Effectiveness of a Personalized In-home Telerehabilitation Program on Self-Care in Patients with Long COVID
RESPICARE
1 other identifier
interventional
60
1 country
1
Brief Summary
The goal of this clinical trial is to evaluate whether a 12-week tele-rehabilitation programme with monitoring via a mobile app produces medium-term improvements in self-management, fatigue and quality of life in patients affected by persistent COVID. The main questions it aims to answer are:
- Will a multimodal program (exercise with education) improve the self-management ability of patients with post-exertional malaise?
- Does fatigue and quality of life will be improved in these patients? Researchers will compare an experimental breath program to a control standard care group to see if multimodal program works to treat post-exertion malaise. Participants will:
- Follow-up 12 weeks online sessions: 1 weekly synchronous online session + 1 scheduled asynchronous session + educational resources
- Daily use of the app: daily log, education and questions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2025
CompletedFirst Posted
Study publicly available on registry
February 12, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
February 18, 2025
January 1, 2025
1.3 years
February 11, 2025
February 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient activation measure 13
Individual's knowledge, skills and confidence to managing one's own health. is a non-disease-specific tool and can be used across different patient populations. The PAM-13 consists of 13 items on a 4-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Item scores are summed up to a raw sum score resulting in theoretical values between 13 and 52, which are then transformed to a standardized metric ranging from 0 to 100. Higher scores indicate a greater patient activation. PAM-13 scores can then be categorized into four stages of activation, corresponding to the difficulty of the PAM-13 items: level 1 (patients believe active role is important; items 1-2), level 2 (patients have confidence and knowledge to take action; items 3-8), level 3 (taking action; items 9-11) and level 4 (staying on course under stress; items 12-13).
From enrollment to end of treatment and 3 months follow-up
self-care self-efficacy scale
Measure for self-care self-efficacy for chronic illness. This 10-item instrument measures self-efficacy related to self-care maintenance, monitoring, and management in patients with chronic illness. Each item is rated on a '1-5' rating scale, with a higher score representing a higher level of self-efficacy. Scale scores are standardized mathematically to range from 0-100.
From enrollment to end of treatment and 3 months follow-up
Secondary Outcomes (3)
Health-related quality of life EuroQol-5D
From enrollment to end of treatment and 3 months follow-up
Fatigue Severity Scale (FSS)
From enrollment to end of treatment and 3 months follow-up
DePaul Symptom Questionnaire-Short Form (DSQ-SF)
From enrollment to end of treatment and 3 months follow-up
Study Arms (2)
Telerehabilitation program
EXPERIMENTALThe interventions include: * Education for self-management * Personalised exercise program
Control
ACTIVE COMPARATORUsual care
Interventions
Education program performed online including information, recommendations and guidance for promoting self-management
Individualized exercise that includes progressive load adapted to each patient. It includes making flexible adjustments to their exercise (up or down as needed) to help them gradually improve their physical abilities while staying within their energy limits
Eligibility Criteria
You may qualify if:
- Post COVID-19 condition: individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of breath, cognitive dysfunction
- Between 18 and 75 years of age
- Possibility of access and use of smartphone.
- Ability to attend the clinic in person for an initial session.
You may not qualify if:
- Patients with a history of respiratory or cardiovascular diseases prior to COVID-19, other acute or chronic diseases that may interfere with the study
- Pregnancy/breastfeeding
- Those with contraindications to respiratory muscle training.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CEU San Pablo University
Madrid, Madrid, 28003, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2025
First Posted
February 12, 2025
Study Start
March 1, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
February 18, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share