Effectiveness of a Personalized In-home Telerehabilitation Program on Self-Care in Patients with Long COVID

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCEU San Pablo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Education for self-management

    Other intervention

    Education program performed online including information, recommendations and guidance for promoting self-management

  • Personalised exercise program

    Other intervention

    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

  • Usual Care

    Other intervention

    Usual care these patients may receive out from the clinical trial.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Telerehabilitation programExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
From enrollment to end of treatment and 3 months follow-up
2

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.

Time frame
From enrollment to end of treatment and 3 months follow-up

Secondary outcomes

1

Health-related quality of life EuroQol-5D

Quality of life related to dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is described by three possible levels of problems (no, mild to moderate and severe). Hence, this descriptive system contains three or 243 combinations, or health states. For each of these combinations, one can assign healthstate utility indices (or ''preference weights'') which are based on different value sets.

Time frame
From enrollment to end of treatment and 3 months follow-up
2

Fatigue Severity Scale (FSS)

Severity of fatigue and its effect on a person's activities and lifestyle. The FSS questionnaire contains nine statements that rate the severity of your fatigue symptoms. Read each statement and circle a number from 1 to 7, based on how accurately it reflects your condition during the past week and the extent to which you agree or disagree that the statement applies to you. A low value (e.g., 1) indicates strong disagreement with the statement, whereas a high value (e.g., 7) indicates strong agreement. The minimum score=9 and maximum score possible=63. Higher the score=greater fatigue severity.

Time frame
From enrollment to end of treatment and 3 months follow-up
3

DePaul Symptom Questionnaire-Short Form (DSQ-SF)

The DSQ-SF allows investigators to use a small number of items (n = 14) to determine whether patients meet ME/CFS case definitions. Similar to the DSQ, the DSQ-SF uses the mean of the frequency and severity scores for each symptom rated over the past 6 months and linearly transforming it into a 100-point scale

Time frame
From enrollment to end of treatment and 3 months follow-up

Other outcomes

Sponsors and contacts

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