An interventional study of "Tomando control de su salud" (Spanish Chronic Disease Self-Management) in Long Covid19, sponsored by University of Puerto Rico. Completed at 1 site in Puerto Rico. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University of Puerto Rico · Not applicable, Interventional, and Supportive care
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.
520 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 186 are open to participants now.
This study's enrollment of 47 is below the median of 60 across 361 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →University of Puerto Rico is the lead sponsor of 45 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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.
"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.
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).
Time frame: 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).
Time frame: 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.
Time frame: 1-3 months
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.
Time frame: 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.
Time frame: 1-3 months
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 12 | 35 |
| Completed | 12 | 35 |
| Not completed | 0 | 0 |
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).
| Participants | Intervention Group (TCS) | Non-Intervention Group (Regular Care) |
|---|---|---|
| Reported excellent health | 4 | 3 |
| Reported excellent quality of life | 4 | 6 |
| Reported excellent physical health | 2 | 3 |
| Reporting excellent mental health | 6 | 25 |
| Reporting satisfaction with social life | 6 | 11 |
The investigators use the Fatigue questionnaire (NIH PROMIS© Neuro-QoL Item Bank v1.0, Short Form, Spanish version).
| Participants | Intervention Group (TCS) | Non-Intervention Group (Regular Care) |
|---|---|---|
| Ability to perform social activities all the time | 9 | 19 |
| Ability to perform physical activities all the time | 9 | 20 |
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.
| Participants | Intervention Group (TCS) | Non-Intervention Group (Regular Care) |
|---|---|---|
| Frequently or most of the time affected by anxiety in the last 7 days | 2 | 6 |
| Intense tiredness in the last 7 days | 1 | 11 |
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.
| Participants | Intervention Group (TCS) | Non-Intervention Group (Regular Care) |
|---|---|---|
| Daily monitoring blood glucose levels | 1 | 4 |
| Daily monitoring blood pressure | 3 | 6 |
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.
| Participants | Intervention Group (TCS) | Non-Intervention Group (Regular Care) |
|---|---|---|
| Self confidence in maintaining symptoms under control | 11 | 27 |
| Self confidence in following the treatment | 11 | 31 |
| Self confidence monitoring health status | 12 | 32 |
| Self confidence identifying changes in health status | 12 | 30 |
| Self confidence in do something to alleviate symptoms | 12 | 33 |
Collected over From enrollment until end of follow-up, up to 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group (TCS) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Non-Intervention Group (Regular Care) | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Age, Continuous(Age in years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 49.5 ± 8.4 | 52.7 ± 14.6 | 51.9 ± 13.3 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Female | 11 | 27 | 38 |
| Male | 1 | 8 | 9 |
| Race and Ethnicity Not Collected(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Puerto Rico | 12 | 35 | 47 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Puerto Rico