Clinical trial NCT06208696: Chronic-disease Self-management Program in Patients Living With Long-COVID in Puerto Rico
Official title: Pilot Study to Evaluate the Role of an Evidenced-based Chronic-disease Self-management Program to Support Challenges Experiencing Patients Living With Long-COVID and Chronic Diseases in Puerto Rico
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long Covid19
Keywords: Long COVID19
chronic disease self-management
evidenced-based program
health-related quality of life
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of the impact of health-related quality of life
timeFrame: 1-3 months
measure: Assessment of the fatigue in the impact of the health-related quality of life
timeFrame: 1-3 months
measure: Assessment of the Post-COVID 19 in the impact of health-related quality of life
timeFrame: 1-3 months
measure: Assessment of the anxiety in the impact of health-related quality of life
timeFrame: 1-3 months
Secondary outcomes:
measure: Chronic diseases self-management
timeFrame: 1-3 months
measure: Auto-efficacy for disease management
timeFrame: 1-3 months
Other outcomes:
Locations:
city: Carolina
country: Puerto Rico
facility: Centro Dotal de Investigaciones de Servicios de Salud, UPR-MSC (Hospital UPR)
Study officials:
affiliation: University of Puerto Rico Medical Sciences Campus
name: Enid J Garcia-Rivera, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu DS, De Maria M, Barbaranelli C, Vellone E, Matarese M, Ausili D, Rejane RE, Osokpo OH, Riegel B. Cross-cultural applicability of the Self-Care Self-Efficacy Scale in a multi-national study. J Adv Nurs. 2021 Feb;77(2):681-692. doi: 10.1111/jan.14617. Epub 2020 Dec 9.
citation: Lorig KR, Ritter PL, Gonzalez VM. Hispanic chronic disease self-management: a randomized community-based outcome trial. Nurs Res. 2003 Nov-Dec;52(6):361-9. doi: 10.1097/00006199-200311000-00003.