Long Covid19NCT06208696
Chronic-disease Self-management Program in Patients Living With Long-COVID in Puerto Rico
A study of Long Covid19, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Long Covid19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 2 Nov 2023to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Centro Dotal de Investigaciones de Servicios de Salud, UPR-MSC (Hospital UPR)
Carolina, PR, 00984
About this study
Official title: Pilot Study to Evaluate the Role of an Evidenced-based Chronic-disease Self-management Program to Support Challenges Experiencing Patients Living With Long-COVID and Chronic Diseases in Puerto Rico
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.
Read the detailed description
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.
- Conditions
- Long Covid19
- Being tested
- "Tomando control de su salud" (Spanish Chronic Disease Self-Management)
- Keywords
- Long COVID19, chronic disease self-management, evidenced-based program, health-related quality of life
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 1-3 months
Secondary outcomes (2)
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.
Measured: 1-3 months
Auto-efficacy for Disease Management
Auto-efficacy will be assessed through the following scales:
NIH PROMIS© 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.
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start2 Nov 2023
- Primary completion29 Feb 2024
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Long Covid19Studies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Enid J. Garcia-Rivera, University of Puerto Rico
- Investigators
- Enid J Garcia-Rivera, MD, MPH, Principal investigator, University of Puerto Rico Medical Sciences Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208696
- Sponsor's protocol ID
- 2309143222
- Other IDs
- SubOTA 6922-03-COVID-S026
- Status last verified
- May 2026
- First submitted
- 11 Dec 2023
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33295675Lorig 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.
PubMed 14639082
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Role of an Evidenced-based Chronic-disease Self-management Program to Support Challenges Experiencing Patients Living With Long-COVID and Chronic Diseases in Puerto Rico
- ClinicalTrials.gov ID
- NCT06208696
- Acronym / sponsor ID
- 2309143222
- Conditions
- Long Covid19
- Keywords
- Long COVID19, chronic disease self-management, evidenced-based program, health-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (TCS) | Experimental | Other: "Tomando control de su salud" (Spanish Chronic Disease Self-Management)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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| "Tomando control de su salud" (Spanish Chronic Disease Self-Management)"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. | Other | Intervention group (TCS) |
Primary outcome
Assessment of the Impact of Health-related Quality of Life
Time frame: 1-3 months
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).
Assessment of the Fatigue in the Impact of the Health-related Quality of Life
Time frame: 1-3 months
The investigators use the Fatigue questionnaire (NIH PROMIS© Neuro-QoL Item Bank v1.0, Short Form, Spanish version).
Assessment of the Anxiety in the Impact of Health-related Quality of Life
Time frame: 1-3 months
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.
2 secondary outcomes
Chronic Diseases Self-management
Time frame: 1-3 months
Auto-efficacy for Disease Management
Time frame: 1-3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33295675Yu 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.
- Background: PubMed 14639082Lorig 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.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Post COVID Conditions: Information for Healthcare ProviderLink provided by the sponsor.
- Groff, D., Sun, A., Ssentongo, A. E., Ba, D. M., Parsons, N., Poudel, G. R., ... \& Chinchilli, V. M. (2021). Short-term and long-term rates of postacute sequelae of SARS-CoV-2 infection: a systematic review. JAMA network open, 4(10), e2128568-e2128568.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.
Enid J Garcia-Rivera, MD, MPH principal investigator
University of Puerto Rico Medical Sciences Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Long Covid19, run by University of Puerto Rico at 1 site in Puerto Rico.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 May 2026. 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 Puerto Rico. 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?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of the Impact of Health-related Quality of Life (time frame: 1-3 months). The study lists 3 primary outcomes in all. 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 NCT06208696, which also lists 2 linked publications.
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 22 May 2026.