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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-02

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Long Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group (TCS)

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

"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.

Non-Intervention Group (Regular care)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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"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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No