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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Assessment of the fatigue in the impact of the health-related quality of life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: "Tomando control de su salud" (Spanish Chronic Disease Self-Management) (Other)
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.
结局指标
主要结局
Assessment of the fatigue in the impact of the health-related quality of life
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Chronic diseases self-management(1-3 months)
- Auto-efficacy for disease management(1-3 months)
研究者
Enid J. Garcia-Rivera
Associate Professor
University of Puerto Rico