Chronic-disease Self-management Program in Patients Living With Long-COVID in Puerto Rico

University of Puerto Rico (UPR)

Status: Enrolling

Conditions: Long Covid19

Treatments: Other: "Tomando control de su salud" (Spanish Chronic Disease Self-Management)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06208696

2309143222

SubOTA 6922-03-COVID-S026 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention group (TCS)

Experimental group

Description:

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.

Treatment:

Other: "Tomando control de su salud" (Spanish Chronic Disease Self-Management)

Non-Intervention Group (Regular care)

No Intervention group

Description:

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.