Chronic-disease Self-management Program in Patients Living With Long-COVID in Puerto Rico
- Conditions
- Long Covid19
- Interventions
- Other: "Tomando control de su salud" (Spanish Chronic Disease Self-Management)
- Registration Number
- NCT06208696
- Lead Sponsor
- University of Puerto Rico
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group (TCS) "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.
- Primary Outcome Measures
Name Time Method 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 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 Post-COVID 19 in the impact of health-related quality of life 1-3 months 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.
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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Centro Dotal de Investigaciones de Servicios de Salud, UPR-MSC (Hospital UPR)
🇵🇷Carolina, Puerto Rico