Cuestionario del BRFSS 2020.
• GAD-7 (Spanish version).

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enid J Garcia-Rivera, MD, MPH

  University of Puerto Rico Medical Sciences Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enid J Garcia-Rivera, MD, MPH

CONTACT

(787) 701-1121; enid.garcia3@upr.edu

Maria C Larriuz-Serrano, MS, MPH

CONTACT

(787) 701-1121; maria.larriuz@upr.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 17, 2024
• Study Start: November 2, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1)