Trial Outcomes & Findings for Chronic-disease Self-management Program in Patients Living With Long-COVID in Puerto Rico (NCT NCT06208696)
NCT ID: NCT06208696
Last Updated: 2026-05-22
Results Overview
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).
COMPLETED
NA
47 participants
1-3 months
2026-05-22
Participant Flow
Participant milestones
| Measure |
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.
|
Control Group
Standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
35
|
|
Overall Study
COMPLETED
|
12
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=12 Participants
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.
|
Control Group
n=35 Participants
Standard of care
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.5 Age in years
STANDARD_DEVIATION 8.4 • n=12 Participants
|
52.7 Age in years
STANDARD_DEVIATION 14.6 • n=35 Participants
|
51.9 Age in years
STANDARD_DEVIATION 13.3 • n=47 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=12 Participants
|
27 Participants
n=35 Participants
|
38 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=12 Participants
|
8 Participants
n=35 Participants
|
9 Participants
n=47 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Puerto Rico
|
12 Participants
n=12 Participants
|
35 Participants
n=35 Participants
|
47 Participants
n=47 Participants
|
PRIMARY outcome
Timeframe: 1-3 monthsThe 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).
Outcome measures
| Measure |
Intervention Group (TCS)
n=12 Participants
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)
n=35 Participants
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.
|
|---|---|---|
|
Assessment of the Impact of Health-related Quality of Life
Reported excellent health
|
4 Participants
|
3 Participants
|
|
Assessment of the Impact of Health-related Quality of Life
Reported excellent quality of life
|
4 Participants
|
6 Participants
|
|
Assessment of the Impact of Health-related Quality of Life
Reported excellent physical health
|
2 Participants
|
3 Participants
|
|
Assessment of the Impact of Health-related Quality of Life
Reporting excellent mental health
|
6 Participants
|
25 Participants
|
|
Assessment of the Impact of Health-related Quality of Life
Reporting satisfaction with social life
|
6 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 1-3 monthsThe investigators use the Fatigue questionnaire (NIH PROMIS© Neuro-QoL Item Bank v1.0, Short Form, Spanish version).
Outcome measures
| Measure |
Intervention Group (TCS)
n=12 Participants
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)
n=35 Participants
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.
|
|---|---|---|
|
Assessment of the Fatigue in the Impact of the Health-related Quality of Life
Ability to perform physical activities all the time
|
9 Participants
|
20 Participants
|
|
Assessment of the Fatigue in the Impact of the Health-related Quality of Life
Ability to perform social activities all the time
|
9 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: 1-3 monthsAnxiety (GAD-7, Spanish version) - It is a validated one-dimensional 7-item questionnaire for generalized anxiety disorder assessment, as listed in the DSM-IV.
Outcome measures
| Measure |
Intervention Group (TCS)
n=12 Participants
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)
n=35 Participants
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.
|
|---|---|---|
|
Assessment of the Anxiety in the Impact of Health-related Quality of Life
Frequently or most of the time affected by anxiety in the last 7 days
|
2 Participants
|
6 Participants
|
|
Assessment of the Anxiety in the Impact of Health-related Quality of Life
Intense tiredness in the last 7 days
|
1 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1-3 monthsChronic 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.
Outcome measures
| Measure |
Intervention Group (TCS)
n=12 Participants
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)
n=35 Participants
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.
|
|---|---|---|
|
Chronic Diseases Self-management
Daily monitoring blood glucose levels
|
1 Participants
|
4 Participants
|
|
Chronic Diseases Self-management
Daily monitoring blood pressure
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1-3 monthsAuto-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.
Outcome measures
| Measure |
Intervention Group (TCS)
n=12 Participants
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)
n=35 Participants
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.
|
|---|---|---|
|
Auto-efficacy for Disease Management
Self confidence in maintaining symptoms under control
|
11 Participants
|
27 Participants
|
|
Auto-efficacy for Disease Management
Self confidence in following the treatment
|
11 Participants
|
31 Participants
|
|
Auto-efficacy for Disease Management
Self confidence monitoring health status
|
12 Participants
|
32 Participants
|
|
Auto-efficacy for Disease Management
Self confidence identifying changes in health status
|
12 Participants
|
30 Participants
|
|
Auto-efficacy for Disease Management
Self confidence in do something to alleviate symptoms
|
12 Participants
|
33 Participants
|
Adverse Events
Intervention Group (TCS)
Non-Intervention Group (Regular Care)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Enid J García-Rivera
University of Puerto Rico School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place