Long Covid19
Conditions
Keywords
Long COVID19, chronic disease self-management, evidenced-based program, health-related quality of life
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.
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.
Interventions
OTHER"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.
Sponsors
University of Puerto Rico
National Institutes of Health (NIH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients 21 years or older; 2. Participant of PR COAS-cohort that completed the last interview (12-month-follow-up) and authorized to be contacted for further studies; 3. Having at least one chronic condition (excluding cancer) diagnosed by a physician or healthcare provider, and 4. Ability to attend weekly sessions.
Exclusion criteria
1. Any clinical or cognitive impairment that limits the participant's ability to decide to participate in the study or complete the interviews; 2. presence of a life threatening or extreme medical condition, and 3. planning to move out of the municipality within the next year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Impact of Health-related Quality of Life | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Diseases Self-management | 1-3 months | 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. |
| Auto-efficacy for Disease Management | 1-3 months | 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. |
Countries
Puerto Rico
Contacts
PRINCIPAL_INVESTIGATOREnid J Garcia-Rivera, MD, MPH
University of Puerto Rico Medical Sciences Campus
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49.5 Age in years STANDARD_DEVIATION 8.4 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Puerto Rico | 35 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 35 |
| other Total, other adverse events | 0 / 12 | 0 / 35 |
| serious Total, serious adverse events | 0 / 12 | 0 / 35 |
Outcome results
None listed